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Retroperitoneal Tunneling Versus Dissection Technique During Sacrocolpopexy

Pelvic Organ Prolapse Clinical Trial

Official title:
Comparing Retroperitoneal Tunneling Versus Dissection Technique During Robotic Assisted Sacrocolpopexy for Pelvic Organ Prolapse

Clinical Trial Summary

The purpose of this study is to compare operative time, patient reported outcomes, surgical complications, and surgical outcomes between the tunneling versus dissection technique during robotic assisted sacrocolpopexy (RA SCP).

Clinical Trial Description

Women with symptomatic, stage II to IV POP who plan RA SCP at UTMB Health will be approached to participate. Using the study protocol inclusion and exclusion criteria, patient's eligibility will be determined. All eligible subjects will provide the written informed consent before any research data is collected. All screening assessments will be completed at a preoperative, in-person, clinic visit, and within 60 days of surgery. The subject will then undergo randomization to tunneling versus dissection technique during RA SCP with the total sample size of 40 female subjects (20 per group). Concomitant procedures for POP or urinary incontinence are permitted and will be based upon the operating surgeons' standard clinical practice and best clinical judgement. Subsequently, the subject will have postoperative follow up at 2 weeks, 6 weeks and 3 months ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05969067
Study type Interventional
Source The University of Texas Medical Branch, Galveston
Contact
Status Active, not recruiting
Phase N/A
Start date August 10, 2023
Completion date May 1, 2025
View Details
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