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

NCT03113513 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 312

Last updated 2024-01-23

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Medical University of Graz

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-05-01
Primary Completion
2025-04-30
Completion
2025-04-30

Countries

  • Austria

Study Locations

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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 NCT03113513 on ClinicalTrials.gov