Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
834 participants
INTERVENTIONAL
2019-09-11
2025-12-31
Brief Summary
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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 Furthermore the posterior mesh increases the procedure by a minimum of 30 minutes (Robolaps study, unpublished data).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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Single-Anterior-Mesh, SAM
Single-Anterior-Mesh, SAM
laparoscopic sacropexy is only performed with the anterior mes
Double-Mesh, DM
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
Interventions
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Single-Anterior-Mesh, SAM
laparoscopic sacropexy is only performed with the anterior mes
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
75 Years
FEMALE
No
Sponsors
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Ministry of Health, France
OTHER_GOV
University Hospital, Lille
OTHER
Responsible Party
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Principal Investigators
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Jean-Philippe LUCOT, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Lille
Locations
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Hopital Estaing
Clermont-Ferrand, , France
Ch Dunkerque
Dunkirk, , 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
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Role: primary
Other Identifiers
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2018-A01487-48
Identifier Type: OTHER
Identifier Source: secondary_id
PHRCN-17-0226
Identifier Type: OTHER
Identifier Source: secondary_id
2017_74
Identifier Type: -
Identifier Source: org_study_id
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