LAparoscopic Preventive PRErectal Mesh

Launched by UNIVERSITY HOSPITAL, LILLE · Dec 3, 2018

Keywords

ClinConnect Summary

**Trial Summary: Laparoscopic Preventive Prerectal Mesh for Urogenital Prolapse**

This clinical trial is studying a surgical procedure called laparoscopic sacrocolpopexy (LS) to help women with urogenital prolapse, a condition where pelvic organs, like the bladder or uterus, drop from their normal positions. The trial is specifically looking at whether adding a mesh in a certain area (the rectovaginal space) can help prevent future problems with the back wall of the vagina. While the standard surgery has a high success rate, researchers want to see if using this extra mesh can reduce the chance of later issues but also want to weigh this against the risks of complications that may arise from the additional mesh.

To participate in this trial, women must have a specific type of urogenital prolapse but should not have significant issues with the back wall of the vagina. Key criteria for joining include being between the ages of 14 and 27 and being able to read and understand French to provide consent. Participants will undergo the surgery and will be monitored for any complications or improvements in their condition. It's important to note that while this trial aims to explore the benefits of the additional mesh, it also acknowledges potential risks, such as pain or injury. If you or someone you know is affected by urogenital prolapse and meets the criteria, this could be an opportunity to contribute to important research.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Women with a urogenital prolapse (anterior wall and/or uterus or vaginal apex) stage = 2 (Ba and/or C points ≥ - 1 cm using the POP-Q system),
• • without significant posterior vaginal wall prolapse (Bp \< -1 cm when apical prolapse is reduced using a retractor leaving the posterior vaginal wall free),
• Exclusion Criteria:
• • Previous surgical repair for Pelvic Organ Prolapse
• • Any associated prolapse requiring any non-authorized additional surgical repair (Authorized additional surgical procedures are hysterectomy, ovariectomy, adnexectomy, salpingectomy, myomectomy, or suburethral vaginal tape.)
• • Wish for future pregnancy
• • Lack of health insurance
• • Woman not reading French or unable to consent
• • Woman under law protection