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Laparoscopic inguinal ligament suspension versus laparoscopic sacrocolpopexy in the treatment of pelvic organ prolapse: study protocol for a randomized controlled trial.

ABSTRACT: Pelvic organ prolapse (POP) is a common health problem. The lifetime risk of undergoing surgery for prolapse is 11%. POP significantly affects the effects on quality of life and activities of daily living. Laparoscopic sacrocolpopexy (LSC) has been viewed as the gold standard treatment for women with POP who desire reconstructive surgery. However, LSC is associated with technical difficulties, resulting in a long learning curve and operative time. Recently, our team introduced a new laparoscopic technique of inguinal ligament suspension (LILS) and had confirmed its safety and efficacy in treating vaginal vault prolapse. As a new surgical technique for POP, a prospective randomized controlled trial comparing the LILS with the standard technique of LSC is necessary. Therefore, we will conduct a trial.The trial is a randomized controlled trial. It compares LILS with LSC in women with stage 2 or higher uterine prolapse. The primary outcomes of this study are perioperative parameters, including surgical time, blood loss, intraoperative complications, and hospital stay as well as surgical anatomical results using the pelvic organ prolapse questionnaire (POP-Q) classification at 6 weeks, 6 months, 12 months, and annually till 5 years after surgery. Secondary outcomes are subjective improvement in urogenital symptoms and quality of life, postoperative complications, postoperative recovery, sexual functioning, and cost-effectiveness at each follow-up point. Validated questionnaires will be used and the data will be analyzed according to the intention-to-treat principle. Based on an objective success rate of 90%, a noninferiority margin of 15%, and a dropout of 20%, 107 patients are needed in each arm to prove the hypothesis with a 95% confidence interval.The trial is a randomized controlled, multicenter, noninferiority trial that will provide evidence whether the efficacy and safety of LILS is noninferior to LSC in women with symptomatic stage 2 or higher uterine prolapse.China Trial Register (CTR): ChiCTR-INR-15007408 . Registered on 9 November 2015.

SUBMITTER: Li C

PROVIDER: S-EPMC5838885 | biostudies-other | 2018 Mar

REPOSITORIES: biostudies-other

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Laparoscopic inguinal ligament suspension versus laparoscopic sacrocolpopexy in the treatment of pelvic organ prolapse: study protocol for a randomized controlled trial.

Li Chunbo C Dai Zhiyuan Z Shu Huimin H

Trials 20180305 1

<h4>Background</h4>Pelvic organ prolapse (POP) is a common health problem. The lifetime risk of undergoing surgery for prolapse is 11%. POP significantly affects the effects on quality of life and activities of daily living. Laparoscopic sacrocolpopexy (LSC) has been viewed as the gold standard treatment for women with POP who desire reconstructive surgery. However, LSC is associated with technical difficulties, resulting in a long learning curve and operative time. Recently, our team introduced ...[more]

PMID: 29506566

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Project description:IntroductionLaparoscopic sacral colpopexy is the gold standard technique for apical prolapse correction but it is a technically challenging procedure with rare but severe morbidity. Laparoscopic high uterosacral ligament suspension could be a valid technically easier alternative using native tissue.Material and methodsIn the period from 2015 to 2018, 600 women were submitted to laparoscopic sacral colpopexy while 150 to laparoscopic high uterosacral ligament suspension in three Italian urogynecology referral centers. We enrolled women with apical prolapse stage ≥2 alone or multicompartment descensus. To reduce allocation bias, we performed a propensity matched analysis. Women undergoing laparoscopic high uterosacral ligament suspension surgery were matched 1:2 to women undergoing laparoscopic sacral colpopexy. The cumulative proportion of relapse-free women in time was analyzed by the Kaplan-Meier method. The primary objective of this multicenter case-control retrospective study was to compare the recurrence rate while the secondary objectives were to compare feasibility, safety, and efficacy of laparoscopic sacral colpopexy and laparoscopic high uterosacral ligament suspension in surgical treatment of pelvic organ prolapse.ResultsThree hundred and nine women were enrolled (103 laparoscopic high uterosacral ligament suspension; 206 laparoscopic sacral colpopexy). Median operatory time was significantly shorter in the laparoscopic high uterosacral ligament suspension group (P = 0.0001). No statistically significative difference was found in terms of estimated blood loss, admission time, intraoperative, and major early postoperative complications, postoperative pelvic pain, dyspareunia and de novo stress urinary incontinence. Surgical approach was the only independent risk factor for prolapse recurrence (RR = 6.013 [2.965-12.193], P = 0.0001). The objective cure rate was higher in the laparoscopic sacral colpopexy group (93.7 vs. 68%, 193/206 vs. 70/103, P = 0.0001) with a highly reduced risk of recurrence (RR = 5.430 [1.660-17.765]). Median follow up was 22 months.ConclusionBoth techniques are safe, feasible, and effective. Laparoscopic sacral colpopexy remains the best choice in treatment of multicompartment and advanced pelvic organ prolapse while laparoscopic high uterosacral ligament suspension could be appropriate for moderate and isolated apical prolapse when laparoscopic sacral colpopexy is not suitable for the patient or to prevent prolapse in women at high risk at the time of the hysterectomy.

Project description:Importance:Uterosacral ligament suspension (ULS) and sacrospinous ligament fixation (SSLF) are commonly performed pelvic organ prolapse procedures despite a lack of long-term efficacy data. Objective:To compare outcomes in women randomized to (1) ULS or SSLF and (2) usual care or perioperative behavioral therapy and pelvic floor muscle training (BPMT) for vaginal apical prolapse. Design, Setting, and Participants:This 2 × 2 factorial randomized clinical trial was conducted at 9 US medical centers. Eligible participants who completed the Operations and Pelvic Muscle Training in the Management of Apical Support Loss Trial enrolled between January 2008 and March 2011 and were followed up 5 years after their index surgery from April 2011 through June 2016. Interventions:Two randomizations: (1) BPMT (n = 186) or usual care (n = 188) and (2) surgical intervention (ULS: n = 188 or SSLF: n = 186). Main Outcomes and Measures:The primary surgical outcome was time to surgical failure. Surgical failure was defined as (1) apical descent greater than one-third of total vaginal length or anterior or posterior vaginal wall beyond the hymen or retreatment for prolapse (anatomic failure), or (2) bothersome bulge symptoms. The primary behavioral outcomes were time to anatomic failure and Pelvic Organ Prolapse Distress Inventory scores (range, 0-300). Results:The original study randomized 374 patients, of whom 309 were eligible for this extended trial. For this study, 285 enrolled (mean age, 57.2 years), of whom 244 (86%) completed the extended trial. By year 5, the estimated surgical failure rate was 61.5% in the ULS group and 70.3% in the SSLF group (adjusted difference, -8.8% [95% CI, -24.2 to 6.6]). The estimated anatomic failure rate was 45.6% in the BPMT group and 47.2% in the usual care group (adjusted difference, -1.6% [95% CI, -21.2 to 17.9]). Improvements in Pelvic Organ Prolapse Distress Inventory scores were -59.4 in the BPMT group and -61.8 in the usual care group (adjusted mean difference, 2.4 [95% CI, -13.7 to 18.4]). Conclusions and Relevance:Among women who had undergone vaginal surgery for apical pelvic organ vaginal prolapse, there was no significant difference between ULS and SSLF in rates of surgical failure and no significant difference between perioperative behavioral muscle training and usual care on rates of anatomic success and symptom scores at 5 years. Compared with outcomes at 2 years, rates of surgical failure increased during the follow-up period, although prolapse symptom scores remained improved. Trial Registration:clinicaltrials.gov Identifier: NCT01166373.

Project description:BackgroundSacrocolpopexy is the gold standard procedure for treating pelvic organ prolapse (POP) patients with apical defects. Different surgical approaches have emerged and been utilized successively, including traditional laparoscopy, single-hole laparoscopy, robotic laparoscopy, vaginal-assisted laparoscopy, and transvaginal approaches. Robotic sacrocolpopexy (RSC) has attracted increasing attention as an emerging surgical technique and has unique advantages, such as a "simulated wrist" mechanical arm and high-definition three-dimensional (3D) visual field, which has gradually begun to be utilized in the clinical setting.MethodsWe followed the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) reporting checklist, and a systematic literature search was conducted on six databases from their inception to 1st March 2020. We evaluated patients with POP who underwent RSC or laparoscopic sacrocolpopexy (LSC), outcomes (including perioperative outcomes: blood loss, operating times, blood transfusion, and hospital stay), surgery-related complications, as well as cure and recurrence rates.ResultsA total of 49 articles were available, including 3,014 patients, among which 18 were comparative studies on LSC vs. RSC, and 31 were non-comparative single-arm studies on RSC. For RSC, median operative time was 226 [90-604] minutes, estimated blood loss was 56 [5-1,500] mL, and hospital stay was 1.55 [1-16] days. Intraoperative complications and postoperative complications occurred in 74 (2.7%) and 360 (13.0%) patients, respectively. Of 2,768 RSC patients, 40 had been converted from a robot-assisted approach to other approaches, and 134 of 1,852 patients (7.2%) have recurrent prolapses of any compartment. Compared to LSC, RSC was associated with significantly lower blood loss and lower conversion rate. However, more operative time was observed in RSC. No significant differences were observed in perioperative transfusion, intraoperative and postoperative complications, or objective recurrence between RSC and LSC.ConclusionsRSC's application seems to contribute some advantages compared to conventional laparoscopic surgery, although both approaches appear to promote equivalent clinical outcomes. Notably, heterogeneity among studies might have affected the outcome of the study. Consequently, high-quality and large-sample randomized trials comparing both techniques are necessitated.

Dataset Information

Laparoscopic inguinal ligament suspension versus laparoscopic sacrocolpopexy in the treatment of pelvic organ prolapse: study protocol for a randomized controlled trial.

Publications

Laparoscopic inguinal ligament suspension versus laparoscopic sacrocolpopexy in the treatment of pelvic organ prolapse: study protocol for a randomized controlled trial.

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