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

Rambam Health Care Campus

Status: Completed

Conditions: Pelvic Organ Prolapse

Treatments: Procedure: Multi-port sacrocolpopexy; Procedure: Single-port sacrocolpopexy

Study type: Interventional

Funder types: Other

Identifiers

NCT03034499

0631-16-RMB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: Female

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Single-port sacrocolpopexy

Active Comparator group

Description:

Patients with vaginal apex prolapse randomized to undergo repair by single-port sacrocolpopexy.

Treatment:

Procedure: Single-port sacrocolpopexy

Multi-port sacrocolpopexy

Active Comparator group

Description:

Patients with vaginal apex prolapse randomized to undergo repair by multi- port sacrocolpopexy.

Treatment:

Procedure: Multi-port sacrocolpopexy