LAparoscopic Preventive PRErectal Mesh

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

Overview

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 Furthermore the posterior mesh increases the procedure by a minimum of 30 minutes (Robolaps study, unpublished data).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

Interventions

• Procedure Single-Anterior-Mesh, SAM
  laparoscopic sacropexy is only performed with the anterior mes
• Procedure 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

Primary outcome measures

• Composite criteria of success at 2 years follow-up [Time frame: at 2 years after the intervention]

Secondary outcome measures (1)

• Anatomical results [Time frame: at 2 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

France · 9 centers

• Hopital Estaing — Clermont-Ferrand
• Ch Dunkerque — Dunkirk
• Hopital Saint-Louis - La Rochelle — La Rochelle
• Clinique Du Pre — Le Mans
• Hop Jeanne de Flandre Chu Lille — Lille
• Hopital Saint Vincent - Saint Antoine — Lille
• Chu de Nice Hopital de L'Archet — Nice
• Chu Nimes - Nimes — Nîmes
• … and 1 more center

Identifiers

NCT: NCT03766048 · 2017_74 · 2018-A01487-48 · PHRCN-17-0226

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗