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MRCOG PART 2 SBAs and EMQs

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Essay 331 - Gynae surgery

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		Posted by MR R. Sun Jul 25, 2010 08:10 pm
MR New surgical procedures are regularly introduced into gynaecological practice before good evidence for efficacy or safety is available. (a) Discuss the precautions that should be taken when introducing such procedures [10 marks]. Newer procedures lack long term safety and efficacy data and should be used carefully.If such procedures are being introduced this should be done under a research setting before widely available for the public.If unable to introduce it under trial setting there should be a national registry for maintaining datas and deriving results.Any patient who is undergoing such procedures outside clinical trails will be registered with this registry.Any complications arising around the procedure is reported to the registry/society.The clinician who is undertaking this procedure should specifically perform such related procedures with subspeciality interest.The patient should be aware of newer procedures and fully informed consent is obtained to perform the procedure.All the newer procedures should be guided by clinical governance.There should be appropriate training and continuing devepoment in terms of training.An audit national/local should be carried out to assess the outcomes and if any changes to be implemented.Clinical effectiveness and continuing improvements should be demonstrated.Appropraite risk management strategies should be in place and if any adverse event happens this should be used as \'learning from mistakes\' . (b) Discuss the information that should be provided to women undergoing mesh procedures for utero-vaginal prolapse [10 marks]. Health professional should explain that mesh procedures for uterovaginal prolapse is a recent development.It involves the use of bio- synthetic mesh to provide additional support to the tissues during th repair.This was derived from the idea of using mesh in hernia repairs.The procedure is usually cariied out under GA/Regional block and she will be able to speak to the anesthetist.The success rate of the procedure depends on the type of mesh used.The more commonly used type 2 meshes are reported to have high success rate compared to the traditional prolapse surgeries.However they are also associated with a failure rate lesser compared to traditional surgeries.The meshes are commonly used for recurrent prolapse or where a previous surgery has not yeilded any result.Being a foreign(synthetic) object to the body the mesh can be undergo rejection immediately.In a smaller percentage mesh erosion can happen after a few years with superficial erosion of the tissues and mesh being exposed through vaginal tissue or adjoining bladder and bowel.Though they have an elastic component sometimes after tissue healing they can be embedded very tight and can give rise to denovo dyspareunia.Adjacent bowel and bladder and blood vessel injury can happen during the operation.Cases of major blood vessel injury have been reported.There is also risk of infection and poor healing of the mesh.Denovo bladder(urgency,incontinenece) and bowel symptoms have been reported.There have been smaller reports where EUA & mesh removal had to be done due to persistent problems like unexplained bleeding and pain.The patient should be aware that there is an option of no treatment for her complaints.It should be explained that there are other alternatives for prolapse repair like tradiotional colprapphy,site specific prolase repair and pessaries.Long term for these are available and safety has been established.It should be explained to the patient that additional procedures like bladder,bowel reapir and resurgery might be required.I cases of excessive blood loss blood transfuion might be required and her consent should be obtained for the above.All the above explanations should be carried out if possible with diagramnatic representation.A leaflets containing all the information should be given to her.
		Posted by MR R. Sun Jul 25, 2010 08:10 pm
MR New surgical procedures are regularly introduced into gynaecological practice before good evidence for efficacy or safety is available. (a) Discuss the precautions that should be taken when introducing such procedures [10 marks]. Newer procedures lack long term safety and efficacy data and should be used carefully.If such procedures are being introduced this should be done under a research setting before widely available for the public.If unable to introduce it under trial setting there should be a national registry for maintaining datas and deriving results.Any patient who is undergoing such procedures outside clinical trails will be registered with this registry.Any complications arising around the procedure is reported to the registry/society.The clinician who is undertaking this procedure should specifically perform such related procedures with subspeciality interest.The patient should be aware of newer procedures and fully informed consent is obtained to perform the procedure.All the newer procedures should be guided by clinical governance.There should be appropriate training and continuing devepoment in terms of training.An audit national/local should be carried out to assess the outcomes and if any changes to be implemented.Clinical effectiveness and continuing improvements should be demonstrated.Appropraite risk management strategies should be in place and if any adverse event happens this should be used as \'learning from mistakes\' . (b) Discuss the information that should be provided to women undergoing mesh procedures for utero-vaginal prolapse [10 marks]. Health professional should explain that mesh procedures for uterovaginal prolapse is a recent development.It involves the use of bio- synthetic mesh to provide additional support to the tissues during th repair.This was derived from the idea of using mesh in hernia repairs.The procedure is usually cariied out under GA/Regional block and she will be able to speak to the anesthetist.The success rate of the procedure depends on the type of mesh used.The more commonly used type 2 meshes are reported to have high success rate compared to the traditional prolapse surgeries.However they are also associated with a failure rate lesser compared to traditional surgeries.The meshes are commonly used for recurrent prolapse or where a previous surgery has not yeilded any result.Being a foreign(synthetic) object to the body the mesh can be undergo rejection immediately.In a smaller percentage mesh erosion can happen after a few years with superficial erosion of the tissues and mesh being exposed through vaginal tissue or adjoining bladder and bowel.Though they have an elastic component sometimes after tissue healing they can be embedded very tight and can give rise to denovo dyspareunia.Adjacent bowel and bladder and blood vessel injury can happen during the operation.Cases of major blood vessel injury have been reported.There is also risk of infection and poor healing of the mesh.Denovo bladder(urgency,incontinenece) and bowel symptoms have been reported.There have been smaller reports where EUA & mesh removal had to be done due to persistent problems like unexplained bleeding and pain.The patient should be aware that there is an option of no treatment for her complaints.It should be explained that there are other alternatives for prolapse repair like tradiotional colprapphy,site specific prolase repair and pessaries.Long term for these are available and safety has been established.It should be explained to the patient that additional procedures like bladder,bowel reapir and resurgery might be required.I cases of excessive blood loss blood transfuion might be required and her consent should be obtained for the above.All the above explanations should be carried out if possible with diagramnatic representation.A leaflets containing all the information should be given to her.
		Posted by Bee N. Sun Jul 25, 2010 10:08 pm
New surgical procedures are regularly introduced into gynaecological practice before good evidence for efficacy or safety is available. (a) Discuss the precautions that should be taken when introducing such procedures [10 marks]. (b) Discuss the information that should be provided to women undergoing mesh procedures for utero-vaginal prolapse [10 marks]. (Bee) A) Patients undergoing new surgical procedure should be informed that the procedure is new and good evidence for efficacy or safety is not available. This will allow them to be properly informed before consent is given. Patients should be informed that feedback as to efficacy and complication both in the short and long term is encouraged for the purpose of clinical governance. Patient for the procedure should be carefully selected and those that may benefit from conservative treatment should be offered this in the first instance to reduce the number that will be unnecessarily exposed to the possible complications of the procedure. The surgeon performing the procedure should be adequately trained to perform it and ongoing training should be encouraged. New procedures should preferrably be performed by a surgeon appointed after training to do so as a subspecialty area of specialty. This will encourage increase in skill of that surgeon as more cases are done. It will also discourage surgeons who may not have opportunity to perform adequate number of cases from attempting the procedure. New surgical procedures should be done in either a research setting or under a clinical trial. Bodies/organisations should be established to maintain a register of patients who have had the procedure and in whom complications may arise both in the short and long term. Regular audit should be organised to ensure that the procedure is carried out as prescribed on the patients who actually need it. This may also help detect early the complications that result and the reason or associations of that complication. B)Women undergoing mesh procedures should be told exactly the name of the procedure and what type of mesh will be used. This is important as some patient may accept synthetic but may decline any biologically derived products especially allographs or xenographs. The patient should be informed about the proposed procedure and how it is carried out as full understanding of this is required for informed consent. They should also be informed about the anaesthesia that would be involved (general of regional) since some patients may prefer one or the other if a choice is given. The patient should also be informed of the benefits of having a mesh. Success rate of anterior or posterior colporrhaphy with mesh has been found to be slightly better than without mesh. The aim of the procedure should be clear to the patient ( reducing prolapse and/or avoiding hysterectomy when possible). Patient should be informed of the alternatives to the procedure such as pelvic floor exercises or non surgical traetment uch as use of ring and shelf pessaries. they should be informed that though success rate of these alternatives are lower than surgery with mesh, they have lower rate of complications. They should be informed that for mild forms of prolapse these non surgical treatments are more beneficial than in presence of severe forms of prolapse. They should be informed about the serious risks/complication associated with the procedure such as damage to surrounding organs such as bladder and bowel. Other less serious but more frequent risks include infection, bleeding, dyspareunia, tissue reaction to synthetic mesh and rejection, mesh erosion to the skin days to months post op. They should be informed about other procedures that may be carried out during mesh operation such as blood transfusion, repair of bowel or bladder since some may decline to such procedures as blood transfusion. Procedures that shouldnt be performed as instructed by patient should be documented. Being a new procedure patients should be informed information about that long term effect is not available and patient entered into a registry for collecting data about the procedure and whom it has been performed on. Patient should be encouraged to report any complication after the procedure and leaflets should be given for further infrmation.
		Posted by Penelope T. Mon Jul 26, 2010 12:57 am
a) New procedures should only be proposed if there is a sound scientific basis for success. New surgical instruments, devices, or products should preferentially be tested initially in animals prior to humans. New techniques should be tested in phased trials, initially in small groups of people and subsequently in larger populations. Any safety concerns should be highlighted and addressed prior to generalised introduction. Each patient involved should be counselled of the reasons for believing this technique\'s superiority over standard care, current lack of evidence, and trial basis, in addition to proposed possible side effects and complications. A fully informed consent should be obtained from each patient. The procedure should only be performed by specialists with expertise in that particular area, trained by the developers of the procedure, and able to deal with potential complications. Specialists should attend the necessary training prior to undertaking the procedure. Any staff involved (eg.scrub nurse) should also be trained. If specific devices are involved, a member of the device team may be present in theatre to assist with questions. Ongoing audit at a local and national level should be used to monitor success, failure, and complications. b) Women should be fully informed about the technique for their operation. They should be informed that the mesh used is non-absorbable and will remain in-situ. Success rates using mesh are superior in the case of anterior repair, although long term data is lacking. Posterior repair shows no significant difference in outcome so no benefit over conventional repair. Women should be informed of their general risks (including risks of the anaesthetic, UTI, DVT) and their specific risks. The latter include mesh infection (possibly chronic), mesh erosion (with a small risk of migration or need for removal with future surgery), and damage to bladder, bowel, urethra or blood vessels. They should also be informed about post operative pain and the chance of denovo dysparenuia. Any future surgery to remove mesh is likely to be more challenging.
		Posted by NIRMALA M. Mon Jul 26, 2010 01:31 am
Nirmala a. Before introducing any new procedure, ethical committee approval should be obtained. Good medline / Embase search should be done to find out any evidence about efficacy and safety. Definitive written methodology / steps to carry out the procedure should be implemented. Information leaflets should be prepared which explains about the procedure, probable risks and benefits. Procedure should be trained on a simulator module before trying on the patients if possible. It is safe for the patients if the procedure is done by the Senior Consultant experienced in the Specialty to begin with followed by Subspecialty trainees once the procedure is found to be safe and trainable by the Seniors. Operator should be thorough of the anatomy, anticipate any complications and react appropriately. Patients should be informed clearly that there is no evidence about the safety and complications related to this procedure. If the patient is willing to undergo the procedure then informed written consent should be obtained after explaining the procedure, benefits and risks involved with the procedure. Information leaflet should be provided to her. She should be informed that she needs to come for regular follow ups and need to report any complications that arise after surgery. All the details of the patients undergoing this new procedure should be entered in a new register. A separate team should be allocated for proper selection of cases, to perform the procedure, to follow up, to do proforma based auditing / research of outcomes as part of Clinical Governance. If any acute complication arise during per op or immediate post op, then appropriate steps should be taken by risk management team in order to avoid such complications in future. b. The woman should be explained that the uterus is dropping down from the normal anatomical position which may be associated with descent of bladder and rectum which is more pronounced under anaesthesia. She should be asked whether she had any surgeries for prolapse in the past, if so what type of surgery, whether she wants to retain uterus, is she sexually active?, tried any other form of treatment like pelvic floor exercises, pessaries, any presence of SUI or urge incontinence (should be diagnosed before any prolapsed surgeries). She should be explained that mesh surgeries are mostly done for recurrence of utero vaginal prolapse. Though the success rate is high with mesh repairs, complications are more with mesh surgeries. Other options should be discussed with the patient including conservative methods. She should be explained in simple words that depending on the presentation, anterior mesh to correct cystocele, posterior mesh to correct rectocele, total mesh which completely supports anterior vaginal wall, vault, posterior vaginal wall with or without hysterectomy depending on the patient’s wish. She should be explained that mesh is made of biological and synthetic variety and now-a-days, the synthetic variety is of use because of high graft rejection in biological varieties. She should be made clear of the complications pertaining to prolapse surgery in general like bleeding, infection, injury to bowel, bladder, ureter, urethra, retention of urine, de novo stress and urge incontinence, retention of urine, prolonged catheterization, need for intermittent self catheterization and all these complications are exagerrated in mesh repairs and comlications specific to mesh repair like erosion, prolonged hospital stay, bleeding per vaginum due to erosion and infection, recurrent urinary infection, dyspareunia in cases of posterior mesh repair, enterocele in cases of anterior mesh repair and resurgery to remove mesh in cases of severe complications. She should be explained that this procedure does not have any long term studies to explain safety and efficacy. It should be made clear that she understands all of the above clearly. Information leaflets should be provided to her. Consent form should be signed by her. She should be aware that she needs to inform any complications and need to come for regular follow up which will be studied for research and audit purposes.
		Posted by H H. Mon Jul 26, 2010 02:00 am
HHH Precautions regarding the new surgical procedure include those that are related to the surgical procedure , the patient , the surgeon, . The new surgical procedure should have been tried before in previous studies and showed efficiency ,despite this was not evidence based as not enough studies were done. Those who have tried it should have been from a well recognized medical research centre and studies published in well recognized journals. The patient should be aware that the procedure is a new one and despite being used and achieved success ,has not obtained good evidence for safety. Patients should know what the procedure entails, success rate, risks and benfits, and results of follow up. He/She should know that the surgery will be done by a trained and competent surgeon. She sould know that that the procedure is not yet approved or licensed. Consent should be taken. The surgeon should have been trained on the procedure in a centre which offer such procedure. He should audit his practice so as to improve his results and patient safety, and to reduce complication rate. He should get every help from paramedics and in case of involvement of a machine or apparatus,he can get help from the company producing it. The woman should know what the procedure involves and what the mesh is( material that is used to help reduce her prolapsed as in hernia repair). She is told that it has less failure rate and recurrence of prolapsed than other procedures such as conventional repair ,and that the mesh acts as a pillar to hold the prolapsed vagina with no removal of vaginal tissue. She is told of serious risks that can occur as infection, mesh erosion,and injury of bladder or rectum. She is told of the frequent risks as discomfort and pain, these can be relieved by analgesics. She is told of the alternatives to this procedure such as conventional repair but this would include removal of redundant vagina , sacrocolpopexy,but this will include an abdominal procedure, sacrospinous fixation and vaginal repair . She is told of additional procedures that can take place as repair of the bladder if injured and need for bladder catheter for 7-10 days, injury of rectum which might need a colorectal surgeon to repair and possibility of an abdominal stoma. She is told of the type of anesthesia she will have, usually general. She is shown the mesh ,which is usually a synthetic non absorbable type I mesh with large pores as it has high success rate. She can be shown a sketch or diagram of how it is applied , if the woman is anxious to know about it. Patient is told that it is a new surgical procedure with low failure rate but yet is not approved or licensed as no good evidence for efficacy and safety is yet available. She given written information and data that are now available for efficacy.
		Posted by Ir A. Mon Jul 26, 2010 02:52 am
New surgical procedures are regularly introduced into gynaecological practice before good evidence for efficacy or safety is available. (a) Discuss the precautions that should be taken when introducing such procedures [10 marks]. (b) Discuss the information that should be provided to women undergoing mesh procedures for utero-vaginal prolapse [10 marks]. a) Whenever a new surgical procedure is introduced, care should be taken that the procedure is performed by a team of surgeons who have some experience in doing it. The patient being offered the surgery should be explained about the intended benefits and advantages of the procedure. She should be informed that long term results are not yet available. All other possible alternative managements for which long term results are available should be discussed with her. Written information should be provided to the patients. This discussion should be documented in the case notes. Ideally new surgeries should be done in centres well equipped in dealing with any complications that may arise. Data must be collected meticulously and a careful record of success rates and complications must be made. An audit must be done and a regular review of the results of the surgery must be undertaken. New surgeries should ideally be performed as part of research settings with informed consent of the patients before being introduced in mainstream clinical practice. Cost effectiveness can then be assessed once the surgery is introduced on a larger scale. b) Women undergoing mesh procedures for for uterovaginal prolapse should be informed that mesh is used to reinforce the strength of the vaginal tissue. She should be informed about the type of mesh that will be used. Most frequently type I non-reabsorbable synthetic mesh is used. She should be informed that the success rate after surgery with mesh is higher as compared to surgical repair alone. The failure rate for anterior repair without mesh is about 30% which is reduced to about 9% when a nonreabsorbable mesh is used. The patient should be explained about the procedure of the surgery and how the mesh will be used. She should be explained about the risks of the surgery which include a 10% risk of mesh erosion. There is risk of infection of the mesh. She should be told about the risk of injury to surrounding organs ie bladder, bowel and ureter. Mesh erosion may necessiate repeat surgery for its removal. There is risk of de novo urinary incontinence with anterior repair and constipation and difficulties in defecation with posterior repair. There is also risk of dyspareunia in women undergoing prolapse repair with mesh. She should be provided written information.
		Posted by Chitra.s M. Mon Jul 26, 2010 04:08 am
A.New procedures should be offered in the context of clinical research when evidence for safety and/or efficacy of the procedure is not well established.The women undergoing the surgery should be informed that the data about risks and benefits is limited compared to established procedures.Women with previous failed surgeries and co-morbidities may not be good candidates for new surgery.The reasons for offering the new procedure should be documented and informed consent taken.The surgeon carrying out the procedure should have expertise in that particular area and should be competent to recognise and manage possible complications.Surgical team should be familiar with any new materials and instruments used.Pathways for short and long term follow up have to be in place for data collection so that sufficient safety and efficacy data can be gathered to guide the use of the procedure in future.Consideration should be given to establish a local/national registry where the complications and adverse outcomes can be reported.Ongoing audit has to be done to monitor the outcomes and complications of the surgery. B. The woman is explained that the procedure is aimed to relieve the symptoms of prolapse and improve her quality of life.The procedure involves the use of a mesh as a mechanical bridge between two structures(like uterus and sacrum).The different types of mesh like biological and synthetic ,their advantages and disadvantages are discussed.The surgery is done as an inpatient under regional or general anesthesia.She is informed about different procedures available like sacrohysteropexy and infracoccygeal sacropexy using nonabsorbable type 1 mesh.Procedure specific options of laparoscopy and laparotomy are discussed.These procedures allow preservation of uterus and menstrual function.However surgery is not a suitable option if further child bearing is planned.The procedure specific serious complications are discussed.Intraoperative complications include bleeding(requiring blood transfusion),injury to adjacent organs like bowel and bladder and additional procedures to repair these injuries.Post operative complications like denovo urinary symptoms (incontinence),denovo bowel symptoms are discussed.Long term complications would include denovo dyspareunia,mesh erosion and recurrence of prolapse.Other adverse effects like pain at operated site, infection and anaesthetic complications are discussed.She is informed about alternative surgical procedures(without mesh use) like abdominal/vaginal hysterectomy and Manchester repair .Concomitant surgery for anterior/posterior vaginal prolapse, stress incontinence is discussed as appropriate.The woman is told about non surgical options - pelvic floor exercises and use of pessaries.Written information is provided.
		Posted by A A. Mon Jul 26, 2010 04:09 am
AA a: These procedures should only be carried out by surgeons with special expertise. Procedure should be done under carefully controlled circumstances. Ideally they should be introduced under trial conditions, if it’s not possible should be introduced as part of registry. Strict governance should be employed in introduction of techniques and surgery. Procedure should be safe, effective and long lasting. They should be cost effective. They should be free of any morbidity and provide normalization of function with patient satisfaction and improvement of quality of life. Research should look for long term results and impact on quality of life. Written patient information should be available and arrangement for informed consent,including proposed procedures with intended benefits and risks. To separate serious from frequently occurring risks. Audit and clinical governance should be in place. b: Information should include about proposed procedure that is repair of prolapse by using mesh to add additional support for vagina and restore affected pelvic organ to their natural position and reduce risk of recurrence, particularly for recurrent prolapse. I will inform patient about nonsurgical including pelvic floor physiotherapy and use of pessaries (ring and shelf). These are short term symptomatic and not definitive treatments. Surgical procedure with and without mesh are available. Surgical procedures without mesh include hysterectomy, anterior and posterior coloporaphy without mesh and paravaginal defect repair. There is evidence that surgical repair using mesh may be more efficacious than repair without mesh. However data on efficacy and safety differ with different types of mesh and long term outcomes are not available. I will inform patient about different types of mesh. Biological and synthetic with absorbable and nonabsorbable materials. Patient may refuse biological mesh due to any religious believes. Absorbable synthetic mesh is not suitable for prolapse repair. I will inform her about the intended benefits to improve or resolve the symptoms of prolapse. Patient should also be informed about complications including damage to bladder, urethra, and bowel. There are 10% chances of mesh erosion with nonabsorbable synthetic mesh. There is a risk of urinary incontinence, bowel problems and painful coitus. Frequent risks are infection and hemorrhage. Procedure should be performed under GA or regional techniques according to patient wishes in liaison with anesthetist. Patient should be informed about Perioperative care and use of thromboprophylaxis according to risk assessment. Verbal information should be supplemented with written information leaflets from NICE and RCOG. Patient should be ensured that the final decision regarding her management will be according to her wishes.
		Posted by R v P. Mon Jul 26, 2010 04:52 am
a) Discuss the precautions that should be taken when introducing such procedures [10 marks]. Newer procedures in gynaecology surgery are essential for the advancement of the speciality and improving patient care. However it is paramout such procedures are evaluated with evidence in terms of efficacy, safety and long term outcome prior to offering such procedures to wider public. All new procedures should have been tried on models/ animals to establish safety. The next step should be to evaluate such procedures on volunteers in a research setting. Outcome data should be analysed in comparison to the exsiting gold standerd treatment ie - comparison of TVT with Birch colposuspension. Data from such evaluation should be peer reviewed. Ideally review by national bodies such as NICE technological appraisal for safety, efficacy and cost effectiveness should be sought. New surgical procedures should initially be performed by the experts in the relevent field. Appropriate training on models, cadavers is essential prior to using such procedures on patients. Surgical competency should be objectively assessed prior to operating on patients. All patients undergoing new surgical procedures should be entered to a registry. This should ideally be on a research setting.For example urogynaecologists have a national database on all surgical procedures. This allows audit outcomes both nationally and performance of individual surgeons. Training issues could also be identified by maintaining a registry. It also helps for long term follow up of patients. Prior to implementing any new surgical procedure in a hospital, local clinical governance committee should formally appraise the procedure and approve it. (b) Discuss the information that should be provided to women undergoing mesh procedures for utero-vaginal prolapse [10 marks]. Patients should be informed that mesh procedures are relatively new in the management of pelvic organ prolapse(POP). Therefore, long term data on safety efficacy and recurrance rates are lacking. With respect to apical prolapse, abdominal repair with mesh apper to have better success than vaginal sacrospinous fixation. This is from short term follow up data. Mesh erosion rates apper to be very low. This procedure also prevents dyspareunia. However the operation takes longer and the post operative recovery is prolonged. With regards to anterior compartment and posterior compartment surgery with mesh, data are very limited. There are few methods available such as Apogee Perigee and Prolift aiming to provide upper and middle support to vagina. Dysparaunia is a potential complication in sexually active women. Infection, bleeding and mesh erosion are other frequent complications. Serious complications include damage to bladder and bowel. Laparoscopic mesh repair is available in specialist centres for apical prolapse. Written information should be provied to help informed decision making. Women should be offered the opportunity to participate in any ongoing research and follow up studies.
		Posted by sonu P. Mon Jul 26, 2010 06:41 am
S a) The patients and professionals involved in care of such patients should be aware of lack of evidence based and consider it when counseling women for a particular surgical procedure. The health system should make sure that a commercial propaganda is not the only reason of change in practice. The local data about success and complication rate should be used during consent process. Only a trained healthcare professional should undertake the surgery and introduction of new surgical techniques should ideally involve the local clinical governance team in case of conflicts and litigation. A continued effort by an organization like NICE, to prove or disprove the benefits of the surgery should be present. A record of all the procedures, complications and outcome (short and long term) should be kept locally and informed to any regional or national registry. A local guideline/protocol should be available and a regular audit should be undertaken to assess practice against the standards. The professionals performing the procedure must try to keep up the skills by doing a certain number of procedures or attending refresher courses. b) The patient should be informed that this procedure is relatively new and long term data about the success, complications and overall outcome is limited. Also that there are no RCTs available and the evidence currently available is based on experience and good practice. A discussion about the different types of mesh and why a certain mesh is chosen over others in the given clinical circumstances. The benefits and risks of surgery like with or without the mesh should be discussed. She should be advised that few small studies have shown its role in preventing recurrence. There should also be a detailed discussion about the immediate and long term complications, e.g , infection, foreign body reaction dyspareunia, mesh extrusion, need for removal(type 2 mesh where antibiotics and macrophages can’t penetrate).
		Posted by zara A. Mon Jul 26, 2010 06:50 am
aThe introduction of new procedure require careful consideration because of concerns about patient safety and legal implications.The clinician carrying procedure will be responsible for procedure ,should make a proposel to hospital director and involve clinical governence.Clinician should include in proposel what is the procedure,how it will effect the already existing practice .What is the benefit of procedure.IS it approved by NICE.COST EFFECTIVEness should be established .Clinician carrying out procedure should be competent to do the procedure.THE financial implications should be considered.What complications can arise and how to manage them.THERE sould be asystem in place to report adverse incident.THE patient should be fullly aware that this is anew procedure ,serious and frequent risks should be explained and alternatives should be discussed ,informed consent should be taken.THere should be asystem in place to moniter the procedure .HOspital audit team should be involved and ensure arrange ment for regular audit.Patient should enter to risk register.THe other considerations are whether the traning of other staff involved in procedure require training.b]THE procedure offered depeds on her age,fertility wishes, coexistent cystocele,rectocele,incontinence.Patient should be made aware that the purpose of procedure is to correct the anatomical position of uterus and correct the anatomical defects in pelvic floor.It can be done abdominally laparotomy and laproscopically ,and vaginally.Uterus can be removed or retained depending on her fertility needs.THE procedure involves the use of non absorbable mesh .The advantages are that it reduces risk of recurrence of prolapse as compare to traditional procedures.The abdominal procedure[sacro hystero pexy ] is well established advantages are uterus can be retianed,less dyspareunia because of vaginal axis not disturbed .and functional length mantained risks are haemorrhage ,infection ,abdominal incision.mesh rejection,and will not correct rectocele..VAGINAL procedure involves removal of uterus and mesh place ment.[prolift,apogee],advantages are reduced operative time ,early mobility recurrence of prolapse is reduced .DISADVANTAGES are bladder injury ,bowel injury ,buttock pain ,mesh infection and erosion[10%],haematoma,anddyspareunia .VAginal procedure new long term data not available .ALTERNATIVE are vaginal hysterectomy with anterior and posterior repair ,pesaries .ANAESTHESIC consultation aranged .information leaf lets given.
		Posted by VINITA N. Mon Jul 26, 2010 05:25 pm
New surgical procedures are regularly introduced into gynaecological practice before good evidence for efficacy or safety is available. (a) Discuss the precautions that should be taken when introducing such procedures [10 marks]. (b) Discuss the information that should be provided to women undergoing mesh procedures for utero-vaginal prolapse [10 marks]. VV whenever a new procedure is being introduced, it should have the approval of a governing body like NICE or ethics comittee. It should be performed in a research setting by a person trained in the procedure. Patients should be given written information about the procedure. Patients should be explained clearly about the lack of sufficient data regarding efficacy and safety. They should be explained about the possible risks involved with the procedure. The surgeon should maintain a record of all the surgeries and regular follow up arranged to identity any complication and also efficacy of the procedure. Regular auditing is important to improve standard of care and efficacy of the procedure. B) Patient should first be explained what mesh repair is with verbal, pictoral representation and also by providing leaflet. She should be explained about the common complications that can occur like bleeding, infection, injury to bowel, bladder may occur during surgery. There is also possibility of urinary difficulties in the immediate post op period which may need prolonged catheterisation.She should be explained that there is risk of mesh erosion after a few years which may need further surgery to remove the mesh. There is also a risk of developing dyspaurenia following surgery. She should be assessed for risk of DVT and thromboprophylaxix should be discussed.
		Posted by Syamala H. Tue Jul 27, 2010 02:35 am
syamalah ansA: mesh repair had been introduced in pelvic organ prolapse surgery with out much clinical safety data and evidence of improved outcome.success of TVT in stress incontinence and excellent long term data on use of mesh in in abdominal sacrocolpopexy tempts the surgoen for its use in prolapse surgery. any new procedure should ideally be introduced under trial condition and if this is not possible then it should be introduced as a part of registery .in any circumstances it should be carried out only by gynecologist with special expertise in managment of pelvic organ prolapse. surgical expertise and training would require regular supervision and audit .stricter clinical governence is required in introduction of these technique. there should be proper arrangement of obtaining informed consent and suggested criteria for patient selection. procedure, its outcome including short and long term complication should be subjected to regular audit.ethical issues should be adressed by the ethical comittee and itscost effectiveness should be establised before it is introduced into general practise. ans B: patient should be informed about the type and extent of surgery intended depending upon her symptoms planned incision and effect on fertility. she should be informed about the lack of long term safety data associated with use of mesh use specially in anterior and post wall repair although data exists for abdominal sacrocolpopexy where useof mesh reduces the incidence of reccurrent prolapse. intended benefit is relief of symptoms and long term restoration of normal anatomy,improved bowel bladder and sexual fuction and aviodance of emergence of new surgery related symptoms.individual factors in her case which make her suitable canditate for mesh repair.factor like obesity previous surgery and comorbidity which can adversly effectthe outcome. also explain her about serious and frequent risk associated with surgery itself and additional risk that would be there due use of mesh itself.primary aim of introduction of mesh is to reduce the risk of recurrence but it is associated with risk of mesh extrusion which gets affected by factors like age of the patient,type of surgery(primary/ secondary) and concurrent hysterectomy.objective failure rate for anterior compartment defect without mesh is 29%,23% with synthetic absorbable mesh and 9% for nonabsorbable mesh. and there is no significant difference in objective failure rate for post compartment with or without mesh. additional complications other than mesh extrusion are denovo dyspareunia urgency urge incontinence and urinary retention. in post repair it can in addition cause constipation and difficulty in defaecation. extra procedures that may be required are bloodtransfusion, repair of bowel bladder and laprotomy. she should be told about alternative surgical procedure available and option of physiotherapy and pessary. additional procedure that should not be carried out without prior consent.she should be able to disccuss the type of anesthesia with the anesthetist. written information should be provided.
		Posted by Mohamed D. Wed Jul 28, 2010 03:19 am
Mohamed For any new procedure to be introduced a good evidence about safety and effacacy should be available before that. Good quality RCTs should be done before introduction into practice. The physiological process and effects of this practice should be well understood prior to introdution for humans. Physicains familiarity and understanding of the practice should be established beforehand. The long term efficacy and complications should be known prior to estaqblishment of such practice. After introduction into human practice , RCTs, and registery of cases with complications should be established for assessment of the procedure safety and efficacy. Patients should understand that such practice is aleady studied well, or still under trial and fully informed consent should be taken. Auditting of the results, and application of Clinical governance procedures to assess the new practice should be done regularly. Mesh procedures for vaginal prolapse has been recently introduced into practice after the success of TVT procedures for urinary incontenece. The NICE recmmends that it may be used for abdominal approach of repair for pelvic prolapse. She should be informed that long term results are not yet available and proper RCTs with good number of cases are not yet available.The mesh types avialble are the biological or synthetic materials. The former is associated with low erosion rates but inconsistent tissue strength which increse the recurrence rate and possibility of transmission of infection. The synthetic meshes are made from type I macroporous material, as same as TVT, which is associated with lower infection and fibrous tissue formation which decrease the possibility of recurrence. Complications are all from small RCTs and case studies, which include; buttock pain, vaginal erosion, bladder erosion, and serious infection. The procedure should be carried out abdominally, as the vaginal approach has less evidence and still needs trials. The procedure should be carried out by specialized gynaecologist with expertise in pelvic organ prolapse. Alternative procedures should be explained as surgical repair with high recurrence rate in 10 years follow up, but established and knows complication rates.
		Posted by Ida I. Wed Jul 28, 2010 03:30 am
I. A) Before introducing new procedures to be used on patients, approval has to be obtained by the Ethics Committee. Existing publications on the safety and efficacy of the procedure has to be reviewed carefully by a peer group committee. Patients need to be selected carefully. Thorough counselling on the nature of the procedure, benefits intended by doing the procedure, risks and complications that may arise need to done to obtain a valid consent. The patient should be informed that, although there has been recorded success with the procedure elsewhere, the evidence on the safety and efficacy is lacking. Written information and patient information leaflets should be provided for the patient. The patient\'s details need to be recorded into a registry. She has to be advised to come for regular follow up to assess any complications that may arise after the surgery. The surgeon has to be one with adequate or specialized training on the procedure. Any complications has to be recorded and managed appropriately as part of risk management. A clear guideline on the procedure has to be introduced by the department or Trust to minimise risk. Regular audits on the procedure, risks and complications, as well as surgeon competency has to be undertaken as part of risk management. B) Women undergoing mesh operations should be informed on the intended benefits of the procedure, which is for the treatment of utero-vaginal prolapse. They should be informed regarding the procedure, which is the insertion of a biological or synthetic sling through the vagina to reinforce the prolapse. She should be told of the different types mesh, which is biologocal or synthetic mesh. Biological mesh could either be allografts, which is are cadaveric in origin, or xenografts which is porcine in origin. Synthetic grafts can be absorbable or non absorbable. She shold be informed that biological mesh has lower erosion rates than synthetic, however it has a higher rate of infection. Conversely, synthetic mesh is more cost effective, but has a higher erosion rate. She should be informed that the procedure is permenant. Short term complications that commonly arise after the procedure are urinary tract infection, urinary retention that may necessitate self catheterization and bleeding that may require transfusion. Long term complications she may encounter are, among others, dyspareunia, scarring, narrowing of the vaginal orifice or recurrent prolapse. She should also be informed regarding mesh erosion or damage to the urethra, bladder or bowel may require further surgery. The type of anaesthesia that may be used during the surgery needs to be informed to her. She should also be advised to avoid heavy lifting (more than 10 kgs), weight gain and smoking postoperatively as it increases the risk of failure. Written information and patient information leaflets should be given.
		Posted by Kiran J. Wed Jul 28, 2010 03:48 am
New surgical procedures are regularly introduced into gynaecological practice before good evidence for efficacy or safety is available. (a) Discuss the precautions that should be taken when introducing such procedures [10 marks]. (b) Discuss the information that should be provided to women undergoing mesh procedures for utero-vaginal prolapse [10 marks]. (a) It is pertinant that such procedures are introduced under a research setting and registered to a research registry.The plan ,protocol,design and methadology along with its benefits and possible complications should be reviewed by the ethics committe,should be scientifically valid and in keeping with the National research governance framework. Patient should be informed about the procedure and an informed consent should be taken.Pictorial information in the form of leaflets and charts should be provided for procedure information.Patients should be informed that it is a new procedure and lacks data on its long term efficacy or safety. Arrangements should be made to sagegaurd a personwho lacks capacity to consent under mental capacity act 5. The dignity,safety and well bieng of the patients should be a priority. The procedure should not cause any harm to the patient and the benefits of the procedure should outwiegh the possible side-effects. If complications are more than benefits resulting from the procedure than procedure and research should be abandoned. The procedure should be carried out by a professional experienced in the task and subspecielity.He/she should ensure that the procedure is carried out in accordance to the pre-set protocol and report any adverse event.It is essential that the confidentiality of medical records and data generated from the procedure under view be maintained by everyone involved in patient care. (b) Women should be informed that these procedures lack clinical safety data and long term benefits as compared to the traditional suturing techniques.They do have a role in women with recurrant prolaspe and connective tissue disorders.The procedure employs the use of the Type one monofilament and macroporous mesh which is theoretically the best type of implant. She would be informed that the procedure involves placement of a mesh at the area of prolapse to provide additional support.She should be informed that the procedure is done under General/regional anaesthetic and that she will have a chance to discuss this with the anethetist. Information is given regarding short term and longterm complications.Immediate post op she may experience pain,decreased mobilization and difficulty urination/defecation.There are risks of infection due to hospital stay and secondary to procedure it self and risk of venous thromboembolism due to decreased mobilization.She should be informed regarding risk of mesh extrusion the rate of which may be increased in cases of advanced patient age,secondary repair of relative inexperience of the surgeon. There is a risk of failure of the procedure and recurrance. Apart from this ,other complications are denovo dysparunia,urgency,urge incontinance and urinary retention for anterior prolapse mesh placement .For posterior mesh placement there are risks of dyspaunia and constipataion difficulty defecation. She shouls be informed about recovery period of about 6 -8 weeks and follow up in clinic to be reviewd after the procedure.
		Posted by Aruna R. Wed Jul 28, 2010 03:53 am
aruna New surgical procedures are regularly introduced into gynaecological practice before good evidence for efficacy or safety is available. Discuss the precautions that should be taken when introducing such procedures [10 marks]. I will do literature search to find out the available information about the procedure and analyse is it really needed for the available population. Are there any better alternatives and weigh the benefits against the risks. Before introducing the procedure I will make sure that who is going to do it and whether that person has got adequate training and competency to do it.I will discuss it with the trust committee involving the clinical and medical directors. I will make a business plan and get it agreed by concerned people.The theatre staff and the assistants need proper training. I will make sure the necessary equipments are available for the procedure. This should be started as a pilot programme or as a research project. I will make a proper written information leaflet and a separate consent form. I will make patient selection criteria for this procedure and care fully select patients according to it. I will get informed consent and I will make extra time in the theatre list to deal with unexpected problems. There should be plan for follow up and audit the service after certain time toassess the performance. ((b) Discuss the information that should be provided to women undergoing mesh procedures for utero-vaginal prolapse [10 marks]. I will explain the procedure well and also by whom, where, and when the procedure is going to be performed. The national and the local success rates of the procedure are given to her. The performance of the unit which is regularly audited and proved results are given to her. The possible risks including infection, bleeding, injury to bladder or bowel, tape erosion and recurrence. Narrowing of vagina may lead to dysparunia. Backpain and buttock pain are associated with some tape procedures. I will explain about the mesh (absorbable and non absorbable) and reassure her it will not cause allergic reaction. The long term out comes are not yet established. The short term outcomes are available and it should be well explained to her. The length of hospital stay and the need for catheterisation till she recovers, are clearly explained to her. The need for assessment for thromboprophylaxis and to teach her to get the self injection are explained. The type of anaesthesia and its complications are explained by anaesthetist. Written information about the procedure should be given. I will give her the post operative advice (avoiding sex, car driving for 6weeks) and the need for pelvic floor exercise. The need to attend the post operative follow-up appointment at 6weeks. The need for signing the consent should be told to her. The detail of the consultation documented in her notes.
		Posted by Bgk H. Wed Jul 28, 2010 07:38 am
bgk a. New surgical procedures need to be performed for the patient best interest. To introduce a new method, good evidence and reliable publications should be considered. Evidences based on Cochrane review and randomized control trial should be deemed reliable. However the population and expertise involved in the patients need to be quite similar to the population in the study. Before the introduction of a new procedure, a team involving surgeon, theatre nurses and anesthetists should have a meeting regarding the intended procedure and a joint decision should be obtained whether it is suitable and acceptable to be performed. An appropriate training should be given before the procedure. A continuous audit should be done. Any identified complication should be documented and be discussed. Proper patient selection should be done and high risk patient should be identified. Patient should be aware regarding the new procedure and informed regarding the possible complications. Consent from the patient regarding the new procedure should be obtained and documented. b. I will inform her that this involve putting a net like structure in addition to normal uterovaginal prolapse procedure. This is intended to strengthen the support of the structure. And there is some evidence showing a benefit. I will inform her regarding the risks of the procedure. This includes difficulties on placement of the mesh. Early complications include pain morbidity; injury to other organ such a urinary bladder or rectum should be informed. Later complication includes infection of the mesh and it may displace and migrate to other places. Post op expectation such as indwelling catheter should be informed and urinary retention may occur following removal of the catheter after the procedure. Any other options should also be informed such as tying both sides of uterosacral ligament. Different types of mesh used and the advantage and disadvantages of every type should be informed. A realistic success rate of the procedure according to the center records should be given. Patient decision of the procedure should be clearly recorded and documented. A written patient information sheet should be given.
		Posted by I M. Thu Jul 29, 2010 12:14 am
Their should be some evidence of benefit of procedure and ideally should be introduced in the setting of trial.The new procedure is likely to lack evidence of success and complications. Many unforeseen side effects or complications may be seen afterwards .the procedure should be introduced if it is likely to have better success rate than existing procedure ,shorter operation time ,ls simpler, easy to learn, likely to have low complication rate . Before introducing to clinical practice adequate training is given to surgeons and certain level of competency is reached before performing on patients. Surgery should be performed by the surgeons who will be able to manage the complications arising as a result of procedure. . Auditable standards are set and regular audits are carried out at the personal and institutional and national level. The procedure is withdrawn if unacceptable complications , side effects of procedure or low success rate are found. The procedure should be cost effective .Adequate realistic information is provided to the patient, she is informed its newer procedure ,less is known about the success rates ,benefits and complications. Patient information leaflet is prepared before its introduced in clinical practice. b; Patient is informed that it is relatively new procedure ,the aim of the procedure is to support vagina and restore pelvic organs in their original position. It involves putting a mesh to strengthen the pelvic floor under adequate analgesia which may be general or regional. evidence suggest it may work better than traditional procedures. She should be informed long term safety data success rate ,and complications is not available. Existing data suggests reduced recurrence rate, of prolapse than traditional non mesh procedures at short term long term data unavailable.she should be given information about complications like mesh erosion rate 5-12% depending upon the type of mesh used,new onset urinary incontinance 1-5%.dusparunia rate of 63% with posterior repair.there is risk of infection vaginal narrowing.rare complication of fistula formation.the success rate is above 90%.she should be informed she may need re operation in 13% of cases.she should be informed about recovery time which is shorter in vaginal procedures compared to abdominal procedure.she should be given information about alternative procedures and that she may opt out of procedure .she should be given information about the contact pathways if any complication develops.and informed about the followup after procedure.
		Posted by A- N. Thu Jul 29, 2010 04:03 am
Before introducing new procedures, its efficacy,adverse effects, camparison with old procedures should be studied. This in the form of resaearch, trial or short study can be done to find out about success rate of the procedure, potential complications and safety of the proicedure before introducing into the unit. There should be appropriate guidelines and protocols for these procedures including inclusive and exclusive criteria. These are difficult procedures and requires expertise and therefore training in these procedures and regular updates are required to keep these procedures safe. This training should be monitored by regulatory bodies as RCOG. An information leaflet should be available to patients outlining, risks, befnifits, potential complications, other procedures available. National and local registrars should be maintained to enter the when these procedures are undertaken to identify the efficy, failure rates and complications of these procedures if undertaken nationally. The procedure should be subjected to regular audits so that best practice can be undertaken, with respect to guidelines. B) The patient should be informed that these procedures have better success rate than the traditional methods where mesh is not used. These are difficult procedures. Inform her regarding, no evidence available on long term effect of these procedures. Explain her the risks of mesh erosion may require repeat operation later. Once the mesh is put, its permanent and the mesh cannot be removed. It is important to mention about effect on quality of life due to dyspaerunea because of mesh erosion, she will require appropriate followup and may need to be entered into national registrar. This is required as these procedures are relatively new and if any alterations need to be done in future. We should advise her when to seek medical help if any complecations arise.