Informations générales (source: ClinicalTrials.gov)
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
Interventional
N/A
University Hospital, Lille (Voir sur ClinicalTrials)
septembre 2019
décembre 2025
18 septembre 2025
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unpublished data).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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHI POISSY ST-GERMAIN | Contact (sur clinicalTrials) | ||||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Ch Dunkerque - Dunkerque - France | Contact (sur clinicalTrials) | ||||
| Chu de Nice Hopital de L'Archet - Nice - France | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Chu Nimes - Nimes - Nîmes - France | Contact (sur clinicalTrials) | ||||
| Clinique Du Pre - Le Mans - France | Contact (sur clinicalTrials) | ||||
| Hop Jeanne de Flandre Chu Lille - 59037 - Lille - France | Contact (sur clinicalTrials) | ||||
| Hopital Estaing - Clermont-Ferrand - France | Contact (sur clinicalTrials) | ||||
| Hopital Saint Vincent - Saint Antoine - 59037 - Lille - France | Contact (sur clinicalTrials) | ||||
| Hopital Saint-Louis - La Rochelle - La Rochelle - France | Contact (sur clinicalTrials) | ||||
Critères
Femme
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),
- 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),
- 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