NCT03113513

Comparison of Two Apical Repair Methods in Women Undergoing Repairs for Prolapse

Randomized Trial of Sacrospinous Ligament Fixation Versus McCall Culdoplasty in Women Undergoing Vaginal Hysterectomy and Repairs for Prolapse

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 312 (estimated)
• Sponsor: Medical University of Graz · Academic / Other
• Sex: Female
• Age: 35 Years – 80 Years
• Healthy volunteers: Accepted

Summary

To date no study has determined prospectively which technique is superior to prevent recurrent Pelvic Organ Prolapse (POP) after vaginal hysterectomy- a major unmet clinical need. The aim of the study is to determine objective anatomical recurrent prolapse after Sacrospinous Ligament Fixation (SLF) vs McCall.

Detailed description

The aim of the study is to determine objective anatomical recurrent prolapse after SLF vs McCall. The study is designed as a Randomized Controlled Trial (RCT). Primary study endpoint will be at 12 months, secondary study endpoint at 24 months. The following parameters will be evaluated after one year: anatomical outcome, Quality of Life (QoL), sexual health, reoperations, and complications.

Conditions

• Pelvic Organ Prolapse
• Surgery
• Quality of Life
• Complication

Interventions

Type	Name	Description
PROCEDURE	fixation of the vaginal apex	In the course of vaginal hysterectomy the vaginal cuff is either fixed to the sacrospinous ligament or to the uterosacral ligament.

Timeline

• Start date: 2016-05-01
• Primary completion: 2025-04-30
• Completion: 2025-04-30
• First posted: 2017-04-13
• Last updated: 2024-01-23

Locations

1 site across 1 country: Austria