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

Study Overview
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Brief Summary
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A prospective randomized controlled study intended to compare the efficacy of 2 methods of robotic assisted sacrocolpopexy for the repair of vaginal apex prolapse: Via single-port. Via multi-port.

Detailed Description
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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: Via single-port. 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.

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

Conditions
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Pelvic Organ Prolapse

Intervention / Treatment
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* Procedure: Single-port sacrocolpopexy
* Procedure: Multi-port sacrocolpopexy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Single-port sacrocolpopexy<br>Patients with vaginal apex prolapse randomized to undergo repair by single-port sacrocolpopexy. | Procedure: Single-port sacrocolpopexy<br>* Single-port sacrocolpopexy surgery for the repair of vaginal apex prolapse.<br>|
| Active Comparator: Multi-port sacrocolpopexy<br>Patients with vaginal apex prolapse randomized to undergo repair by multi- port sacrocolpopexy. | Procedure: Multi-port sacrocolpopexy<br>* Multi-port sacrocolpopexy surgery for the repair of vaginal apex prolapse.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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