LAparoscopic Preventive PRErectal Mesh

Last updated: February 3, 2023
Sponsor: University Hospital, Lille
Overall Status: Active - Recruiting

Phase

N/A

Condition

Genitourinary Prolapse

Treatment

N/A

Clinical Study ID

NCT03766048
2017_74
PHRCN-17-0226
2018-A01487-48
  • Ages 40-75
  • Female

Study Summary

Urogenital prolapse is a frequent and invalidating pathology in women, involving the anterior vaginal wall and the uterus in most cases. Posterior vaginal wall prolapse is present in only 50% of cases. Surgery is an option for women with troublesome prolapse. A woman's lifetime risk of undergoing surgery for pelvic organ prolapse (POP) surgery by the age of 80 is around 19%. Laparoscopic sacrocolpopexy (LS) with synthetic non-absorbable mesh is considered the gold standard, with a composite success rate of 85% at one year (Prospere study). Based on early experience and historical habits, a prerectal mesh was used to be systematically placed in the rectovaginal space, in addition to the anterior and apical mesh placed in the vesicovaginal space, in order to prevent de-novo posterior prolapse (reported rates up to 33%).

The benefit of preventive prerectal mesh is questionned on the basis of a single retrospective study comparing 68 LS with double-mesh (anterior & posterior, DM) to 32 LS with a single anterior mesh (SAM): posterior recurrence rates were respectively 5.9 vs. 31.3% (p<0,01), and total recurrence rates 16.2 vs. 43.8% (p<0.01). However, as this difference was not significant in the subgroup of patients without associated cervicocystopexy, the authors concluded that the risk of posterior failure was only due to the cervicocystopexy itself (anti-urinary incontinence procedure which has been abandoned since).

On the other hand, a prerectal mesh increases the risk for specific complications: rectal injury (up to 3%), anal pain (up to 25%), mesh exposition (up to 2%). Furthermore the posterior mesh increases the procedure by a minimum of 30 minutes (Robolaps study, unpublished data). The rate of de-novo obstructed defecation after LS with prerectal mesh is reported up to 25%. It could be explained by the mesh itself, but also by nerve injuries during the dissection of the rectovaginal space and rectal stalks.

Eligibility Criteria

Inclusion

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 prolapseis reduced using a retractor leaving the posterior vaginal wall free),

Exclusion

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

Study Design

Total Participants: 834
Study Start date:
September 11, 2019
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Hopital Estaing

    Clermont-Ferrand,
    France

    Active - Recruiting

  • Ch Dunkerque

    Dunkerque,
    France

    Active - Recruiting

  • Hopital Saint-Louis - La Rochelle

    La Rochelle,
    France

    Active - Recruiting

  • Clinique Du Pre

    Le Mans,
    France

    Active - Recruiting

  • Hop Jeanne de Flandre Chu Lille

    Lille, 59037
    France

    Active - Recruiting

  • Hopital Saint Vincent - Saint Antoine

    Lille, 59037
    France

    Active - Recruiting

  • Chu de Nice Hopital de L'Archet

    Nice,
    France

    Active - Recruiting

  • Chu Nimes - Nimes

    Nîmes,
    France

    Active - Recruiting

  • Chi Poissy St Germain Site de Poissy

    Poissy,
    France

    Active - Recruiting

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