LAPREM: LAparoscopic Preventive PRErectal Mesh

Sponsor

University Hospital, Lille (Other)

Overall Status

Recruiting

CT.gov ID

NCT03766048

Collaborator

Ministry of Health, France (Other)

834

Enrollment

Locations

Arms

45.6

Anticipated Duration (Months)

92.7

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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 Furthermore the posterior mesh increases the procedure by a minimum of 30 minutes (Robolaps study, unpublished data).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

Condition or Disease	Intervention/Treatment	Phase
Urogenital Prolapse	Procedure: Single-Anterior-Mesh, SAM Procedure: Double-Mesh, DM	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

834 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Non-inferiority Randomized Double Blind Controlled Trial Comparing Results of Laparoscopic Sacrocolpopexy With or Without Preventive Prerectal Mesh in Women Operated for Urogenital Prolapse Without Significant Posterior Vaginal Wall Prolapse

Actual Study Start Date :

Sep 11, 2019

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Single-Anterior-Mesh, SAM	Procedure: Single-Anterior-Mesh, SAM laparoscopic sacropexy is only performed with the anterior mes
Sham Comparator: Double-Mesh, DM	Procedure: Double-Mesh, DM laparoscopic sacropexy is performed using two synthetic non-absorbable meshes, both sutured to the promontory (Double-Mesh, DM): one mesh is placed in the vesicovaginal space and sutured to the uterine cervix or vaginal apex, and one mesh is placed in the rectovaginal space

Arm

Intervention/Treatment

Experimental: Single-Anterior-Mesh, SAM

Procedure: Single-Anterior-Mesh, SAM

laparoscopic sacropexy is only performed with the anterior mes

Sham Comparator: Double-Mesh, DM

Procedure: Double-Mesh, DM

laparoscopic sacropexy is performed using two synthetic non-absorbable meshes, both sutured to the promontory (Double-Mesh, DM): one mesh is placed in the vesicovaginal space and sutured to the uterine cervix or vaginal apex, and one mesh is placed in the rectovaginal space

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 75 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Hopital Estaing	Clermont-Ferrand	France
2	Ch Dunkerque	Dunkerque	France
3	Hopital Saint-Louis - La Rochelle	La Rochelle	France
4	Clinique Du Pre	Le Mans	France
5	Hop Jeanne de Flandre Chu Lille	Lille	France	59037
6	Hopital Saint Vincent - Saint Antoine	Lille	France	59037
7	Chu de Nice Hopital de L'Archet	Nice	France
8	Chu Nimes - Nimes	Nîmes	France
9	Chi Poissy St Germain Site de Poissy	Poissy	France