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Published in: Trials 1/2020

Open Access 01-12-2020 | Study protocol

Self-cut titanium-coated polypropylene mesh versus pre-cut mesh-kit for transvaginal treatment of severe pelvic organ prolapse: study protocol for a multicenter non-inferiority trial

Authors: Juan Chen, Jiajie Yu, Abraham Morse, Christian Fünfgeld, Kuanhui Huang, Jian Gong, Guangshi Tao, Binan Wang, Yuling Wang, Xiangyang Jiang, Gulina Ababaikeli, Peishu Liu, Hatiguli Nisier, Xiaowei Zhang, Ping Wang, Xin Sun, Lan Zhu

Published in: Trials | Issue 1/2020

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Abstract

Background

Pelvic organ prolapse (POP) is a common health problem and has significant negative effects on a woman’s quality of life. The transvaginal mesh procedure is a durable reconstructive surgery, but the mesh kits are expensive for underdeveloped countries. Our previous case-series study showed that the use of self-cut mesh had a good success rate (91.8% at 1-year follow-up) and low complication rate. This trial is designed to compare a self-cut titanium-coated polypropylene mesh procedure with a mesh kit for the treatment of symptomatic stage III–IV anterior or apical prolapse in terms of efficacy, safety and cost-effectiveness.

Methods

The trial is a randomized controlled multicenter non-inferiority trial. The primary outcome measure is the composite success rate at 1-year follow-up. The secondary outcomes are anatomic outcomes of each vaginal segment (anterior, posterior and apical) using the POP-Q score, subjective improvement of quality of life according to questionnaires, intraoperative parameters, complications and costs. Analysis will be performed according to the intention-to-treat principle. Based on a comparable success rate of 90% and 10% as the margin (β = 0.2 and one-sided α = 0.025), about 312 patients in total from 11 centers will be recruited including 10% dropout. The aims of the research are to demonstrate whether the self-cut mesh procedure is non-inferior to the mesh-kit procedure and to investigate the performance of titanium-coated mesh for vaginal prolapse repair.

Discussion

This multicenter non-inferiority trial will evaluate whether the efficacy and safety of self-cut mesh is non-inferior to mesh kits in women with severe symptomatic stage III–IV anterior or apical prolapse. If we are able to show that the self-cut mesh procedure is non-inferior to the mesh-kit procedure in success rates, then the self-cut mesh procedure may be more cost-effective.

Trial registration

ClinicalTrials.gov, NCT03283124. Registered on 17 January 2018.
Appendix
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Literature
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Metadata
Title
Self-cut titanium-coated polypropylene mesh versus pre-cut mesh-kit for transvaginal treatment of severe pelvic organ prolapse: study protocol for a multicenter non-inferiority trial
Authors
Juan Chen
Jiajie Yu
Abraham Morse
Christian Fünfgeld
Kuanhui Huang
Jian Gong
Guangshi Tao
Binan Wang
Yuling Wang
Xiangyang Jiang
Gulina Ababaikeli
Peishu Liu
Hatiguli Nisier
Xiaowei Zhang
Ping Wang
Xin Sun
Lan Zhu
Publication date
01-12-2020
Publisher
BioMed Central
Published in
Trials / Issue 1/2020
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-019-3966-3

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