LAparoscopic Preventive PRErectal Mesh

Urogenital Prolapse Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03766048
• Other study ID #: 2017_74
• Secondary ID: 2018-A01487-48PH
• Status: Recruiting
• Phase: N/A
• Start date: September 11, 2019
• Est. completion date: December 2025

Study information

• Verified date: February 2023
• Source: University Hospital, Lille
• Contact: Jean-Philippe LUCOT, MD,PhD
• Phone: (0)3 21 45 62
• Email: lucot.jean-philippe[@]ghicl.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 834
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse
• Urogenital Prolapse

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
France	Hopital Estaing	Clermont-Ferrand
France	Ch Dunkerque	Dunkerque
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

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Lille	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	at 2 years