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Comparing Transvaginal Self-tailored Titanium-coated Polypropylene Mesh Procedure With Mesh-kit Procedure.

2017-09-15 00:23:21 | BioPortfolio

Summary

Pelvic organ prolapse(POP) is a common health problem and has significant negative effects on woman's quality of life. Transvaginal mesh procedure is a durable reconstructive surgery, but the mesh kits are expensive for underdeveloped countries. Our preliminary trial showed that the use of self-tailored mesh had good success rate (91.8% at 1-year follow-up) and low complication rate. The trial is designed to compare self-tailored titanium-coated polypropylene mesh procedure with mesh-kit in the treatment of POP stage III-IV in terms of efficacy, safety and cost-effective .

Description

The trial is a randomized controlled multi-center non-inferiority trial. The primary outcome measure is success rate at 1-year follow-up. The second outcomes are subjective improvement of quality of life, complications and costs. Analysis will be performed according to the intention to treat principle. Based on comparable success rate of 92% and 10% as the margin(beta 0.2 and one sided alpha 0.025), about 524 patients in total from 15 centers will be recruited per group including 10% drop-out. The aims of the research are to demonstrate whether self-tailored mesh is non-inferior to the mesh-kit. The finding of this research might influence the treatment selection for POP in China.

Study Design

Conditions

Pelvic Organ Prolapse

Intervention

pelvic floor reconstructive surgery

Location

The First Affiliated Hospital of Guangzhou Medical College
Guangzhou
Guangdong
China

Status

Recruiting

Source

Peking Union Medical College Hospital

Results (where available)

View Results

Links

Published on BioPortfolio: 2017-09-15T00:23:21-0400

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Medical and Biotech [MESH] Definitions

Injury, weakening, or PROLAPSE of the pelvic muscles, surrounding connective tissues or ligaments (PELVIC FLOOR).

Soft tissue formed mainly by the pelvic diaphragm, which is composed of the two levator ani and two coccygeus muscles. The pelvic diaphragm lies just below the pelvic aperture (outlet) and separates the pelvic cavity from the PERINEUM. It extends between the PUBIC BONE anteriorly and the COCCYX posteriorly.

Abnormal descent of a pelvic organ resulting in the protrusion of the organ beyond its normal anatomical confines. Symptoms often include vaginal discomfort, DYSPAREUNIA; URINARY STRESS INCONTINENCE; and FECAL INCONTINENCE.

Endoscopic examination, therapy or surgery of the female pelvic viscera by means of an endoscope introduced into the pelvic cavity through the posterior vaginal fornix.

The part of the pelvis, inferior to the pelvic brim, that comprises both the pelvic cavity and the part of the PERINEUM lying inferior to the PELVIC DIAPHRAGM.

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