Clinical trial NCT03766048: LAparoscopic Preventive PRErectal Mesh
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Urogenital Prolapse
Keywords: Urogenital prolapse
laparoscopic sacropexy
mesh
medico-economic study
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2018-12-05
Enrollment: 834
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Composite criteria of success at 2 years follow-up
timeFrame: at 2 years after the intervention
Secondary outcomes:
measure: Anatomical results
timeFrame: at 2 years
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Hopital Estaing
city: Dunkerque
country: France
facility: Ch Dunkerque
city: La Rochelle
country: France
facility: Hopital Saint-Louis - La Rochelle
city: Le Mans
country: France
facility: Clinique Du Pre
city: Lille
country: France
facility: Hop Jeanne de Flandre Chu Lille
city: Lille
country: France
facility: Hopital Saint Vincent - Saint Antoine
city: Nice
country: France
facility: Chu de Nice Hopital de L'Archet
city: Nîmes
country: France
facility: Chu Nimes - Nimes
city: Poissy
country: France
facility: Chi Poissy St Germain Site de Poissy
Study officials:
affiliation: University Hospital, Lille
name: Jean-Philippe LUCOT, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: