NCT01637441

Prosthetic Pelvic Organ Prolapse Repair

Randomized Study Comparing Laparoscopic Sacropexy and Vaginal Mesh Surgery in Cystocele Repair

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 262 (actual)
• Sponsor: University Hospital, Lille · Academic / Other
• Sex: Female
• Age: 45 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The cystocele is the most frequent clinical shape of the genital prolapse. It is a frequent pathology in woman which can impair quality of life and generates pelvic, urinary or sexual functional disorders. It's considered that 8 % of women will be undergo surgery in this indication before the age of 80 years. Numerous surgical techniques have been described and we distinguish the interventions according to the route (vaginal or abdominal), and according to the use or not of synthetic mesh (non-absorbable) to increase the anatomical results.

Detailed description

This is a multicenter, randomized, comparative, 2-parallel-arm study in patients with pelvic organ prolapse (cystocele) Approximately 260 patients aged from 45 to 75 years will be allocated to have laparoscopic sacropexy or vaginal mesh surgery.

Conditions

• Cystocele

Interventions

Type	Name	Description
PROCEDURE	laparoscopic sacropexy	under laparoscopic vision, the vesico-vaginal space is dissected until the level of the bladder neck. a synthetic non absorbable mesh is placed between the bladder and the vagina. the mesh is sutured to the vagina and the apex (vaginal apex or uterus) and anchored to the prevertebral ligament in front of the promontorium.
PROCEDURE	vaginal mesh	after anterior sagittal colpotomy, the bladder is dissected under the fascia layer, and the paravesical fossa are entered. a synthetic non absorbable mesh is placed with 4 arms suspension (trans obturator or not). treatment of the apex is mandatory.

Timeline

• Start date: 2012-09-01
• Primary completion: 2015-07-01
• Completion: 2015-11-01
• First posted: 2012-07-11
• Last updated: 2015-11-04

Locations

12 sites across 1 country: France