ArticleTrials2020
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.
Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03283124 (A Multicenter Randomized Controlled Non-inferiority Trial Comparing Transvaginal Self-tailored Titanium-coated Polypropylene Mesh Procedure With Mesh-kit Procedure.), which is not on this map. Cited by 2 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Multicenter Randomized Controlled Non-inferiority Trial Comparing Transvaginal Self-tailored Titanium-coated Polypropylene Mesh Procedure With Mesh-kit Procedure.
Who cites it
2 citing papers in PubMed.
- Effectiveness of Self-cut vs Mesh-Kit Titanium-Coated Polypropylene Mesh for Transvaginal Treatment of Severe Pelvic Organ Prolapse: A Multicenter Randomized Noninferiority Clinical Trial.JAMA network open · 2022Trial
- Predicting the occurrence of stress urinary incontinence after prolapse surgery: a machine learning-based model.Annals of translational medicine · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
17 authors.
Funding
Abstract
backgroundPelvic 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.
methodsThe 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 registrationClinicalTrials.gov, NCT03283124. Registered on 17 January 2018.
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