search
Back to results

LAparoscopic Preventive PRErectal Mesh (LAPREM)

Primary Purpose

Urogenital Prolapse

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Single-Anterior-Mesh, SAM
Double-Mesh, DM
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urogenital Prolapse focused on measuring Urogenital prolapse, laparoscopic sacropexy, mesh, medico-economic study

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Hopital EstaingRecruiting
  • Ch DunkerqueRecruiting
  • Hopital Saint-Louis - La RochelleRecruiting
  • Clinique Du PreRecruiting
  • Hop Jeanne de Flandre Chu LilleRecruiting
  • Hopital Saint Vincent - Saint AntoineRecruiting
  • Chu de Nice Hopital de L'ArchetRecruiting
  • Chu Nimes - NimesRecruiting
  • Chi Poissy St Germain Site de PoissyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Single-Anterior-Mesh, SAM

Double-Mesh, DM

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Anatomical results
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

Full Information

First Posted
December 3, 2018
Last Updated
February 3, 2023
Sponsor
University Hospital, Lille
Collaborators
Ministry of Health, France
search

1. Study Identification

Unique Protocol Identification Number
NCT03766048
Brief Title
LAparoscopic Preventive PRErectal Mesh
Acronym
LAPREM
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 11, 2019 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
Collaborators
Ministry of Health, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urogenital Prolapse
Keywords
Urogenital prolapse, laparoscopic sacropexy, mesh, medico-economic study

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
834 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single-Anterior-Mesh, SAM
Arm Type
Experimental
Arm Title
Double-Mesh, DM
Arm Type
Sham Comparator
Intervention Type
Procedure
Intervention Name(s)
Single-Anterior-Mesh, SAM
Intervention Description
laparoscopic sacropexy is only performed with the anterior mes
Intervention Type
Procedure
Intervention Name(s)
Double-Mesh, DM
Intervention Description
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
Primary Outcome Measure Information:
Title
Composite criteria of success at 2 years follow-up
Description
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.
Time Frame
at 2 years after the intervention
Secondary Outcome Measure Information:
Title
Anatomical results
Description
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
Time Frame
at 2 years

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Women with a urogenital prolapse for whom a laparoscopic sacrocolpopexy is planned.
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Philippe LUCOT, MD,PhD
Phone
(0)3 21 45 62
Ext
+33
Email
lucot.jean-philippe@ghicl.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Philippe LUCOT, MD,PhD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Estaing
City
Clermont-Ferrand
Country
France
Individual Site Status
Recruiting
Facility Name
Ch Dunkerque
City
Dunkerque
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Saint-Louis - La Rochelle
City
La Rochelle
Country
France
Individual Site Status
Recruiting
Facility Name
Clinique Du Pre
City
Le Mans
Country
France
Individual Site Status
Recruiting
Facility Name
Hop Jeanne de Flandre Chu Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Contact:
Phone
0320445962
Facility Name
Hopital Saint Vincent - Saint Antoine
City
Lille
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Contact:
Phone
0320445962
Facility Name
Chu de Nice Hopital de L'Archet
City
Nice
Country
France
Individual Site Status
Recruiting
Facility Name
Chu Nimes - Nimes
City
Nîmes
Country
France
Individual Site Status
Recruiting
Facility Name
Chi Poissy St Germain Site de Poissy
City
Poissy
Country
France
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

LAparoscopic Preventive PRErectal Mesh

We'll reach out to this number within 24 hrs