Ahmed Galal, MD

• Professor of Medicine
• Member of the Duke Cancer Institute

https://medicine.duke.edu/faculty/ahmed-galal-md

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See also Oral isotretinoin Staphylococcus aureus Systemic lupus erythematosus, 670, 675, 676 Index 767 Systemi isotretinoin. Reports regarding the medical status of an airman should be written by their treating provider. Examiners shall certify at the time of designation, re-designation, or upon request that they possess (and maintain as necessary) the equipment specified. A Wall Target consisting of a 50-inch square surface with a matte finish (may be black felt or dull finish paper) and a 2-mm white test object (may be a pin) in a suitable handle of the same color as the background. Standard physician diagnostic instruments and aids including those necessary to perform urine testing for albumin and glucose and those to measure height and weight. Examiners may re-issue an airman medical certificate under the provisions of an Authorization, if the applicant provides the requisite medical information required for determination. No "Alternate" Examiners Designated the Examiner is to conduct all medical examinations at their designated address only. An Examiner is not permitted to conduct examinations at a temporary address and is not permitted to name an alternate Examiner. Age Requirements There is no age restriction or aviation experience requirement for medical certification. First-Class Airline Transport Pilot Second-Class Commercial Pilot; Flight Engineer; Flight Navigator; or Air Traffic Control Tower Operator. First-Class Medical Certificate: A first-class medical certificate is valid for the remainder of the month of issue; plus 6-calendar months for operations requiring a first-class medical certificate if the airman is age 40 or over on or before the date of the examination, or plus 12-calendar months for operations requiring a first-class medical certificate if the airman has not reached age 40 on or before the date of examination 12-calendar months for operations requiring a second-class medical certificate, or plus 24-calendar months for operations requiring a third-class medical certificate, or plus 60-calendar months for operations requiring a third-class medical certificate if the airman has not reached age 40 on or before the date of examination. Second-Class Medical Certificate: A second-class medical certificate is valid for the remainder of the month of issue; plus 12-calendar months for operations requiring a second-class medical certificate, or plus 24-calendar months for operations requiring a third-class medical certificate, or plus 60-calendar months for operations requiring a third-class medical certificate if the airman has not reached age 40 on or before the date of examination. The replacement certificate will be prepared in the same manner as the missing certificate and will bear the same date of examination regardless of when it is issued. The date for Item 16 may be estimated if the applicant does not recall the actual date of the last examination. However, for the sake of electronic transmission, it must be placed in the mm/dd/yyyy format. If the explanation is not reasonable (legal name change, subsequent marriage, etc. The class of medical certificate sought by the applicant is needed so that the appropriate medical standards may be applied. For example, an aviation student may ask for a first-class medical certificate to see if he or she qualifies medically before entry into an aviation career. The Examiner should never issue more than one certificate based on the same examination. If they decline to provide one or are an international applicant, they must check the appropriate box and a number will be generated for them. Date of Birth the applicant must enter the numbers for the month, day, and year of birth in order. Total Pilot Time Past 6 Months the applicant should provide the number of civilian flight hours in the 6-month period immediately preceding the date of this application. The applicant should indicate whether near vision contact lens(es) is/are used while flying. Examples of unacceptable use include: fi the use of a contact lens in one eye for near vision and in the other eye for distant vision (for example: pilots with myopia plus presbyopia). Affirmative answers alone in Item 18 do not constitute a basis for denial of a medical certificate. Experience has shown that, when asked direct questions by a physician, applicants are likely to be candid and willing to discuss medical problems. The Examiner should attempt to establish rapport with the applicant and to develop a complete medical history. Under all circumstances, please advise the examining eye specialist to explain why the airman is unable to correct to Snellen visual acuity of 20/20. For other lung conditions, a detailed description of symptoms/diagnosis, surgical intervention, and medications should be provided. Part 67 provides that, for all classes of medical certificates, an established medical history or clinical diagnosis of myocardial infarction, angina pectoris, cardiac valve replacement, permanent cardiac pacemaker implantation, heart replacement, or coronary heart disease that has required treatment or, if untreated, that has been symptomatic or clinically significant, is cause for denial. The applicant should provide history and treatment, pertinent medical records, current status report and medication. If a 33 Guide for Aviation Medical Examiners procedure was done, the applicant must provide the report and pathology reports. Like all other conditions of aeromedical concern, the history surrounding the event is crucial. An applicant with an established history of a personality disorder that is severe enough to have repeatedly manifested itself by overt acts, a psychosis disorder, or a bipolar disorder must be denied or deferred by the Examiner. Because motion sickness varies with the nature of the stimulus, it is most helpful to know if the problem has occurred in flight or under similar circumstances. If the person has received a military medical discharge, the Examiner should take additional history and record it in Item 60. The fact that the applicant is receiving disability benefits does not necessarily mean that the application should be denied. The Examiner should inquire about the place, cause, and date of rejection and enter the information in Item 60. For each admission, the applicant should list the dates, diagnoses, duration, treatment, name of the attending physician, and complete address of the hospital or clinic. The Examiner must document the specifics and nature of the disability in findings in Item 60. The applicant should give the name, date, address, and type of health professional consulted and briefly state the reason for the consultation. When an applicant does provide history in Item 19, the Examiner should review the matter with the applicant. The Examiner will record in Item 60 only that information needed to document the review and provide the basis for a certification decision. If the Examiner finds the information to be of a personal or sensitive nature with no relevancy to flying safety, it should be recorded in Item 60 as follows: 36 Guide for Aviation Medical Examiners "Item 19. Although there are no medical standards for height, exceptionally short individuals may not be able to effectively reach all flight controls and must fly specially modified aircraft. Since height is commonly measured in centimeters, divide height in centimeters by 100 to obtain height in meters. If the Examiner finds the condition has become worse, a medical certificate should not be issued even if the applicant is otherwise qualified. Discharge or granulation tissue may be the only observable indication of perforation. Mobility should be demonstrated by watching the drum through the otoscope during a valsalva maneuver. An applicant with unilateral congenital or acquired deafness should not be denied medical certification if able to pass any of the tests of hearing acuity. If the applicant is unable to pass any of the above tests without the use of hearing aids, he or she may be tested using hearing aids. For example, if the medication half-life is 6-8 hours, wait 40 hours (5x8) after the last dose to fly. Is there a history of serious eye disease such as glaucoma or other disease commonly associated with secondary eye changes, such as diabetesfi It is recommended that the Examiner consider the following signs during the course of the eye examination: 1. The Examiner then brings the light to center front and advances it toward the nose observing for convergence. End point nystagmus is a physiologic nystagmus and is not considered to be significant. Although it has been repeatedly demonstrated that binocular vision is not a prerequisite for flying, some aspects of depth perception, either by stereopsis or by monocular cues, are necessary. It takes time for the monocular airman to develop the techniques to interpret the monocular cues that substitute for stereopsis; such as, the interposition of objects, convergence, geometrical perspective, distribution of light and shade, size of known objects, aerial perspective, and motion parallax. For the above reasons, a waiting period of 6 months is recommended to permit an adequate adjustment period for learning techniques to interpret monocular cues and accommodation to the reduction in the effective visual field. Additionally, designer contact lenses that introduce color (tinted lenses), restrict the field of vision, or significantly diminish transmitted light are not allowed. The correction is not permanent and visual acuity can regress while not wearing the Ortho-K lenses. There is no reasonable or reliable way to determine standards for the entire period the lenses are removed. The so-called "blue blockers" may not be suitable since they block the blue light used in many current panel displays. The waiting period is required to permit adequate adjustment period for fluctuating visual acuity. Examples include retinal detachment with surgical correction, open angle glaucoma under adequate control with medication, and narrow angle glaucoma following surgical correction. The Examiner may issue a certificate after cataract surgery for applicants who have undergone cataract surgery with or without lens(es) implant. If nystagmus has been present for a number of years and has not recently worsened, it is usually necessary to consider only the impact that the nystagmus has upon visual acuity. The applicant should be advised of any abnormality that is detected, then deferred for further evaluation. Airmen who are exhibiting symptoms, regardless of the treatment used, must not fly. Examiner must caution airman not to fly until course of oral steroids is completed and airman is symptom free. If the applicant has frequent exacerbations or any degree of exertional dyspnea, certification should be deferred. On the other hand, an individual who has sustained a repeat pneumothorax normally is not eligible for certification until surgical interventions are carried out to correct the underlying problem. A person who has such a history is usually able to resume airmen duties 3 months after the surgery. A brief description of any comment-worthy personal characteristics as well as height, weight, representative blood pressure readings in both arms, funduscopic examination, condition of peripheral arteries, carotid artery auscultation, heart size, heart rate, heart rhythm, description of murmurs (location, intensity, timing, and opinion as to significance), and other findings of consequence must be provided. Check the hematopoietic and vascular system by observing for pallor, edema, varicosities, stasis ulcers, and venous distention. The medical standards do not specify pulse rates that, per se, are disqualifying for medical certification. Bradycardia of less than 50 beats per minute, any episode of tachycardia during the course of the examination, and any other irregularities of pulse other than an occasional ectopic beat or sinus arrhythmia must be noted and reported. Temporary stresses or fever may, at times, result in abnormal results from these tests. It should be noted whether it is functional or organic and if a special examination is needed. It is recommended that the Examiner conduct the auscultation of the heart with the applicant both in a sitting and in a recumbent position. Standardization of examination methods and reporting is essential to provide sufficient basis for making determinations and the prompt processing of applications. Particular reference should be given to cardiovascular abnormalities cerebral, visceral, and/or peripheral. A statement of the ages and health status of parents and siblings is required; if deceased, cause and age at death should be included. The presence of an aneurysm or obstruction of a major vessel of the body is disqualifying for medical certification of any class. The maximum systolic during exam is 155mmHg and the maximum diastolic is 95mmHg during the exam. The airman had medication(s) adjusted and now meets the standards, but it took longer than 14 days and the exam was deferred. The treating physician note should describe the clinical rationale as to why the unacceptable medication was previously chosen and why it is ok for the airmen to be on a different medication now. Applicants for first or second-class must provide this information annually; applicants for third-class must provide the information with each required exam. Hypertrophy or dilatation of the heart as evidenced by clinical examination and supported by diagnostic studies. A 1 month observation period must elapse after the procedure before consideration for certification. Check the hematopoietic and vascular system by observing for pallor, edema, varicosities, stasis ulcers, venous distention, nail beds for capillary pulsation, and color. A history of acute gastrointestinal disorders is usually not disqualifying once recovery is achieved. The Examiner should not issue a medical certificate if the applicant has a recent history of bleeding ulcers or hemorrhagic colitis. In the case of a history of bowel obstruction, a report on the cause and present status of the condition must be obtained from the treating physician. Applicants for first or second class must provide this information annually; applicants for third-class must provide the information with each required exam. Recurrence any evidence or concern based on [ ] No colonoscopy or imaging studies per acceptable current practice guidelines. If the digital rectal examination is not performed, the response to Item 39 may be based on direct observation or history. Examination Techniques A careful examination of the skin may reveal underlying systemic disorders of clinical importance. Needle marks that suggest drug abuse should be noted and body marks and scars should be described and correlated with known history. Disorders such as sterility and menstrual irregularity are not usually of importance in qualification for medical certification. Notes: If the airman is currently on radiation or chemotherapy, the treatment course should be completed before medical certification can be considered. Testicular Cancer and treatment completed Worksheet less than 5 years ago Note in Block 60. Motion coordination, tremors, loss or restriction of joint motions, and performance degradation 122 Guide for Aviation Medical Examiners 5. If the applicant is asymptomatic, has completely recovered from surgery, is taking no medication, and has suffered no neurological deficit, the Examiner should confirm these facts in a brief statement in Item 60. The Examiner should defer issuance and may advise the applicant to request a Medical Flight Test. Examination Techniques A careful examination for surgical and other scars should be made, and those that are significant (the result of surgery or that could be useful as identifying marks) should be described. Medical documentation must be submitted for any condition in order to support an issuance of a medical certificate. Certain laboratory studies, such as scans and imaging procedures of the head or spine, electroencephalograms, or spinal paracentesis may suggest significant medical history. Some require only temporary disqualification during periods when the headaches are likely to occur or require treatment. Other types of headaches may preclude certification by the Examiner and require special evaluation and consideration. The basic neurological examination consists of an examination of the 12 cranial nerves, motor strength, superficial reflexes, deep tendon reflexes, sensation, coordination, mental status, and includes the Babinski reflex and Romberg sign. Processing such applications can be expedited by including hospital records, consultation reports, and appropriate laboratory and imaging studies, if available. Recurrent symptomatology may interfere with flight performance through mechanisms such as seizure, headaches, vertigo, visual disturbances, or confusion. A neurological and/or general medical consultation will be necessary in most instances. Factors that would be considered in determining eligibility in such cases would be age at onset, nature and frequency of seizures, precipitating causes, and duration of stability without medication. During this most recent spell, which of the following best describes your awareness of [ ] Somewhat aware, the surroundingsfi During this spell, did you behave in unusual ways such as smacking your lips, touching your clothes, or doing any other unusual things without intending tofi Behaving in unusual ways such as smacking your lips, touching your clothes, or doing any other unusual things without intending tofi

The relative amount of pain after a vaginal hysterectomy is less than with abdominal hysterectomy and muscle relaxant triazolam cheap rumalaya gel online visa, in the absence of additional repairs or a pack iphone 5 spasms purchase rumalaya gel 30 gr line, no obstructive effect should be present muscle relaxant natural remedies rumalaya gel 30 gr on-line. If the patient does not tolerate pain well postoperatively or is extremely anxious infantile spasms 2012 generic rumalaya gel 30gr with visa, the transurethral insertion of a 16-Fr spasms and spasticity order rumalaya gel australia. This catheter may be inserted postoperatively if the patient is unable to void spontaneously on two attempts muscle relaxant jaw pain purchase rumalaya gel with mastercard. Closed-catheter drainage after vaginal hysterectomy usually is not necessary for longer than 24 hours muscle relaxant norflex order generic rumalaya gel. The catheter is removed without clamping spasms film discount rumalaya gel 30gr visa, and there is no need to obtain a urine specimen for culture and sensitivity. Diet Although little manipulation of the bowel occurs during vaginal hysterectomy, there is some slowing of gastrointestinal motility. This slowing rarely occurs to a degree that limits some form of oral intake soon after surgery. Most patients experience some degree of nausea after surgery, which, combined with drowsiness from analgesics, usually makes them disinterested in food on the evening after surgery. A clear liquid diet is suitable during the first night after surgery, and on the first full postoperative day, a regular diet can usually be consumed. The patient is often the best judge of what she can tolerate as her appetite returns. Laparoscopic Hysterectomy Preoperative Preparation the main limitations to a laparoscopic approach are medical or anesthetic disorders that do not allow adequate pneuomperitoneum or proper ventilation (34). Extensive and dense pelvic abdominal adhesions from previous surgery and very large uterine size are relative contraindications, although this decision can be made after assessing the peritoneal cavity (see Chapter 23). If the uterine size limits access to the uterine vessels, laparoscopic hysterectomy may not be possible. Different classifications were proposed for the types of laparoscopic hysterectomy. The Cochrane review authors recommended that if the vessels are occluded laparoscopically, or if part of the operation is performed vaginally, the procedure be called laparoscopic hysterectomy, and, if no component is performed vaginally, the procedure should be called a total laparoscopic hysterectomy (41). Hyperflexion of the hips should be avoided because this may cause femoral nerve palsy. The patient should be placed on an egg crate mattress or beanbag cushion to limit patient movement in the Trendelenburg position. Shoulder braces should not be used as they are associated with brachial plexus injury. Instrumentation the most important instrument is the one used to occlude blood vessels. A multitude of energy forms exist, including electrosurgery, lasers, and ultrasonic scalpel (see Chapter 23). Some surgeons use stapling devices, although the cost of these stapling devices is high, and an energy-occluding device is needed to access areas that a stapler cannot. The versatility of the devices with energy makes them the method of choice to occlude vessels. There are no valid clinical data showing that one instrument is safer than another. The preferred one involves bipolar energy because gynecologists are experienced with this form of energy. Surgical Technique of Laparoscopic Hysterectomy Peritoneal Access the most important technical consideration for all laparoscopic surgery is port placement (se e Chapter 23). The umbilical site typically is used in patients without a previous history of surgery or intra-abdominal infection. In cases of previous surgery where there was a midline incision or a history of a pelvic-abdominal incision, an open laparoscopy is done or an alternative site is chosen to introduce the primary cannula. The standard closed technique involves the use of pneumoperitoneum needle (Verres needle), insufflation, and primary trocar insertion. An alternative technique is the direct trocar insertion (no insufflation prior to trocar insertion). If the left upper quadrant is used, the surgeon should be aware of the closest anatomic structures to the left costal margin (see Chapter 23, Fig. Typically the cannula is introduced below the left costal margin in the midclavicular line. The closest structures to this area are the stomach and the left lobe of the liver. Therefore, an oral gastric tube should be introduced to empty the stomach before starting the procedure. The patient is kept in a horizontal (not Trendelenburg) position until proper peritoneal access is confirmed. The angle of insertion of the primary trocar will depend on the size of the patient. Typically for nonobese or overweight patients a 45-degree angle from the horizontal is used and with obese patients a 60 to 80-degree angle or open technique is used. Proper placement of accessory ports is critical to allow the steps of a laparoscopic hysterectomy. The authors typically use three lateral accessory ports and do not use a suprapubic port. Lateral ports offer the surgeon an ergonomic approach in which both hands can be used comfortably. The most important step when placing lateral ports is to avoid the inferior epigastric vessels, which are branches of the external iliac artery and vein. These vessels (typically two veins and an artery) are seen through the peritoneum medial to the insertion of the round ligament in the deep inguinal ring. Ports are placed approximately 8 cm from the midline and 8 cm above the pubic symphysis. Laparoscopic hysterectomy requires traction and countertraction to identify the vascular pedicles and the ureter, which is accomplished with the uterine manipulator. The incision is carried anteriorly to create a bladder peritoneal flap by sharp dissection of the loose areolar cervicovesical tissue. The retroperitoneal space is opened and the ureter identified on the medial leaf of the broad ligament (Fig. The ovarian vessels (infundibulopelvic ligament) or the utero-ovarian ligaments are coagulated and transected, depending on whether the ovaries will be removed (Fig. The uterine artery is skeletonized by cutting the posterior peritoneum up to the uterosacral ligament, coagulated, and transected. The anterior dissection should be completed so that the bladder is completely off the anterior fornix area of the vagina (Fig. The uterus can be pulled out though the vagina or can be morcellated first, and then removed either vaginally or laparoscopically, whichever is easier. Intravenous indigo carmine is given and the integrity of the bladder and ureters confirmed with cystoscopy, if desired, by the surgeon. At the end of the procedure, the secondary ports should be removed under direct visualization to ensure that there is no bleeding. The fascia should be closed at port sites that are 8 mm or greater and smaller ports that have prolonged manipulation to avoid possible herniation. The patient is kept in the short stay unit and discharged within 24 hours if there are no complications. Side docking allows access to the perineum and vagina so that the assistant can comfortably manipulate the uterus. A robot-assisted hysterectomy goes through the same steps as a laparoscopic hysterectomy. A right-handed surgeon should have the monopolar scissors or harmonic scalpel through a right robotic port and a vessel-sealing device such as a bipolar instrument through a left-sided robotic port. If a fourth robotic arm is used, the additional port is placed on the right side for right-handed surgeons. Observational studies showed that outcomes for robotic-assisted hysterectomy can be similar to laparoscopic hysterectomy but with less blood loss and possibly fewer conversions to laparotomy (55,56). The learning curve to stabilize operative times for skilled laparoscopic surgeons is about 50 cases (57). Although these case series demonstrated equivalent operative times, an analysis of the Premier hospital database of over 36,000 laparoscopic or robotic hysterectomies demonstrated longer surgical times and higher costs with the robot-assisted procedures compared with conventional laparoscopy with little difference in perioperative and postoperative outcomes (58). Robotic-assisted laparoscopic hysterectomy is associated with delayed vaginal cuff dehiscence around 7 to 8 weeks after hysterectomy, although one case series showed an increased frequency with conventional laparoscopy (59,60). Laparoendoscopic Single-Site Surgery Another modification of laparoscopic hysterectomy is the introduction of laparoendoscopic single-site surgery or single-port surgery. Because some surgeons use one of the multiple ports at one site, laparoendoscopic single-site surgery is probably the best term. The role of single-site access to hysterectomy is unclear, and there are only case reports (61). Specifically designed umbilical port systems that admit multiple instrument access have enabled the development of this technique. The availability of flexible instruments and flexible tip laparoscopes allows the surgeon to perform a hysterectomy by reducing instrument crowding and clashing at the umbilicus. Intraoperative Complications: Laparoscopic Hysterectomy the intraoperative complications of a laparoscopic hysterectomy are similar to an open hysterectomy. Because there is an increased frequency of injury to the ureter and bladder, a cystoscopic evaluation after injection of intravenous indigo carmine dye is recommended (62). Intraoperative bleeding during a laparoscopic procedure is handled by use of a bipolar instrument. If it is not apparent where the bleeding is occurring, the procedure should be converted to an open one. Perioperative Care Many surgeons remove the bladder catheter at the end of the laparoscopic hysterectomy. Postoperative Complications of Hysterectomy A comprehensive discussion of postoperative complications after gynecologic surgery is presented in Chapter 22. Wound Infections Wound infections occur after 4% to 6% of abdominal hysterectomies (33). Measures believed to reduce the incidence of wound infections include a preoperative shower, no removal of hair, or if hair removal is necessary, removal of hair with clippers in the operating room, use of adhesive drapes and prophylactic antibiotics, and delayed primary closure (see Chapter 22). Incisional Pain Incisional pain can occur at trocar sites, especially if located in the region of the ilioinguinal or iliohypogastric nerves. Pfannenstiel incisions can be a source of chronic pain at the incision site as a result of nerve entrapment (63). Hemorrhage Immediately after hysterectomy, hemorrhage may become apparent in one of two ways. Bleeding from the vagina may first be noted by the nursing staff or physician within the first few hours after surgery. Second, the patient may be noted to have little bleeding from the vagina but deteriorating vital signs manifested by low blood pressure and rapid pulse, falling hematocrit level, and flank or abdominal pain. The first presentation is in the form of bleeding from the vaginal cuff or one of the pedicles. After vital signs are assessed, attention should be directed to the amount of bleeding. The patient should be taken promptly to the examining room, where the operative site is viewed using a large speculum and good lighting. If bleeding is not excessive, the vaginal cuff can be inspected, and in many instances, bleeding from the cuff edge will be found. Hemostasis can easily be achieved with one or two sutures placed through the mucosa. If bleeding is excessive or appears to be coming from above the cuff, or if the patient is too uncomfortable to tolerate adequate examination, she should be taken to the operating room. General anesthesia should be administered and the vaginal operative site should be thoroughly explored. Bleeding that is coming from above the cuff or is extremely heavy usually cannot be controlled through the vaginal route. An exploratory laparotomy is necessary to examine the pelvic floor, identify and isolate the bleeding vessel, and achieve hemostasis. The ovarian vessels and uterine arteries should be thoroughly inspected because they often are the source of excessive vaginal bleeding. If it is difficult to localize bleeding to a specific pelvic vessel, or if these maneuvers do not work, ligation of the hypogastric artery may be performed. In the patient with little vaginal bleeding in whom vital signs have deteriorated, retroperitoneal hemorrhage should be suspected. Hematocrit assessment, along with cross-matching of packed red blood cells, should be performed immediately. Diagnostic radiologic studies can be used to confirm the presence of retroperitoneal or intra-abdominal bleeding. The first is to give the patient a transfusion and follow serial hematocrit assessments and vital signs. In many instances, retroperitoneal bleeding will tamponade and stop, forming a hematoma that may eventually be resorbed. The risk with this approach is that the hematoma will become infected, necessitating surgical drainage. Once adequate exposure is obtained, the peritoneum over the hematoma should be opened and the blood evacuated. If bleeding is difficult to control, consideration should be given to unilateral or bilateral ligation of the anterior division of the internal iliac artery. Urinary Tract Complications Urinary Retention Urinary retention after hysterectomy is an uncommon occurrence. If the urethra is unobstructed and retention occurs, it is usually the result of either pain or bladder atony resulting from anesthesia. If a catheter was not placed after surgery, retention can be relieved initially with the insertion of a Foley catheter for 12 to 24 hours. If the patient still has trouble voiding and urethral spasm is suspected, success can be achieved with a skeletal muscle relaxant such as diazepam (2 mg twice a day). In most cases, waiting is the best course, and voiding usually occurs spontaneously. Ureteral Injury In patients who develop flank pain soon after vaginal hysterectomy, ureteral obstruction should be suspected. The incidence of ureteral injury is lower with vaginal hysterectomy than with abdominal hysterectomy (41,44). One risk factor for its occurrence is total uterine prolapse, in which the ureters are drawn outside the bony pelvis. The immediate step is attempted passage of a catheter through the ureter under cystoscopic guidance. If a catheter can be passed through the ureter, it should be left in place for at least 4 to 6 weeks, allowing sutures to absorb and the obstruction or kinking to release. If the catheter cannot be passed through the ureter, the best course is to perform abdominal exploratory surgery and repair the ureter at the site of obstruction. Vesicovaginal Fistula Vesicovaginal fistulas occur most often after total abdominal hysterectomy for benign gynecologic disease (50). Intraoperative steps to avoid the formation of a vesicovaginal fistula include correct identification of the proper plane between the bladder and cervix, sharp rather than blunt dissection of the bladder, and care in clamping and suturing the vaginal cuff. The development of a postoperative vesicovaginal fistula after hysterectomy is rare; the incidence is as low as 0. Patients who have a postoperative vesicovaginal fistula develop a watery vaginal discharge 10 to 14 days after surgery. Some fistulas resulting from surgery are noted as early as the first 48 to 72 hours after surgery. After vaginal examination with a speculum, the diagnosis can usually be confirmed with the insertion of a cotton tampon into the vagina followed by the instillation of methylene blue or indigo carmine dye through a transurethral catheter. If no staining occurs, the presence of a ureterovaginal fistula must be ruled out by the intravenous injection of 5 mL of indigo carmine dye. Within 20 minutes, the tampon should stain blue if a ureterovaginal fistula is present. If a vesicovaginal fistula is diagnosed, a Foley catheter should be inserted for prolonged drainage. Up to 15% of fistulas close spontaneously with 4 to 6 weeks of continuous bladder drainage. Waiting 3 to 4 months from the time of diagnosis before operative repair is recommended to allow reduction of inflammation and to improve vascular supply. After vaginal hysterectomy, the fistula site is above the bladder trigone and away from the ureters. The surgical correction is undertaken in a four-layered closure: the bladder mucosa, the seromuscular layer, the endopelvic fascia, and the vaginal epithelium.

As with abdominoplasty / apronectomy theses procedures are not routinely commissioned muscle relaxant benzo buy rumalaya gel 30gr visa. This is because purely removal of loose skin or excess fat irrespective of site on body is deemed to be cosmetic and does not meet the principles laid out in this policy spasms hamstring purchase genuine rumalaya gel on line. Liposuction Minimum Eligibility Liposuction (also known as liposculpture) is a surgical procedure performedto improve body shape by removing unwanted fat from areas of the body such Criteria as abdomen muscle relaxant shot for back pain generic rumalaya gel 30gr with visa, hips spasms diaphragm cheap rumalaya gel generic, thighs muscle spasms yahoo answers rumalaya gel 30gr line, calves spasms trapezius buy 30gr rumalaya gel with visa, ankles muscle relaxant pills purchase 30gr rumalaya gel with mastercard, upper arms spasms under sternum order 30gr rumalaya gel overnight delivery, chin, neck and back. This is because purely removal of unwanted fat from the above areas is deemed to be cosmetic and does not meet the principles laid out in this policy. Breast Augmentation Minimum Eligibility a) Breast Augmentation/enlargement involves inserting artificial implants Criteria behind the normal breast tissue to improve its size and shape. Breast Augmentation is not routinely commissioned, except for patients with breast cancer. This is because breast augmentation for non-cancer reasons is deemed to be cosmetic and does not meet the principles laid out in this policy. This is because breast augmentation on the breast not at risk of being affected by cancer reasons is deemed to be cosmetic and does not meet the principles laid out in this policy. However in some cases breast Page | 16 reduction surgery is necessary where large breasts impact on day to day life, for example ability to drive a car. Summary of intervention Breast reduction surgery is a procedure used to treat women with breast hyperplasia (enlargement), where breasts are large enough to cause problems like shoulder girdle dysfunction, intertrigo and adverse effects to quality of life. Surgery can be approved for a difference of 150 200gms size as measured by a specialist. This recommendation does not cover surgery for gynaecomastia caused by medical treatments such as treatment for prostate cancer. Page | 18 Breast reduction surgery for hypermastia can cause permanent loss of lactation function of breasts, as well as decreased areolar sensation, bleeding, bruising, and scarring and often alternative approaches. For women who are severely affected by complications of hypermastia and for whom alternative approaches have not helped, surgery can be offered. The applicability and predictive value of breast-related symptoms questionnaire in Page | 19 measuring breast-related symptoms pre and postoperatively. Mastopexy Policy Statement a) Mastopexy refers to the surgical correction of breasts that sag or droop. This can occur as part of the natural aging process, or pregnancy, lactation Page | 20 and substantial weight loss. This is because the procedure is deemed to be cosmetic and does not meet the principles laid out in this policy. This is because Mastopexy on the breast not at risk of being affected by cancer reasons is deemed to be cosmetic and does not meet the principles laid out in this policy. Guidance: Royal College of Surgeons Cosmetic Surgery Categorisation Weblink. Inverted Nipple Correction Policy Statement Nipple inversion may occur as a result of an underlying breast malignancy and it is essential that this be excluded. This policy explicitly relates to Page | 21 correction of inverted nipples for cosmetic reasons. This is because correction of inverted nipples is deemed to be cosmetic and does not meet the principles laid out in this policy. Surgery for Gynaecomastia Policy Statement Gynaecomastia is enlargement of the male breast tissue. This is because surgery for reduction of male breast tissue is deemed to be cosmetic and does not meet the principles laid out in this policy. Guidance: Royal College of Surgeons Cosmetic Surgery Categorisation Weblink. This is because there is a lack of research and clinical evidence to determine how effective this procedure is. This means there is no guarantee it will achieve a long-lasting desired effect, and there are short and long-term risks to consider. Therefore except where the criteria below is met surgery to reduce the size of the labia is deemed to be cosmetic and does not meet the principles laid out in this policy. Vaginoplasty Policy Vaginoplasty is a reconstructive plastic surgery and cosmetic procedure for the vaginal canal and its mucous membrane, and of vulvo-vaginal structures that might be absent or damaged because of congenital disease. This is because Vaginoplasty is deemed to be cosmetic and does not meet the principles laid out in this policy. Pinnaplasty Policy Statement Pinnaplasty is an operation to reshape the ears and make them less prominent. This can be done from the age of approximately 6 years depending on the thickness of the cartilage. This operation can be performed under local anaesthetic for adults but better under general anaesthetic for children. This is because there are no known links to high quality clinical guidelines/decision support tools for Pinnaplasty. On other occasions, when an earring is forcefully pulled the earlobe can split acutely. Repair is usually performed under local anaesthetic, is simple and repiercing is normally possible within a few weeks. Face Lift or Brow Lift (Rhytidectomy) Policy Statement A facelift, technically known as a rhytidectomy, is a type of cosmetic surgery procedure used to give a more youthful facial appearance. Facelifts are effectively combined with eyelid surgery (blepharoplasty) and other facial procedures a) Rhytidectomy is not routinely commissioned for cosmetic reasons. Rationale this is because there are many changes to the face and brow as a result ofageing that may be considered normal. However there are a number of specific conditions for which these procedures may form part of the reatment to restore appearance and function. Hair Depilation (removal) Policy Statement Hair depilation can be used for excess hair (hirsuitism) in a normal distribution pattern, or for abnormally placed hair. Page | 27 Hirsutism essentially means that an individual, usually female, grows too much body or facial hair in a male pattern. Hirsutism affects approximately 10% of women in Western societies and is commoner in those of Mediterranean or Middle Eastern descent. Rationale this is because all excess hair removal treatment that does not meet the criteria below is deemed to be cosmetic and does not meet the principles laid out in this policy. Guidance: British Association of Dermatologists hirsuitism patient information leaflet Weblink. Alopecia (Hair Loss) Policy Statement Treatment for Alopecia will not be routinely commissioned. This is because surgical treatment for hair loss is deemed to be cosmetic and Page | 28 does not meet the principles laid out in this policy. Spontaneous remission occurs in up to 80% of patients with limited patchy hair loss of short duration (< 1 year). Guidance: British Association of Dermatologists Guidelines for the management of alopecia areata (2012) Weblink. Removal of Tattoos/Surgical correction of body piercings and correction of respective problems Policy Statement Tattoo fading involves using a laser to target tattoo ink in the skin. The laser Page | 29 heats the ink particles, so they break up and allow the body to absorb them. Removal of Tattoos/Surgical correction of body piercings and correction of respective problems is not routinely commissioned. This is because surgical treatment for removal of tattoos/surgical correction of body piercings and correction of respective problems is deemed to be cosmetic and does not meet the principles laid out in this policy. It the intervention should only be offered in situations where the lesion is causing symptoms according to the criteria outlined below. Summary of Removal of benign skin lesions means treating asymptomatic lumps, bumps intervention or tags on the skin that are not suspicious of cancer. In certain cases, treatment (surgical excision or cryotherapy) may be offered if certain criteria are met. This policy does not refer to pre malignant lesions and other lesions with potential to cause harm. Rationale There is little evidence to suggest that removing benign skin lesions to improve appearance is beneficial. Though in certain specific cases as outlined by the criteria above, there are benefits for removing skin lesions, for example, avoidance of pain and allowing normal functioning. The effect of a dermatology restricted referral list upon the volume of referrals. Rationale this is because all removal of Lipomata that does not meet the criteria below is deemed to be cosmetic and does not meet the principles laid out in this policy. Treating scars Depending on the type and age of a scar, a variety of different treatments may help make them less visible and improve their appearance. Scars are unlikely to disappear completely, although most will gradually fade over time. If scarring is unsightly, uncomfortable or restrictive, treatment options may include: fi silicone gel sheets fi pressure dressings fi corticosteroid injections fi cosmetic camouflage (make-up) fi surgery It is often the case that a combination of treatments can be used. This is because Medical and Surgical treatment of Scars and Keloids that does not meet the criteria below is deemed to be cosmetic and does not meet the principles laid out in this policy. Botulinum Toxin Injection for the Ageing Face Policy Statement Botulinum toxin A is a powerful neurotoxin which is used medically to relax muscles and for certain conditions there are recognised clinical benefits to patients. Botulinum toxin injections, such as Botox, are used to help relax facial muscles and make lines and wrinkles less obvious. During the procedure, your skin is cleaned and small amounts of botulinum toxin are injected into the area to be treated. The injections usually take effect about three to five days after treatment and it can take up to two weeks for the full effect to be realised. This is because Botulinum Toxin Injection for the ageing face is deemed to be cosmetic and does not meet the principles laid out in this policy. Treatment for Viral Warts Policy Statement Warts are small lumps that often develop on the skin of the hands and feet. Treatment for Viral Warts is restricted to the minimum eligibility criteria below. This is because most plantar warts can be managed with over-the counter topical treatments or by treatments prescribed by your general practitioner. Treatment for Viral Warts that does not meet the criteria below is deemed to be cosmetic and does not meet the principles laid out in this policy. Guidance: British Association of Dermatologists Plantar Warts patient information leaflet Weblink. The vast majority affect healthy people, and most only have one spider angioma or a just a few. Spider angiomas may appear in certain conditions with increased levels of oestrogen hormones such as in pregnancy or when taking the oral contraceptive pill. This is because: fi In children and some adults, spider angiomas may go away on their own, which can take several years. This treatment is deemed to be cosmetic and does not meet the principles laid out in this policy. Guidance: British Association of Dermatologists Spider Angioma patient information leaflet Weblink. Rhinophyma (bulbous, red nose) Policy Statement Rhinophyma is a swelling of the nose. If the condition progresses, the nose becomes redder, swollen at the end and gains a bumpy surface which changes its shape. This swelling is because there is formation of scar-like tissue and the Page | 37 sebaceous glands (which produce oil on the skin) get bigger. Much more rarely, swellings can arise on other parts of their face such as the ears and chin. The condition is mainly seen in those who have rosacea, a rash that can affect the cheeks, forehead and nose (see rosacea leaflet for further information). However, although rosacea affects woman more than men, rhinophyma is seen mainly in fair-skinned men aged 50 to 70 years. This is because there is no cure for rhinophyma, although some treatments may control it. These treatments are deemed to be cosmetic and does not meet the principles laid out in this policy. Guidance: British Association of Dermatologists Rhinophyma patient information leaflet Weblink. Resurfacing Procedures: Dermabrasion, Chemical Peels and Laser Policy Statement Resurfacing procedures including dermabrasion, chemical peels and laserTreatment treatment are not routinely commissioned. This is because purely removal of surplus skin or fat irrespective of site on body is deemed to be cosmetic and does not meet the principles laid out in this policy. Guidance: British Association of Dermatologists Rhinophyma patient information leaflet Weblink. Other Cosmetic Procedures Policy Statement Cosmetic Procedures are not routinely commissioned. It is also important to note that revision of plastic surgery procedures originally Page | 40 performed in the private sector will not be funded. Referring clinicians should re-refer to the practitioner who carried out the original treatment. Back Pain Back pain is a common problem that affects most people at some point in their life. The pain can be triggered by bad posture while sitting or standing, bending awkwardly, or lifting incorrectly. Back pain is not generally caused by a serious condition and; in most cases; it gets better within 12 weeks. Chronic (persistent) pain develops in some cases and further treatment may then be needed. It is called nonspecific because it is usually not clear what is actually causing the pain. In other words, there is no specific problem or disease that can be identified as the cause of the pain. It may be triggered by bad posture while sitting or standing, bending awkwardly, or lifting incorrectly. In most cases, back pain will improve in a few weeks or months, although some people experience long term pain or pain that keeps coming back. Acupuncture Do not offer acupuncture for managing low back pain with or without sciatica. Criteria Spinal injections of local anaesthetic and steroid should not be offered for patients with non-specific low back pain. Page | 43 Epidurals (local anaesthetic and steroid) should be considered in patients who have acute and severe lumbar radiculopathy at time of referral. Psychological therapy Consider psychological therapies using a cognitive behavioural approach for managing low back pain with or without sciatica but only as part of a treatment package including exercise, with or without manual therapy (spinal manipulation, mobilisation or soft tissue techniques such as massage). Guidance: Royal College of Surgeons Commissioning guide: Low Back Pain: Broad Principles of the patient pathway (2013) Weblink. There is no clear definition but it is often defined as pain that has been present for more than 12 weeks. Apart from poor general physical health and disability there may also be depression, unemployment, and family stress. Radiofrequency and Endothermal Ablation for Chronic Back Pain Denervation of Lumbar Spine: Radiofrequency denervation should be part of comprehensive treatment by a multidisciplinary team. There should be ongoing assessment following a trial of treatment to show evidence of response. Repeat radiofrequency procedure may only be offered to those patients with a previous successful response (as above) if the benefits of the procedure lasted for at least 6 months. Therefore those patients who consistently experience less than 12 months relief following two radiofrequency procedures will not be offered further radiofrequency treatment. This is because few patients will need referral to secondary care, this is a high value part of the pathway hence the detail above (see Royal College of Surgeons Commissioning Guidance weblink below). Guidance: Royal College of Surgeons Commissioning guide: Low Back Pain: Broad Principles of the patient pathway (2013)Weblink. Page | 47 fi Treatment with spinal cord stimulation should only be given after the person has been assessed by a specialist team experienced in assessing and managing people receiving treatment with spinal cord stimulation. Hyperhidrosis can be challenging to treat and it may take a while to find the best treatment for you.

However spasms lower stomach order genuine rumalaya gel on line, in this manner tunnels must be created within the myometrium in order to extract distant fibroids spasms near belly button order rumalaya gel online, making hemostasis more difficult within these defects spasms 1983 buy 30gr rumalaya gel amex. Hemostasis is important in order to avoid adhesion formation muscle relaxer sleep aid generic rumalaya gel 30 gr without a prescription, and fibrin spasms of the bladder purchase 30gr rumalaya gel with mastercard, leucocytes infantile spasms 2 month old generic 30gr rumalaya gel amex, and platelets in the presence of erythrocytes leads to adhesion formation muscle relaxant oral discount rumalaya gel 30 gr with visa. If tunneling incisions are avoided and hemostasis secured immediately spasms video effective 30 gr rumalaya gel, the risk of adhesion formation should be lessened. Therefore, if incisions are made directly over the fibroids and only those fibroids that are easily accessed are removed, the defects can be promptly closed and hemostasis can be secured immediately (112). Multiple uterine incisions may be needed, but adhesion barriers may help limit adhesion formation (127). Laparoscopic Myomectomy Currently available instruments make laparoscopic myomectomy feasible, although the size and number of fibroids reasonably removed limits the wide application of this approach because of the technical difficulty of both the procedure and laparoscopic suturing (128). Although microprocessor-assisted myomectomy (robotic) may obviate some of these technical problems, the added cost and longer operating times associated with this approach must be considered (see Chapter 25). A systematic review of randomized controlled trials of laparoscopic versus open myomectomy included six studies with a total of 576 patients (129). Laparoscopic myomectomy was associated with longer operating times but reduced operative blood loss, less postoperative decline in hemoglobin levels, reduced postoperative pain, more patients fully recuperated at day 15, and fewer overall complications. Major complications, pregnancy rates, and new appearance of fibroids were comparable in the two groups. Case series without controls show the feasibility of laparoscopic surgery in women with large fibroids. In another series of 332 consecutive women undergoing laparoscopic myomectomy for symptomatic fibroids as large as 15 cm, only 3 women required conversion to laparotomy (131). Surgical Technique for Laparoscopic Myomectomy Port placement should be based on the position and size of the fibroids to be removed (Fig. A left upper quadrant approach may be used for initial access when uterine size is near or above the umbilicus (133). An incision is made directly over the fibroid and carried deeply until definite fibroid tissue and the avascular surgical plane is noted. The fibroid is grasped with a tenaculum for traction and the plane between the myometrium and fibroid is dissected until the fibroid is free. Bleeding vessels in the myometrial defect are desiccated sparingly with bipolar electrosurgical paddles, taking care not to devascularize the myometrium and interfere with wound healing. Delayed absorbable sutures are placed in one, two, or three layers, as needed, adhering to accepted surgical technique at laparotomy. Morcellation of the fibroid with an electromechanical device is accomplished under direct vision. The pelvis and abdomen are irrigated, the fluid suctioned, and an adhesion barrier may be placed. Although uterine and fibroid volumes decreased by approximately 50%, there were dense adhesions to the uterine serosa in 6 of 15 (53%) women undergoing subsequent laparoscopic evaluations for other reasons (135). Adhesions Following Myomectomy Adhesion formation after myomectomy is well documented (136). A Cochrane review found that Interceed reduced the incidence of adhesion formation, both de novo and reformation, at laparoscopy and laparotomy (137). During second-look laparoscopy, women treated with Seprafilm had significantly fewer adhesions and lower adhesion severity scores than untreated women. This study and others find an increased incidence of adhesions with posterior uterine incisions compared to anterior incisions (138). Hysteroscopic Myomectomy Submucous fibroids, sometimes associated with increased menstrual bleeding or infertility, often can be removed hysteroscopically. No meta-analysis of the association of submucous fibroids and abnormal uterine bleeding was performed. A study of 285 consecutive women with menorrhagia or metrorrhagia who had hysteroscopic resection of submucous fibroid(s) found that additional surgery was required for 9. Traction on fibroid and counter-traction on myometrium to tease fibroid away from myometrium. Monopolar electrodes require nonconducting distending solution (sorbitol 5%, sorbitol 3% with mannitol 0. The cutting loop is passed beyond the fibroid and cutting activated only when the loop is moving toward the surgeon and in direct view. Fibroids should be resected down to the level of the surrounding myometrium and, if fertility is desired, care should be taken to avoid excessive thermal damage to normal myometrium. Often, the remaining portion of the fibroid will be expressed into the uterine cavity by uterine contractions, allowing further resection. Fragments of fibroid are removed from the cavity with a grasping forceps or by capturing the fragments with the loop and extracting the telescope. The risk of perforation increases with deeper myometrial involvement of the fibroid (143). In some cases, repeat resection may be required after a few weeks, as the remaining portion of the fibroid is expressed into the uterine cavity by uterine contractions. Procedure-Specific Risks Cervical dilatation or insertion of the hysteroscope can cause uterine perforation, as can deep myometrial resection. Careful inspection of the uterine cavity should be undertaken to look for brisk bleeding or bowel injury. If no injury is apparent, the procedure should be terminated and the patient should be observed and may be discharged if stable (144). If a perforation occurs during activation of the electrode, then laparoscopy should be performed to carefully inspect for bowel or bladder injury. Fluid Absorption and Electrolyte Imbalance Intravascular absorption of distending media is a potentially dangerous complication that can result in pulmonary edema, hyponatremia, heart failure, cerebral edema, and even death (145). Careful monitoring of the fluid deficit is important and a fluid deficit of 750 mL during surgery should serve as a warning sign, with planned termination of the procedure. Many authors suggest termination of the procedure when the fluid deficit exceeds 1,000 mL, although other guidelines suggest termination after introduction of 1,500 mL of a nonelectrolyte solution or 2,000 mL of an electrolyte solution (145). Electrolytes should be assessed and corrected if necessary and diuretics considered. Risk factors for fluid overload include resection of fibroids with deep intramural extension or prolonged operating time. The use of normal saline combined with bipolar energy reduces the risk of hyponatremia, but a fluid deficit over 1,500 mL can lead to cardiac overload (146). Endometrial Ablation for Abnormal Bleeding Associated with Fibroids In selected women not desiring future childbearing, endometrial ablation with or without hysteroscopic myomectomy may be efficacious. Pad counts following ablation with or without fibroid resection found that 48 of 51 (94%) women had resolution of abnormal bleeding after a mean follow-up of 2 years (range, 1 to 5 years) (147). A study of 62 women followed for an average of 29 months (range, 12 to 60 months) found that 74% of the women had hypomenorrhea or amenorrhea, and only 12% required a hysterectomy (148). New Appearance of Fibroids Although new fibroids may sometimes develop following myomectomy, most women will not require additional treatment. If the first surgery is performed in the presence of a single fibroid, only 11% of women will need subsequent surgery (151). If multiple fibroids are removed during the initial surgery, only 26% will need subsequent surgery (mean follow-up 7. Sonography found that 29% of women had persistent fibroids 6 months after myomectomy (153). Additionally, the background formation of new fibroids in the general population should be considered. As previously noted, a hysterectomy study found fibroids in 77% of specimens from women who did not have a preoperative diagnosis of fibroids (4). Incomplete follow-up, insufficient length of follow-up, the use of either transabdominal or transvaginal sonography (with different sensitivity), detection of very small clinically insignificant fibroids, or use of calculations other than life-table analysis confound many studies of new fibroid appearance (154). Clinical Follow-Up Self-reported diagnosis based on symptom questionnaires has reasonably good correlation with sonographic or pathologic confirmation of significant fibroids and may be the most appropriate method of gauging clinical evidence of new appearance (22). One study of 622 patients ages 22 to 44 at the time of surgery and followed over 14 years found the cumulative new appearance rate based on clinical examination and confirmed by ultrasound was 27% (155) (Fig. An excellent review of life-table analysis studies found a cumulative risk of clinically significant new appearance of 10% 5 years after abdominal myomectomy (156). One hundred forty-five women, mean age 38 (range, 21 to 52), were followed after abdominal myomectomy with clinical evaluation every 12 months and transvaginal sonography at 24 and 60 months (sooner, with clinical suspicion of new fibroids) (153). However, no lower size limit was used for the sonographic diagnosis of fibroids and, thus, the cumulative probability of new appearance was 51% at 5 years. A study of 40 women who had a normal sonogram 2 weeks following abdominal myomectomy found that the cumulative risk of sonographically detected new fibroids larger than 2 cm was 15% over 3 years (157). Need for Subsequent Surgery Meaningful information for a woman considering treatment for her fibroids is the approximate risk of developing symptoms that would require yet additional treatment. A study of 125 women followed by symptoms and clinical examination after a first abdominal myomectomy found that a second surgery was required during the follow-up period (average 7. Crude rates of hysterectomy after myomectomy vary from 4% to 16% over 5 years (158,159). Prognostic Factors Related to New Appearance of Fibroids Age Given that the incidence of fibroids increases with increasing age, 4 per 1,000 woman years for 25 to 29-year-olds and 22 per 1,000 for 40 to 44-year-olds, new fibroids would be expected to form as age increases, even following myomectomy (17). Subsequent Childbearing the 10-year clinical new appearance rate for women who subsequently gave birth was 16%, but for those women who did not the rate was 28% (155). Number of Fibroids Initially Removed After at least 5 years of follow-up, 27% of women who initially had a single fibroid removed had clinically detected new fibroids and 59% of women with multiple fibroids initially removed had new fibroids (151). Laparoscopic Myomectomy New appearance of fibroids is not more common following laparoscopic myomectomy when compared with abdominal myomectomy. Eighty-one women randomized to either laparoscopic or abdominal myomectomy were followed with transvaginal sonography every 6 months for at least 40 months (160). Fibroids larger than 1 cm were detected in 27% of women following laparoscopic myomectomy compared to 23% in the abdominal myomectomy group, and no woman in either group required any further intervention. Therefore, many interventional radiologists advise against the procedure for women considering future fertility. Uterine Artery Embolization Technique Percutaneous cannulation of the femoral artery is performed by a properly trained and experienced interventional radiologist (164) (Fig. Total radiation exposure (approximately 15 cGy) is comparable to one or two computed tomography scans or barium enemas (165). A catheter is threaded to the uterine arteries and embolic material injected to block off blood flow to the uterus. Ten percent of women require readmission to the hospital for postembolization syndrome, characterized by diffuse abdominal pain, nausea, vomiting, low-grade fever, malaise, anorexia, and leucocytosis. Failure to respond to antibiotics may indicate sepsis, which needs to be aggressively managed with hysterectomy. Uterine Artery Embolization Outcomes the largest prospective study reported to date includes 555 women ages 18 to 59 (mean, 43), 80% of whom had heavy bleeding, 75% had pelvic pain, 73% had urinary frequency or urgency, and 40% of women had required time off work due to fibroid-related symptoms (166). Mean fibroid volume reduction of the dominant fibroid was 33% at 3 months, but improvement in menorrhagia was not related to preprocedural uterine volume (even >1,000 cm) or to the degree of volume reduction obtained. Within the follow-up period, 3% of women under 40, but 41% of women over 50, had amenorrhea. Loss of follicles might cause menopause at an age earlier than would otherwise be expected. Although the risk appears to be low for women younger than 40 years old, premature ovarian failure would be devastating in this setting. For women achieving pregnancy, one study reported that 6% had postpartum hemorrhage, 16% had premature delivery, and 11% had malpresentation (174). Another study reported eight term and six preterm deliveries, but two women had placenta previa and one woman had a membranous placenta. As a result, some authors recommend early pregnancy sonography to look for placenta accreta (175). Laparoscopic occlusion requires general anesthesia, is invasive, and requires a skilled laparoscopic surgeon. Transvaginal occlusion is performed by placing a specially designed clamp in the vaginal fornices and, guided by Doppler ultrasound auditory signals, is positioned to occlude the uterine arteries (178). The advantages of this procedure are a very low morbidity and a very rapid recovery, with return to normal activity in one day. Food and Drug Administration to approximately 10% of fibroid volume, and while a 15% reduction in fibroid size was reported 6 months following treatment, only a 4% reduction was noted at 24 months (180). More recent studies with larger treatment areas reported better results; 6 months after treatment, the average volume reduction was 31% (+/fi28%) (181). An evaluation of clinical outcomes 6 months after treatment found that 71% of women had significant symptom reduction, but at 12 months about 50% still had significant symptom reduction (180). One woman had a sciatic nerve injury caused by ultrasound energy and 5% had superficial skin burns. It remains to be seen whether increased treatment volumes will be associated with increased risks. Multiple treatment options usually exist and the following points might be considered. If the cavity is not deformed, fibroids need not be treated and conception may be attempted. If the cavity is deformed, myomectomy (hysteroscopic or abdominal) can be considered. An experienced laparoscopic surgeon may offer laparoscopic myomectomy, with a multilayered myometrial closure. For an asymptomatic woman who does not desire future fertility, observation (watchful waiting) should be considered. In the presence of very large fibroids, renal ultrasound or computed tomography urogram can be considered to rule out significant hydronephrosis. For a symptomatic woman who desires future fertility and her primary symptom is abnormal bleeding, baseline hemoglobin measurement should be considered because accommodation to anemia can occur. If indicated, further evaluation of the endometrium with endometrial biopsy can be performed. If the cavity is deformed, myomectomy (hysteroscopic or abdominal) should be considered. If the symptoms of pain or pressure (bulk symptoms) are present, and if the uterine cavity is not deformed, myomectomy (abdominal or laparoscopic) can be considered. For a symptomatic woman who does not desire future fertility, observation (watchful waiting) can be considered if no treatment is desired at that time. A symptomatic perimenopausal woman may desire observation until she enters menopause, when symptoms often diminish. Baseline hemoglobin measurements should be obtained and if a significant anemia exists, then treatment should be considered. If metrorrhagia is present, evaluation of the endometrium with sonography or endometrial biopsy should be considered. Myomectomy (hysteroscopic, abdominal, or laparoscopic), hysterectomy (vaginal, laparoscopic, or abdominal), or uterine artery embolization can be considered. For a woman with primarily fibroid-related pain or pressure symptoms (bulk symptoms), myomectomy, hysterectomy, and uterine artery embolization or focused ultrasound (presently limited by size and number of fibroids) may be considered. A new hypothesis about the origin of uterine fibroids based on gene expression profiling with microarrays. High cumulative incidence of uterine leiomyoma in black and white women: ultrasound evidence. Clonal determination of uterine leiomyomas by analyzing differential inactivation of the X-chromosome-linked phosphoglycerokinase gene. A comparative ultrastructural study of leiomyosarcoma, cellular leiomyoma, and leiomyoma of the uterus. Molecular pathogenesis of uterine smooth muscle tumors from transcriptional profiling. Sex steroid receptors in human myometrium and fibroids: changes during the menstrual cycle and gonadotropin-releasing hormone treatment. Immunohistochemical study of the proliferation index, oestrogen receptors and progesterone receptors A and B in leiomyomata and normal myometrium during the menstrual cycle and under gonadotrophin-releasing hormone agonist therapy. A prospective study of reproductive factors and oral contraceptive use in relation to the risk of uterine leiomyomata. Relationship of myoma cell size and menopausal status in small uterine leiomyomas. Variation in the incidence of uterine leiomyoma among premenopausal women by age and race. Risk factors for uterine fibroids: reduced risk associated with oral contraceptives. Effect of different doses of progestin on uterine leiomyomas in postmenopausal women. Postmenopausal estrogen and progestogen therapy and the risk of uterine leiomyomas. Protective effect of depot-medroxyprogesterone acetate on surgically treated uterine leiomyomas: a multicentre case-control study. Uterine leiomyomas express myometrial contractile-associated proteins involved in pregnancy-related hormone signaling. Childbirth and myoma treatment by uterine artery occlusion: do they share a common biologyfi

This is to be done in the preoperative area with the patient awake as a confirmation of accuracy muscle relaxant 2mg rumalaya gel 30gr otc. Failure to perform any of these steps increases the risk of performing the wrong operation on the wrong patient spasms when urinating order rumalaya gel 30 gr otc. The traditional use of checklists resulted in dramatic increases in the safety of aviation (41) muscle relaxant for children order 30 gr rumalaya gel visa. Their use in medicine is recent but is demonstrated to decrease complications significantly when used consistently to verify that procedural steps are not overlooked muscle relaxant in anesthesia order rumalaya gel online now. A simple five-step checklist for central-line placement in the intensive care unit was shown to reduce the incidence of catheter-related sepsis almost to zero (42 spasms near tailbone order 30gr rumalaya gel fast delivery,43) spasms during bowel movement cheap rumalaya gel 30 gr overnight delivery. Similarly muscle relaxants yellow order rumalaya gel from india, checklists are advocated for use in the surgical suite to ensure that critical steps for error prevention and patient safety are not overlooked muscle relaxant gi tract purchase discount rumalaya gel on line. It involves items to be reviewed and documented before the induction of anesthesia, before the skin incision, and before the patient leaves the operating room. The use of checklists such as this to improve patient safety in the operating room should become more widespread. The inadvertent retention of foreign bodies such as sponges, instruments, or other objects at the conclusion of surgery is a continuing source of patient harm. Risk factors associated with retained foreign bodies are emergency surgery, an unexpected change in surgical procedure, high patient body mass index, and failure to perform sponge and instrument counts (46). Systems must be established to prevent these occurrences, and surgeons need to aware of the contributing risk factors listed above (47). Strict adherence to guidelines for tracking surgical sponges is necessary to reduce the incidence of this serious complication. It involves standardized counting and recording of sponges at the start of the case and as additional sponges are added to the surgical field. At the conclusion of the surgery, all sponges are placed in special transparent holders to allow visual confirmation that all sponges were taken out of the patient. Other systems employ radiofrequency tagging of all sponges so that retained sponges can be detected easily before the surgical wound is closed (49). Some of the more sophisticated systems can check for errors and make suggestions based on preprogrammed guidelines and protocols. Avoiding abbreviations that may lead to medication error increases patient safety (51). Avoiding abbreviations that can be misread is an important and effective improvement, especially when orders are handwritten. It can be very dangerous for the written period to be missed, resulting in 1 mg being given to a patient rather than 0. Bar coding of medications improves error occurrence by reducing the rate of wrong medication by nearly 75%. Other types of medication error improvements attributed to bar coding include incorrect dose, wrong patient errors, and wrong time errors, which were reduced substantially through the use of bar coding (52). Disruptive Provider Behavior In 2009, as part of its accreditation standards, the Joint Commission proposed that all health care organizations with professional staffs develop and implement a Code of Conduct Policy along with an education program that addresses disruptive behavior. Disruptive physician (provider) behaviors include inappropriate conduct in the hospital setting, resulting in conflict or confrontation. These behaviors can range from verbal and even physical abuse to sexual harassment. In recent years disruptive behavior in the hospital setting has become more evident, if not more common. One study showed that the vast majority of surveyed physicians, nurses, and administrators had witnessed disruptive behavior by physicians (53). Nurses and other hospital employees also commit disruptive behavior, but it is far less common than disruptive physician behavior. Having an accepted and agreed-upon verbal process to question or suggest changes in patient management improves communication. Team building that encourages collegial interaction and a sense that all members of the health care team are important and have something to offer can promote a culture that makes disruptive behavior less likely. The program goal is designed to urge patients to take an active role in preventing health care errors by becoming involved and informed participants as members of the health care team. In 2008 a survey conducted by the Joint Commission indicated that campaigns like Speak Up add significant value to the accreditation process (54). Eighty percent of the more than1,900 organizations that responded rated the program as good or excellent. Studies show that greater patient (and family) involvement in health care decision making results in improved satisfaction and better outcomes (55). Patients and their families traditionally have low self-efficacy or confidence that they can understand and actively participate during their health care. Disclosure and Apology for Adverse Events Organized medicine is increasing its focus on the prevention of medical error. A controversial issue involving medical error is the need to promptly disclose and apologize for any medical errors that occur. In the past many, if not most, health care organizations focused on managing the medical legal risk of medical error. The conventional wisdom was that any disclosure and apology for error would lead to litigation and bigger payouts. The Joint Commission and other professional organizations require or endorse active disclosure to the patient when adverse events occur, including those caused by error (56). Three programs are worth noting in any discussion of disclosure and apology for medical error. The authors point out several fallacies about disclosure, including that disclosing medical error always leads to litigation and that error always means negligence. Lucian Leape, one of the fathers of the modern patient safety movement, pointed out that a patient has an ethical right to full disclosure of medical error (58). Although an apology is not an ethical right, it is a therapeutic necessity, according to Leape. Several programs are under way to test the assertion that disclosure and apology can decrease the likelihood of litigation. The Sorry Works Coalition, which is a coalition of doctors, insurers, and patient advocates, urges the use of full disclosure and apology for medical errors (60). They point out that the current tort system has failed, resulting in higher and higher malpractice premiums without decreasing the rate of medical error. Demands for caps on malpractice awards and greater disciplinary measures for providers are largely ineffective. The Sorry Works Coalition advocates early disclosure with apology and financial settlements without litigation as the way forward in dealing with medical error. Safety in the Office Setting Thus far, most efforts to improve safety involved activities that occur in the inpatient setting. This is a logical initial approach because most risky procedures and tests are performed in the hospital setting. There is a trend to adapt some invasive procedures and tests and offer them in the office setting. Gynecologic procedures such as hysteroscopy and loop excision of the cervix are examples of this. In addition to the task force and its report, the college developed a patient safety assessment tool and a certification process (61). The task force addressed issues of leadership in the office setting; competency and assessment; teamwork and communication; anesthesia safety; measurement (of processes and outcomes); and tools such as checklists, time outs, and drills. In the hospital setting, leadership for safety is provided at multiple levels, starting with the department chair, with assistance from designated personnel in risk management and quality assurance. In the office setting, this responsibility must be assumed by one individual in a solo practice and one or several in a group practice. One individual should be designated as medical director and his or her responsibilities are outlined in Table 3. The determination that a provider is qualified (credentialed) and competent to perform specific procedures (privileged) is equally important in the office setting. Procedures initially performed solely in an inpatient setting should be converted to the office setting only after the provider has demonstrated competency in an accredited operating room setting. Effective communication with office personnel and with patients was identified by the task force as an essential element for creating a culture of safety in the office setting. Regular meetings should be held with all office staff to establish and implement patient safety and quality improvement protocols. Anesthesia safety is critical for avoiding adverse outcomes in the office setting. As office based procedures become more invasive, many practices have incorporated certified anesthesia personnel into the office team. The level of anesthesia achieved, not the agents used, should be the primary issue regarding anesthesia safety. When nonanesthesia certified providers are managing the patient, appropriate credentialing and privileging should be documented. The task force strongly recommends the use of checklists, drills, and time-outs to verify the appropriate progress of office-based procedures. Verifying that the correct procedure is being performed on the correct patient during a time-out for confirmation is useful in the office setting, and drills and simulations are essential activities in high-reliability organizations. Advances in technology are expected to move many more invasive procedures into the office setting, and patients and providers will expect that these are performed with high-reliability and safety. The first is Office Safety Culture, which includes questions about patient identification, team training, and communication. The second is Practice Management, which looks at utilization of electronic health records or other systems to track patient appointments and inquiries, and reporting normal and abnormal diagnostic tests. Third is Medication Safety, which asks about practices related to accuracy of medication lists, medication prescribing, and the dispensing of drug samples. The last domain is Procedures, which evaluates the appropriateness of patient selection for office procedures, equipment availability and maintenance, and safe anesthesia practices. The various elements in these domains provide a roadmap for improvement in those office practices where physicians find they have not yet instituted some of these recommended features (61). The Business Case for Quality and Safety Given the evidence that supports efforts to improve the quality and safety of medical care, why is there still much work to do in this crucial areafi This means that there is no monetary reward for improving quality in medicine, and pursuing that goal will result in higher costs. How can the application of the quality and safety principles outlined above result in cost savings in the delivery of health carefi The business case for quality and safety is built on the concept of the elimination of waste in medical care. Brent James, executive director for the Institute for Healthcare Delivery Research at Intermountain Healthcare in Salt Lake City, identifies two main types of waste in health care (65). This is the failure to achieve the desired outcome of medical care the first time around. This would include such diverse events as medication errors that result in patient harm, hospital-acquired infections, wrong site surgeries, and retained foreign objects at surgery. This refers to excessive resource consumption to achieve an outcome when a different alternative is available to more efficiently achieve a similar outcome. An example would be performing an inpatient hysterectomy for menorrhagia that could be treated equally well with outpatient medication or endometrial ablation. James estimated that together these two sources account for as much as 50% of the expenditures on health care in this country (65). Combating these sources of wasted health-care dollars will require a widespread adoption of the principles discussed: the use of evidence-based medical treatments and safety technology; the elimination of unexplained clinical variation in our processes of care; improved teamwork and communication between providers in different disciplines; the direct involvement of patients and their families in monitoring their own care; and all of these under the guidance of committed health care leadership able to rally support for these efforts. The Dartmouth Institute found a strong correlation between higher health care quality and cost savings in multispecialty groups (66). In 2010, the Rand Corporation produced a technical report showing that improved patient safety, as measured by a reduction in adverse events at hospitals in California, resulted in a significant reduction in malpractice claims (67). This represents a large potential cost savings and is an attractive alternative solution to the problem of substantial malpractice costs in our current health care system. The twin aims of improving the safety and quality of the medical care are goals that all physicians should actively pursue. Resident duty hours: enhancing sleep, supervision and safety institute of medicine. Anesthesia crisis resource management: real-life simulation training in operating room crises. Effect of virtual reality training on laparoscopic surgery: randomized control trial. Geneva, Switzerland: World Health Organization Department of Communicable Disease, Surveillance and Response, 2002. Surgical safety checklist to reduce morbidity and mortality in a global population. The effect of computerized physician order entry on medication errors and adverse drug events in pediatric patients. Enhancing medication adherence through communication and informed collaborative choice. Liability costs before and after implementation of a medical error disclosure program. A mediation skills model to manage disclosure of errors and adverse events to patients. Executive summary of the American College of Obstetricians and Gynecologists Presidential Task Force on Patient Safety in the office setting. Physicians as leaders in improving health care: a new series in Annals of Internal Medicine. Appendix A: quality and inefficiency waste in the peer-reviewed medical literature. Higher health care quality and bigger savings found at large multispecialty medical groups. Cramer Clinical research includes a range of research disciplines and approaches, including patient-oriented research, clinical trials, epidemiology, and outcomes research. Patient-oriented research centers on understanding mechanisms of human disease, studies of therapies, or interventions for disease. Clinical trials use a controlled experimental design to assess the effectiveness of an intervention on an outcome. Epidemiology is the study of the distribution and determinants of health and disease in specific populations. Outcomes research and health services research include studies that seek to identify the most effective and efficient intervention, treatments, and services for patient care. Scientific validity of a research study is evaluated by understanding the study question, how the study was designed, and whether chance, bias, or confounding could have accounted for the findings. Study Designs Medical practice is evolving to include complex options for patient treatment and preventive care, in part because clinical research methods and techniques to guide patient care have advanced. To evaluate whether new treatments and diagnostic approaches should be integrated into clinical practice or decide whether observational data reported in the literature is relevant, clinicians should understand the fundamental strengths and limitations of clinical research methods and the level of evidence different types of studies provide. As outlined by the National Institute of Child Health and Human Development, clinical research includes patient-oriented research involving understanding mechanisms of human disease, studies of therapies or interventions for disease, clinical trials, and technology development. Epidemiologic methods and behavioral research are used in clinical research to examine the distribution of disease and the factors that affect health and how people make health-related decisions. Outcomes research and health services research include studies that seek to identify the most effective and efficient intervention, treatments, and services for patient care (1). The purpose of a research study is to test a hypothesis about and to measure an association between exposure (or treatment) and disease occurrence (or prevention). The type of study design influences the way the study results should be interpreted. Analytic studies are often subdivided into experimental studies (clinical trials) and observational studies (cohort studies, case-control studies, and cross sectional studies).

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