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 (LAPREM)
Interventional
N/A
University Hospital, Lille (Voir sur ClinicalTrials)
septembre 2019
décembre 2025
29 juin 2024
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unpublished data).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