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Comparison of Laparoscopic Pectopexy and Laparoscopic Lateral Suspension Techniques in Uterine-preserving Apical Prolapsus Repair

Pelvic Organ Prolapse Clinical Trial

Official title:
Comparison of Laparoscopic Pectopexy and Laparoscopic Lateral Suspension Techniques in Uterine-preserving Apical Prolapsus Repair

Clinical Trial Summary

The aim of the study will be to compare the laparoscopic pectopexy (LP) and laparoscopic lateral suspension (LLS) techniques in the management of uterine sparing apical prolapse (POP-Q >2) at 1 year and yearly up to 2 years.

Clinical Trial Description

Primary and secondary endpoints: Primary outcome measures will be the subjective cure of prolapse ("absence or presence of a bulge in the vagina"), objective success with anatomic absence of advanced prolapse at POP-Q sites Ba, C and Bp defined as less than 1 cm individually and as a total. Secondary outcome measures include all other parameters such as perioperative outcomes, patient satisfaction, quality of life outcomes, complications, scores on questionnaires, and reoperations. The study protocol will be submitted to the institutional review boards of every participating study site and written informed consent will be obtained from all participants on enrolment. Project design: The investigators will perform an international multicentre single-blind randomized controlled trial with participating our tertiary referral hospital. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05143658
Study type Interventional
Source Kanuni Sultan Suleyman Training and Research Hospital
Contact
Status Completed
Phase N/A
Start date December 6, 2021
Completion date March 4, 2024
View Details
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