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01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Trials 1/2018

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

Zeitschrift:
Trials > Ausgabe 1/2018
Autoren:
Chunbo Li, Zhiyuan Dai, Huimin Shu
Wichtige Hinweise

Electronic supplementary material

The online version of this article (https://​doi.​org/​10.​1186/​s13063-018-2494-x) contains supplementary material, which is available to authorized users.

Abstract

Background

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.

Methods

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.

Discussion

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.

Trial registration

China Trial Register (CTR): ChiCTR-INR-15007408. Registered on 9 November 2015.
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