LAparoscopic Preventive PRErectal Mesh

  • STATUS
    Recruiting
  • End date
    Jul 26, 2023
  • participants needed
    834
  • sponsor
    University Hospital, Lille
Updated on 26 January 2021
brimonidine tartrate ophthalmic solution
incontinence
sacrocolpopexy
vaginal prolapse
posterior vaginal wall prolapse

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 Furthermore the posterior mesh increases the procedure by a minimum of 30 minutes (Robolaps study, unpublished data).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

Details
Condition Ptosis, Vaginal Vault Prolapse, Genitourinary Prolapse, pelvic organ prolapse
Treatment Single-Anterior-Mesh, SAM, Double-Mesh, DM
Clinical Study IdentifierNCT03766048
SponsorUniversity Hospital, Lille
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

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
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