[PROSPERE randomized controlled trial: laparoscopic sacropexy versus vaginal mesh for cystocele POP repair]. / Étude randomisée comparant la promontofixation cÅlioscopique à la chirurgie prothétique par voie vaginale pour le traitement des cystocèles : PROSPERE (PROSthetic PElvic organ prolapse REpair).
J Gynecol Obstet Biol Reprod (Paris)
; 42(4): 334-41, 2013 Jun.
Article
in Fr
| MEDLINE
| ID: mdl-23618743
ABSTRACT
BACKGROUND:
Cystocele is a frequent and invalidating type of genital prolapse in woman. Sacropexy using synthetic mesh is considered the surgical gold standard, and the laparoscopic approach has supplanted the open abdominal route because it offers the same anatomical results with a lower morbidity. The use of mesh through the vaginal route may have many advantages easiness to perform, shorter operative time and recovery, but may increase morbidity. In France, both laparoscopic sacropexy and vaginal mesh are commonly used to treat cystoceles. The French Haute Autorité de santé (HAS) has highlighted the lack of evaluation of safety assessment for vaginal meshes. METHOD/DESIGN:
The main objective of the study is to compare the morbidity of laparoscopic sacropexy with vaginal mesh for cystocele repair. The primary endpoint will be the rate of surgical complications greater or equal to grade 2 of the Clavien-Dindo classification at 1-year follow-up. The secondary aims are to compare the functional results in the medium term (sexuality, urinary and bowel symptoms, pain), the impact on quality of life as well as anatomical results. PROSPERE is a randomized controlled trial conducted in 12 participating French hospitals. 262 patients, aged 45 to 75years old, with cystocele greater or equal to stage 2 of the POP-Q classification (isolated or not) will be included. Exclusion criterias are a previous surgical POP repair, and inability or contra-indication to one or the other technique. We have designed this study to answer the question of the choice between laparoscopic sacropexy and vaginal mesh for the treatment of cystocele. The PROSPERE trial aims to help better determine the indications for one or the other of these techniques, which are currently based on subjective choices or school attitudes. This is the reason why competent authorities have asked for such studies.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Gynecologic Surgical Procedures
/
Surgical Mesh
/
Uterine Prolapse
/
Laparoscopy
/
Cystocele
Type of study:
Clinical_trials
/
Etiology_studies
Aspects:
Patient_preference
Limits:
Aged
/
Female
/
Humans
/
Middle aged
Language:
Fr
Journal:
J Gynecol Obstet Biol Reprod (Paris)
Year:
2013
Document type:
Article
Affiliation country:
France