LAparoscopic Preventive PRErectal Mesh (LAPREM)
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
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 Furthermore the posterior mesh increases the procedure by a minimum of 30 minutes (Robolaps study, unpublished data).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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jean-Philippe LUCOT, MD,PhD
- Phone Number: +33 (0)3 21 45 62
- Email: lucot.jean-philippe@ghicl.net
Study Locations
-
-
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Clermont-Ferrand, France
- Recruiting
- Hopital Estaing
-
Dunkirk, France
- Recruiting
- CH Dunkerque
-
La Rochelle, France
- Recruiting
- Hôpital Saint-Louis - La Rochelle
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Le Mans, France
- Recruiting
- Clinique du Pré
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Lille, France, 59037
- Recruiting
- Hop Jeanne de Flandre Chu Lille
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Contact:
- Phone Number: 0320445962
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Lille, France, 59037
- Recruiting
- Hopital Saint Vincent - Saint Antoine
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Contact:
- Phone Number: 0320445962
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Nice, France
- Recruiting
- CHU De Nice Hopital De l'Archet
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Nîmes, France
- Recruiting
- Chu Nimes - Nimes
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Poissy, France
- Recruiting
- Chi Poissy St Germain Site de Poissy
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Single-Anterior-Mesh, SAM
|
laparoscopic sacropexy is only performed with the anterior mes
|
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Sham Comparator: 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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Composite criteria of success at 2 years follow-up
Time Frame: 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.
|
at 2 years after the intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anatomical results
Time Frame: 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
|
at 2 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jean-Philippe LUCOT, MD,PhD, University Hospital, Lille
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathological Conditions, Anatomical
- Prolapse
- Pathological Conditions, Signs and Symptoms
- Pelvic Organ Prolapse
- Amino Acids, Peptides, and Proteins
- Sulfur Compounds
- Organic Chemicals
- Heterocyclic Compounds
- Heterocyclic Compounds, 2-Ring
- Heterocyclic Compounds, Fused-Ring
- Nucleic Acids, Nucleotides, and Nucleosides
- Purines
- Amino Acids
- Nucleosides
- Ribonucleosides
- Amino Acids, Sulfur
- Adenosine
- Purine Nucleosides
- Methionine
- S-Adenosylmethionine
Other Study ID Numbers
- 2017_74
- 2018-A01487-48 (Other Identifier: ID-RCB number, ANSM)
- PHRCN-17-0226 (Other Identifier: PHRC number, DGOS)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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