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Sacrocolpopexy Versus Sacro-spinous Fixation for Prolapse Treatment

NCT04878146 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2021-05-07

No results posted yet for this study

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.

Conditions

  • Pelvic Organ Prolapse

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

Sponsors & Collaborators

  • Centre Hospitalier Universitaire Vaudois

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-01
Primary Completion
2026-06-30
Completion
2028-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04878146 on ClinicalTrials.gov