NCT04878146: ProSac

Sacrocolpopexy Versus Sacro-spinous Fixation for Prolapse Treatment

Not yet recruiting NA Last updated 7 May 2021

What this trial tests

NA trial testing Sacro-spinous fixation in Pelvic Organ Prolapse in 132 participants. Not yet recruiting.

Timeline

1 July 2021

Primary endpoint
30 June 2026

30 June 2028

Quick facts

Lead sponsor	Centre Hospitalier Universitaire Vaudois
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	132
Start date	1 July 2021
Primary completion	30 June 2026
Estimated completion	30 June 2028

Drugs / interventions tested

• Sacro-spinous fixation
• Subtotal hysterectomy
• Sacrocolpopexy

Conditions studied

• Pelvic Organ Prolapse — all drugs for Pelvic Organ Prolapse →

Sponsor

Centre Hospitalier Universitaire Vaudois

Who can join

30 and older, female only, with Pelvic Organ Prolapse. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.