LAparoscopic Preventive PRErectal Mesh
Recruiting now · Not applicable
Conditions studied: Urogenital Prolapse
In brief
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 Furthermore the posterior mesh increases the procedure by a minimum of 30 minutes (Robolaps study, unpublished data).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.
Key facts
- Study ID
- NCT03766048
- Run by
- University Hospital, Lille
- People needed
- 834
- Starts
- 2019-09-11
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2026-05-22
Who can join
Age: 40 and older, up to 75. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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),
You may not qualify if…
- 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
Where it is running
- Hopital Estaing — Clermont-Ferrand, France (enrolling)
- Ch Dunkerque — Dunkirk, France (enrolling)
- Hopital Saint-Louis - La Rochelle — La Rochelle, France (enrolling)
- Clinique Du Pre — Le Mans, France (enrolling)
- Hop Jeanne de Flandre Chu Lille — Lille, France (enrolling)
- Hopital Saint Vincent - Saint Antoine — Lille, France (enrolling)
- Chu de Nice Hopital de L'Archet — Nice, France (enrolling)
- Chu Nimes - Nimes — Nîmes, France (enrolling)
- Chi Poissy St Germain Site de Poissy — Poissy, France (enrolling)
Full record on ClinicalTrials.gov
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