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NCT Number: NCT03766048

LAparoscopic Preventive PRErectal Mesh

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 Furthermore the posterior mesh increases the procedure by a minimum of 30 minutes (Robolaps study, unpublished data).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.

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Key information

Age range

40 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Estaing, Clermont-Ferrand, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Single-Anterior-Mesh, SAM

Procedure

laparoscopic sacropexy is only performed with the anterior mes

Double-Mesh, DM

Procedure

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 outcomes

  1. 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.

Secondary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Jean-Philippe LUCOT, MD,PhD

CONTACT

[email protected]

(0)3 21 45 62 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study 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

Acronym: LAPREM

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Dec 5, 2018
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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