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NOT YET RECRUITING
NCT04878146
NA

Sacrocolpopexy Versus Sacro-spinous Fixation for Prolapse Treatment

Sponsor: Centre Hospitalier Universitaire Vaudois

View on ClinicalTrials.gov

Summary

Prolapse is a condition that causes up to 13% of women to have surgery in their lifetime. There are many surgical techniques for the treatment of prolapse, each with its advantages and disadvantages. The techniques by vaginal approach aim to put back in tension the supporting tissue, the endopelvic fascia, damaged and released. This technique has the advantage of not causing an abdominal scar, a quick recovery and often little pain. In contrast, the use of already damaged native tissue results in a recurrence rate of up to 15% to 30%. The other technique is the abdominal route either by laparotomy or by a minimally invasive approach such as laparoscopy, assisted or not by robotics. With this technique, we use prosthetic material introduced around the vaginal wall without opening the latter, therefore without contamination and without dissection of the vaginal wall. During upper surgery, a subtotal hysterectomy is performed, that is to say that the uterine cervix is preserved and serves as an anchoring point for the synthetic nets which are attached to the cervix and then sutured to the promontory of the sacrum. (sacrocervicopexy). In the vaginal route, a total hysterectomy is traditionally performed and the vaginal dome is sutured to the sacro-spinal ligament (Richter's operation). The stitches are then passed through the thickness of the often thin vaginal wall constituting a possible release point of the assembly. There are currently no studies that compare prosthetic sacrocervicopexy with fixation of the remaining cervix to the sacro-spinal ligament without prosthesis, and repair of the endopelvic fascia with native tissue. The study consists of performing a subtotal hysterectomy by minimally invasive approach in both cases and then randomize for either a prosthetic sacrocervicopexy or fixation of the remaining cervix to the sacro-spinal ligament via the abdominal or vaginal route.

Official title: Comparaison Entre la Sacrocervicopexie (SCP) et la Fixation Sacro-spinale (FSS) du Col utérin Dans le Traitement du Prolapsus génital: Etude Prospective randomisée: Etude "ProSac "

Key Details

Gender

FEMALE

Age Range

30 Years - Any

Study Type

INTERVENTIONAL

Enrollment

132

Start Date

2021-07-01

Completion Date

2028-06-30

Last Updated

2021-05-07

Healthy Volunteers

No

Interventions

PROCEDURE

Sacro-spinous fixation

Uterine cervix will be attached to the sacro-spinous ligament

PROCEDURE

Subtotal hysterectomy

Done on both arms

PROCEDURE

Sacrocolpopexy

Uterine cervix is attached to sacral promontory with two synthetic meshes