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Comparison of Posterior and Anterior Approach to Sacrospinous Ligament Apical Fixation - Randomized Controlled Trial

NCT04306250 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2024-04-02

No results posted yet for this study

Summary

Pelvic organ prolapse (POP) is a common problem among women. Apical prolapse (AP) is a prolapse of the uterus, or vaginal cuff, in women post hysterectomy.

Apical fixation to the sacrospinous ligament (SSLF) was first introduced in 1968 by K.RICHTER. .In a large review study, the subjective cure rate after SSLF ranged from 70 to 98%, while objective cure rate was 67-97%.

The success rates of SSLF in a randomized study comparing SSLF to uterosacral ligament fixation after two years were 63.1%. In women with combined apical and anterior wall prolapse, SSLF can be performed in two ways: anterior access through the anterior vaginal wall or posterior approach through the posterior vaginal wall.

A retrospective comparison of the two methods was performed, demonstrating some efficacy to the anterior approach over the posterior approach mainly in respect to the vaginal length.

From the literature review to date, no comparisons were made between the methods in a randomized controlled trial.

Objective: To compare the success rates between two approaches (anterior and posterior) for SSLF

Conditions

  • Pelvic Organ Prolapse
  • Surgical Procedure, Unspecified

Interventions

PROCEDURE

Apical prolapse fixation - anterior access

The surgery is done in anterior access

PROCEDURE

Apical prolapse fixation - posterior access

The surgery is done in posterior access

Sponsors & Collaborators

  • HaEmek Medical Center, Israel

    lead OTHER

Principal Investigators

  • meirav breverman, MD · haemek medical center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-07-09
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Israel

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 NCT04306250 on ClinicalTrials.gov