Trocar-guided total tension-free vaginal mesh repair of post-hysterectomy vaginal vault prolapse.
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ABSTRACT:
SUBMITTER: Milani AL
PROVIDER: S-EPMC2744794 | biostudies-other | 2009 Oct
REPOSITORIES: biostudies-other
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Project description:The treatment of post-hysterectomy vaginal vault prolapse (VVP) has been investigated in several randomized clinical trials (RCTs), but a systematic review of the topic is still lacking. The aim of this study is to compare the effectiveness of treatments for VVP.We performed a systematic review and meta-analysis of the literature on the treatment of VVP found in PubMed and Embase. Reference lists of identified relevant articles were checked for additional articles. A network plot was constructed to illustrate the geometry of the network of the treatments included. Only RCTs reporting on the treatment of VVP were eligible, conditional on a minimum of 30 participants with VVP and a follow-up of at least 6 months.Nine RCTs reporting 846 women (ranging from 95 to 168 women) met the inclusion criteria. All surgical techniques were associated with good subjective results, and without differences between the compared technique, with the exception of the comparison of vaginal mesh (VM) vs laparoscopic sacrocolpopexy (LSC). LSC is associated with a higher satisfaction rate. The anatomical results of the sacrocolpopexy (laparoscopic, robotic [RSC]. and abdominal [ASC]) are the best (62-91%), followed by the VM. However, the ranges of the anatomical outcome of VM were wide (43-97%). The poorest results are described for the sacrospinal fixation (SSF; 35-81%), which also correlates with the higher reoperation rate for pelvic organ prolapse (POP; 5-9%). The highest percentage of complications were reported after ASC (2-19%), VM (6-29%), and RSC (54%). Mesh exposure was seen most often after VM (8-21%). The rate of reoperations carried out because of complications, recurrence prolapse, and incontinence of VM was 13-22%. Overall, sacrocolpopexy reported the best results at follow-up, with an outlier of one trial reporting the highest reoperation rate for POP (11%). The results of the RSC are too small to make any conclusion, but LSC seems to be preferable to ASC.A comparison of techniques was difficult because of heterogeneity; therefore, a network meta-analysis was not possible. All techniques have proved to be effective. The reported differences between the techniques were negligible. Therefore, a standard treatment for VVP could not be given according to this review.
| S-EPMC5705749 | biostudies-literature
Project description:We present the rationale for and design of a randomized controlled superiority trial comparing 2 vaginal surgical approaches for the treatment of uterovaginal prolapse. The Study of Uterine Prolapse Procedures Randomized Trial (SUPeR) trial compares the efficacy and safety of native tissue repair with vaginal hysterectomy and suture apical suspension versus uterine conservation with mesh hysteropexy through 36 to 60 months postoperatively for primary repair of uterovaginal prolapse.The selection of the primary outcome measure, timing of randomization, patient and evaluator masking to surgical intervention, collection and adjudication of adverse events, cost effectiveness evaluations, partnering with industry, and surgeon certification of competency to perform the 2 procedures is described. A composite primary outcome of success defined as no prolapse symptoms, no objective prolapse beyond the hymen, and no retreatment of prolapse, with a minimum of 36 months postsurgery follow-up using survival analyses is planned. Secondary outcomes measured at baseline and every 6 months postsurgery include validated condition-specific and general quality of life assessments, global impression of improvement, body image, and sexual function measures. Unique challenges during the trial design include maintenance of patient masking to the intervention with routine gynecologic health maintenance and maintenance of evaluator masking.Recruitment and randomization of 180 participants is complete, and participants are currently in the follow-up phase.This trial will provide information to help surgeons counsel patients and contribute evidence-based information regarding risks and benefits of 2 approaches for the treatment of uterovaginal prolapse.
| S-EPMC4919185 | biostudies-literature
Project description:Vaginal vault suspension during hysterectomy for prolapse is both a therapy for apical insufficiency and helps prevent recurrence. Numerous techniques exist, with different anatomical results and differing complications. The description of the different approaches together with a description of the vaginal vault suspension technique used at the Department for Urogynaecology at St. Hedwig Hospital could serve as a basis for reassessment and for recommendations by scientific associations regarding general standards.
| S-EPMC4168537 | biostudies-other
Project description:ObjectiveThe objective of this study was to present the design of the Apical Suspension Repair for Vault Prolapse in a Three-Arm Randomized Trial (ASPIRe), which compares the efficacy and safety of 3 apical repairs: native tissue (NT) transvaginal repair, transvaginal mesh, and sacral colpopexy.MethodsPatient selection criteria, primary and secondary outcome measures including patient-reported outcome questionnaires, masking, surgeon certification, procedure standardization, adverse events collection and adjudication, and cost analysis will be described for this multi-centered randomized trial. Given the unique risks/benefits of each technique, a noninferiority design will be used to compare apical transvaginal mesh to mesh sacral colpopexy. A superiority design will be used to compare the 2 mesh repairs to NT transvaginal apical repair. Survival analysis will be used to assess a composite primary outcome for success composed of a subjective measure (no prolapse symptoms), objective measure (no prolapse beyond the hymen), and no prolapse retreatment, with a minimum follow-up of 36 months. Secondary outcome measures collected every 6 months include assessment of validated general and condition-specific quality of life measures, global impression of improvement, satisfaction and regret, body image, and sexual function.ResultsRandomization and surgical treatment of 360 participants are complete, and the study is in the follow-up phase.ConclusionsThis report will provide valuable insight on the design of a novel 3-arm surgical trial using mesh versus NT to repair vaginal vault prolapse. This trial will provide level 1 evidence on the risks and benefits of mesh augmented versus NT apical repairs.
| S-EPMC7326314 | biostudies-literature
Project description:ImportanceVaginal hysterectomy with suture apical suspension is commonly performed for uterovaginal prolapse. Transvaginal mesh hysteropexy is an alternative option.ObjectiveTo compare the efficacy and adverse events of vaginal hysterectomy with suture apical suspension and transvaginal mesh hysteropexy.Design, setting, participantsAt 9 clinical sites in the US Pelvic Floor Disorders Network, 183 postmenopausal women with symptomatic uterovaginal prolapse were enrolled in a randomized superiority clinical trial between April 2013 and February 2015. The study was designed for primary analysis when the last randomized participant reached 3 years of follow-up in February 2018.InterventionsNinety-three women were randomized to undergo vaginal mesh hysteropexy and 90 were randomized to undergo vaginal hysterectomy with uterosacral ligament suspension.Main outcomes and measuresThe primary treatment failure composite outcome (re-treatment of prolapse, prolapse beyond the hymen, or prolapse symptoms) was evaluated with survival models. Secondary outcomes included operative outcomes and adverse events, and were evaluated with longitudinal models or contingency tables as appropriate.ResultsA total of 183 participants (mean age, 66 years) were randomized, 175 were included in the trial, and 169 (97%) completed the 3-year follow-up. The primary outcome was not significantly different among women who underwent hysteropexy vs hysterectomy through 48 months (adjusted hazard ratio, 0.62 [95% CI, 0.38-1.02]; P?=?.06; 36-month adjusted failure incidence, 26% vs 38%). Mean (SD) operative time was lower in the hysteropexy group vs the hysterectomy group (111.5 [39.7] min vs 156.7 [43.9] min; difference, -45.2 [95% CI, -57.7 to -32.7]; P?=?<.001). Adverse events in the hysteropexy vs hysterectomy groups included mesh exposure (8% vs 0%), ureteral kinking managed intraoperatively (0% vs 7%), granulation tissue after 12 weeks (1% vs 11%), and suture exposure after 12 weeks (3% vs 21%).Conclusions and relevanceAmong women with symptomatic uterovaginal prolapse undergoing vaginal surgery, vaginal mesh hysteropexy compared with vaginal hysterectomy with uterosacral ligament suspension did not result in a significantly lower rate of the composite prolapse outcome after 3 years. However, imprecision in study results precludes a definitive conclusion, and further research is needed to assess whether vaginal mesh hysteropexy is more effective than vaginal hysterectomy with uterosacral ligament suspension.Trial registrationClinicalTrials.gov Identifier: NCT01802281.
| S-EPMC6749543 | biostudies-literature
Project description:The aim of the study was to compare the efficacy and safety of transvaginal trocar-guided polypropylene mesh insertion with traditional colporrhaphy for treatment of anterior vaginal wall prolapse.This is a randomized controlled trial in which women with advanced anterior vaginal wall prolapse, at least stage II with Ba ? +1 cm according to the Pelvic Organ Prolapse Quantification (POP-Q) classification, were randomly assigned to have either anterior colporrhaphy (n = 39) or repair using trocar-guided transvaginal mesh (n = 40). The primary outcome was objective cure rate of the anterior compartment (point Ba) assessed at the 12-month follow-up visit, with stages 0 and I defined as anatomical success. Secondary outcomes included quantification of other vaginal compartments (POP-Q points), comparison of quality of life by the prolapse quality of life (P-QOL) questionnaire, and complication rate between the groups after 1 year. Study power was fixed as 80% with 5% cutoff point (p < 0.05) for statistical significance.The groups were similar regarding demographic and clinical preoperative parameters. Anatomical success rates for colporrhaphy and repair with mesh placement groups were 56.4 vs 82.5% (95% confidence interval 0.068-0.54), respectively, and the difference between the groups was statistically significant (p = 0.018). Similar total complication rates were observed in both groups, with tape exposure observed in 5% of the patients. There was a significant improvement in all P-QOL domains as a result of both procedures (p < 0.001), but they were not distinct between groups (p > 0.05).Trocar-guided transvaginal synthetic mesh for advanced anterior POP repair is associated with a higher anatomical success rate for the anterior compartment compared with traditional colporrhaphy. Quality of life equally improved after both techniques. However, the trial failed to detect differences in P-QOL scores and complication rates between the groups.
| S-EPMC3824218 | biostudies-literature
Project description:Rectovaginal fistula caused by a tension-free vaginal mesh (TVM) is a rare condition. Moreover, a rectovaginal fistula is a challenging issue to address for surgeons regardless of causes. Due to a low rate of occurrence, treatment modality for a rectovaginal fistula caused by a TVM has previously received little attention. A successful surgery using several key techniques to address a rectovaginal fistula caused by a TVM is herein reported. A 78-year-old woman who underwent a TVM for a rectocele three months ago was referred to our hospital with a two-month history of anal bleeding. Mesh protruding into both the vagina and the rectum was confirmed. The patient was operated on under diagnosis of a rectovaginal fistula caused by TVM. TVM was removed by transvaginal dissection of the rectovaginal septum with division of both anterior and posterior arms of the TVM. Layer-to-layer sutures of rectal and vaginal walls were crossly performed with a drain placed in the rectovaginal septum after saline irrigation followed by a covering sigmoid colostomy. The wound healed without infection after surgery, and a water-soluble contrast enema demonstrated the healing of the rectovaginal fistula two months after surgery. No recurrent fistula was confirmed 15 months after stoma closure.
| S-EPMC6768818 | biostudies-literature
Project description:The outcome of post-surgical recurrences of cervical cancer may be improved through radiation dose escalation, which hinges on accurate identification and treatment of the target. The present study quantifies target motion during course of image-guided radiotherapy (IGRT) for vault cancers.All patients underwent planning CT simulation after bladder-filling protocol. A daily pre-treatment megavoltage CT was performed. All translations and rotations were recorded. Post-registration displacement of gross tumour volume (GTV) and centre of mass (COM) of GTV was independently recorded by two observers for fractions one to seven. Day 1 image sets served as reference images against which the displacements of COM were measured. We calculated the displacements of common volume (CV) and encompassing volume (EV) of GTV for both the observers.A total of 90 image data sets of 15 patients were available for evaluation. Individual patient GTV and average GTV by both the observers were comparable. The average shifts for EV were 2.4?mm [standard deviation (SD) ±1.2] in the mediolateral, 4.2?mm (SD ±2.8) in the anteroposterior and 4.0?mm (SD ±2.1) in superoinferior directions. Similarly, the average shifts for CV were 1.9?mm (SD ±0.6) in the mediolateral, 3.7?mm (SD ±2.7) in the anteroposterior and 4.4?mm (SD ±2.7) in superoinferior directions. Using Stroom's/van Herk's formula, the minimum recommended margins would be 4.5/5.2, 8.2/9.4 and 7.3/8.3?mm, respectively, for lateral, anteroposterior and superoinferior directions.Differential directional internal margin is recommended in patients undergoing IGRT for post-surgical recurrence of cervical cancers.Internal organ motion of vault cancers can be accounted for by a directional margin to the gross tumour.
| S-EPMC4730960 | biostudies-literature
Project description:OBJECTIVE:To retrospectively compare surgical success and complications between vaginal vault prolapse compared with uterovaginal prolapse in women who underwent apical prolapse repair for stage II-IV prolapse. METHODS:Women in one of three Pelvic Floor Disorders Network prolapse surgical trials were included. Absence of bothersome bulge symptoms, no prolapse beyond the hymen, and no subsequent prolapse treatment defined success and was our primary outcome. Secondary outcomes included comparison of quality-of-life measures, anatomic changes, and adverse events. Pelvic organ prolapse quantification (POP-Q) and quality-of-life measures were administered at baseline and 1-2 years postoperatively. Comparisons were controlled for study site, age, body mass index, baseline POP-Q, apical and anterior or posterior repair performed, and prior prolapse repair. Outcomes measured at multiple time points were analyzed using longitudinal models to assess whether differences existed across study follow-up. RESULTS:Four hundred twenty-one women underwent vault prolapse, and 601 underwent uterovaginal prolapse apical repair. The vault prolapse group was older, more likely to be white, and to have prior urinary incontinence or prolapse repair, stage IV prolapse, and more prolapse bother on a validated scale (all P?.034). The vault prolapse group was more likely to undergo sacrocolpopexy (228/421 [54%] vs 93/601 [15%]); the uterovaginal prolapse group was more likely to undergo vaginal repair (508/601 [85%] vs 193/421 [46%] P<.001). There were no differences in success (odds ratio [OR] 0.76 for vault prolapse vs uterovaginal prolapse, 95% CI 0.51-1.15, P=.20), changes in Pelvic Organ Prolapse Distress Inventory scores (-79.4 vs -79.8, P=.89), postoperative POP-Q point C measurements (-7.0 vs -7.1 cm, P=.41), or serious adverse events (86/421 [20%] vs 90/601 [15%], P=.86) between groups. Among women who underwent a vaginal approach for repair of vault prolapse (n=193) or uterovaginal prolapse (n=508), there were no differences in success rates (OR 0.67, 95% CI 0.43-1.04, P=.09) at 1-2 years postoperatively. CONCLUSION:Surgical success of stage II-IV vault prolapse and uterovaginal prolapse apical repair was similar whether performed vaginally or abdominally at 1-2 years postoperatively.
| S-EPMC5823764 | biostudies-literature
Project description:OBJECTIVES: To compare the effects of vaginal hysterectomy, subtotal abdominal hysterectomy, and total abdominal hysterectomy on sexual wellbeing. DESIGN: Prospective observational study over six months. SETTING: 13 teaching and non-teaching hospitals in the Netherlands. PARTICIPANTS: 413 women who underwent hysterectomy for benign disease other than symptomatic prolapse of the uterus and endometriosis. MAIN OUTCOME MEASURES: Reported sexual pleasure, sexual activity, and bothersome sexual problems. RESULTS: Sexual pleasure significantly improved in all patients, independent of the type of hysterectomy. The prevalence of one or more bothersome sexual problems six months after vaginal hysterectomy, subtotal abdominal hysterectomy, and total abdominal hysterectomy was 43% (38/89), 41% (31/76), and 39% (57/145), respectively (chi2 test, P = 0.88). CONCLUSION: Sexual pleasure improves after vaginal hysterectomy, subtotal abdominal hysterectomy, and total abdominal hysterectomy. The persistence and development of bothersome problems during sexual activity were similar for all three techniques.
| S-EPMC214074 | biostudies-literature