NCT05969067

Retroperitoneal Tunneling Versus Dissection Technique During Sacrocolpopexy

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: The University of Texas Medical Branch, Galveston · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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).

Detailed 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

Conditions

• Pelvic Organ Prolapse

Interventions

Type	Name	Description
PROCEDURE	Tunneling Technique during RA SCP	As described in the intervention arm above
PROCEDURE	Dissection Technique during RA SCP	As described in the intervention arm above

Timeline

• Start date: 2023-08-10
• Primary completion: 2024-08-01
• Completion: 2024-09-01
• First posted: 2023-08-01
• Last updated: 2025-04-10

Locations

1 site across 1 country: United States