Dataset Information

Laparoscopic High Uterosacral Ligament Suspension vs. Laparoscopic Sacral Colpopexy for Pelvic Organ Prolapse: A Case-Control Study.

ABSTRACT:

Introduction

Laparoscopic 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 methods

In 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.

Results

Three 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.

Conclusion

Both 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.

SUBMITTER: Campagna G

PROVIDER: S-EPMC8930828 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Laparoscopic High Uterosacral Ligament Suspension vs. Laparoscopic Sacral Colpopexy for Pelvic Organ Prolapse: A Case-Control Study.

Campagna Giuseppe G Vacca Lorenzo L Panico Giovanni G Vizzielli Giuseppe G Caramazza Daniela D Zaccoletti Riccardo R Marturano Monia M Granese Roberta R Arcieri Martina M Cianci Stefano S Scambia Giovanni G Ercoli Alfredo A

Frontiers in medicine 20220304

<h4>Introduction</h4>Laparoscopic 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.<h4>Material and methods</h4>In the period from 2015 to 2018, 600 women were submitted to laparoscopic sacral colpopexy while 150 to laparoscopic high uterosacral ligament suspension in three ...[more]

PMID: 35308533

Similar Datasets

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: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.

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.

Dataset Information

Laparoscopic High Uterosacral Ligament Suspension vs. Laparoscopic Sacral Colpopexy for Pelvic Organ Prolapse: A Case-Control Study.

Introduction

Material and methods

Results

Conclusion

Publications

Laparoscopic High Uterosacral Ligament Suspension vs. Laparoscopic Sacral Colpopexy for Pelvic Organ Prolapse: A Case-Control Study.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets