LAparoscopic Preventive PRErectal Mesh

NCT03766048 | Unknown DMC

• 3 other identifiers: 2017_742018-A01487-48PHRCN-17-0226
• Study Type: interventional
• Target: 834
• Locations: 1 country
• Sites: 9

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 Furthermore the posterior mesh increases the procedure by a minimum of 30 minutes (Robolaps study, unpublished data).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

Conditions

Urogenital Prolapse

Keywords

Urogenital prolapse; laparoscopic sacropexy; mesh; medico-economic study

Outcome Measures

Primary Outcomes (1)

• Composite criteria of success at 2 years follow-up

  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.

  at 2 years after the intervention

Secondary Outcomes (1)

• Anatomical results

  at 2 years

Study Arms (2)

Single-Anterior-Mesh, SAM

EXPERIMENTAL

Procedure: Single-Anterior-Mesh, SAM

Double-Mesh, DM

SHAM COMPARATOR

Procedure: Double-Mesh, DM

Interventions

Single-Anterior-Mesh, SAM PROCEDURE

laparoscopic sacropexy is only performed with the anterior mes

Single-Anterior-Mesh, SAM

Double-Mesh, DM PROCEDURE

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

Double-Mesh, DM

Eligibility Criteria

• Age: 40 Years - 75 Years
• Gender Eligibility Details: Women with a urogenital prolapse for whom a laparoscopic sacrocolpopexy is planned.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University Hospital, Lille: lead
• Ministry of Health, France: collaborator

Study Sites (9)

Hopital Estaing

Clermont-Ferrand, France

RECRUITING

Ch Dunkerque

Dunkirk, France

RECRUITING

Hopital Saint-Louis - La Rochelle

La Rochelle, France

RECRUITING

Clinique Du Pre

Le Mans, France

RECRUITING

Hop Jeanne de Flandre Chu Lille

Lille, 59037, France

RECRUITING

Hopital Saint Vincent - Saint Antoine

Lille, 59037, France

RECRUITING

Chu de Nice Hopital de L'Archet

Nice, France

RECRUITING

Chu Nimes - Nimes

Nîmes, France

RECRUITING

Chi Poissy St Germain Site de Poissy

Poissy, France

RECRUITING

MeSH Terms

Conditions

Pelvic Organ Prolapse

Interventions

S-Adenosylmethionine

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Methionine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Amino Acids; Amino Acids, Peptides, and Proteins; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Jean-Philippe LUCOT, MD,PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-Philippe LUCOT, MD,PhD

CONTACT

(0)3 21 45 62; lucot.jean-philippe@ghicl.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2018
• First Posted: December 5, 2018
• Study Start: September 11, 2019
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 6, 2023

Record last verified: 2023-02

Locations

FR (9)