Sacrocolpopexy Versus Sacro-spinous Fixation for Prolapse Treatment

NCT04878146 | Not Yet Recruiting DMC

• 1 other identifier: CHUV
• Study Type: interventional
• Target: 132
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Non inferiority of sacro-spinous fixation compared to sacrocolpopexy after 1 year

  Anatomical and symptomatic definition of success measured by validated questionnaires

  1 year

Secondary Outcomes (2)

• Operative time

  Immediately after operation

• Complications

  30 days

Study Arms (2)

Sacrocolpopexy

ACTIVE COMPARATOR

Used as the standard intervention for prolapse

Procedure: Subtotal hysterectomy; Procedure: Sacrocolpopexy

Sacro-spinous fixation

EXPERIMENTAL

To be demonstrated as non inferior

Procedure: Sacro-spinous fixation; Procedure: Subtotal hysterectomy

Interventions

Sacro-spinous fixation PROCEDURE

Uterine cervix will be attached to the sacro-spinous ligament

Also known as: Richter operation

Sacro-spinous fixation

Subtotal hysterectomy PROCEDURE

Done on both arms

Sacro-spinous fixation; Sacrocolpopexy

Sacrocolpopexy PROCEDURE

Uterine cervix is attached to sacral promontory with two synthetic meshes

Sacrocolpopexy

Eligibility Criteria

• Age: 30 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who:
• Have symptomatic prolapse, degree ≥ 2
• Want surgical management
• Accept subtotal hysterectomy
• Accept the idea of being in the arm of the study, which involves the placement of prosthetic material
• After explaining and reading the information sheet, have understood and signed the consent form

You may not qualify if:

• Refuse hysterectomy
• Refuse the idea of having prosthetic material implanted
• Prefer conservative management
• Have insufficient understanding of French
• Still wish a pregnancy
• Are not in a condition to withstand surgery of this type

Sponsors & Collaborators

• Centre Hospitalier Universitaire Vaudois: lead

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Chahin Achtari, MD

CONTACT

+41213143237; chahin.achtari@chuv.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Single blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: May 4, 2021
• First Posted: May 7, 2021
• Study Start: July 1, 2021
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2028
• Last Updated: May 7, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share