Single Versus Multi-port Robotic Assisted Sacrocolpopexy for Repair of Vaginal Apex Prolapse

Not Applicable

Completed

• Conditions: Pelvic Organ Prolapse
• Interventions: Procedure: Single-port sacrocolpopexy; Procedure: Multi-port sacrocolpopexy

• Registration Number: NCT03034499
• Lead Sponsor: Rambam Health Care Campus

Brief Summary

A prospective randomized controlled study intended to compare the efficacy of 2 methods of robotic assisted sacrocolpopexy for the repair of vaginal apex prolapse:

1. Via single-port.

2. Via multi-port.

Detailed Description

One hundred female patients diagnosed with vaginal apex prolapse will be recruited to a prospective randomized controlled study intended to compare the efficacy of 2 methods of robotic assisted sacrocolpopexy:

1. Via single-port.

2. Via multi-port. The patients will be evaluated and randomized 2 weeks before the expected date of surgery during which eligibility will be examined.

Patients' electronic files will be reviewed post operatively to acquire information regarding medical history, prolapse scores, surgical information, anesthesia information and surgical complications.

Patients will have 3 week and 3 month post operative follow-up sessions to determine surgical success, late complications and patient satisfaction.

Study Timeline

• Study First Submitted: 2017-01-25
• Study First Submitted QC: 2017-01-26
• Study First Posted: 2017-01-27
• Study Start: 2017-03-20
• Primary Completion: 2018-11-01
• Study Completion: 2019-04-01
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-09
• Last Update Posted: 2019-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

• Female patients with vaginal apex prolapse that are eligible for repair by sacrocolpopexy.

Exclusion Criteria

• Patients after previous hysterectomy.
• Patients after previous surgical procedures for prolapse repair.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single-port sacrocolpopexy	Single-port sacrocolpopexy	Patients with vaginal apex prolapse randomized to undergo repair by single-port sacrocolpopexy.
Multi-port sacrocolpopexy	Multi-port sacrocolpopexy	Patients with vaginal apex prolapse randomized to undergo repair by multi- port sacrocolpopexy.

Primary Outcome Measures

Name	Time	Method
Comparison of surgical time	Up to four months (2 weeks before surgery until 3 months post-surgery).	Comparison of surgical time in single versus multi-port robotic assisted sacrocolpopexy.

Secondary Outcome Measures

Name	Time	Method
Comparison of surgical success	Up to four months (2 weeks before surgery until 3 months post-surgery).	Comparison of surgical success in single versus multi-port robotic assisted sacrocolpopexy.
Comparison of surgical complications	Up to four months (2 weeks before surgery until 3 months post-surgery).	Comparison of surgical complications (including bleeding and post operative pain) in single versus multi-port robotic assisted sacrocolpopexy.

Trial Locations

Locations (1)

Rambam health care campus; 🇮🇱 Haifa, Israel