LAparoscopic Preventive PRErectal Mesh

Not Applicable

Recruiting

• Conditions: Urogenital Prolapse

• Registration Number: NCT03766048
• Lead Sponsor: University Hospital, Lille

Brief 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 Furthermore the posterior mesh increases the procedure by a minimum of 30 minutes (Robolaps study, unpublished data).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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-12-03
• Study First Submitted QC: 2018-12-03
• Study First Posted: 2018-12-05
• Study Start: 2019-09-11
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-03
• Last Update Posted: 2023-02-06
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 834

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Composite criteria of success at 2 years follow-up	at 2 years after the intervention	Composite criteria of success at 2 years follow-up: no symptom of vaginal bulge, no prolapse beyond the hymen (\>0 cm), no reintervention for prolapse recurrence. Its advantage is that it considers only recurrences that are symptomatic or needing a reintervention. It is strongly linked with women satisfaction after prolapse surgery.

Secondary Outcome Measures

Name	Time	Method
Anatomical results	at 2 years	Anatomical results will be based on clinical evaluation of patients at 2 years follow-up using the POP-Q system, with a specific evaluation of posterior vaginal wall with measures of the Bp point

Trial Locations

Locations (9)

Hopital Estaing; 🇫🇷 Clermont-Ferrand, France

Ch Dunkerque; 🇫🇷 Dunkerque, France

Hopital Saint-Louis - La Rochelle; 🇫🇷 La Rochelle, France

Clinique Du Pre; 🇫🇷 Le Mans, France

Hop Jeanne de Flandre Chu Lille; 🇫🇷 Lille, France

Hopital Saint Vincent - Saint Antoine; 🇫🇷 Lille, France

Chu de Nice Hopital de L'Archet; 🇫🇷 Nice, France

Chu Nimes - Nimes; 🇫🇷 Nîmes, France

Chi Poissy St Germain Site de Poissy; 🇫🇷 Poissy, France