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

Pelvic Organ Prolapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03034499
• Other study ID #: 0631-16-RMB
• Status: Completed
• Phase: N/A
• Start date: March 20, 2017
• Est. completion date: April 1, 2019

Study information

• Verified date: June 2019
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: April 1, 2019
• Est. primary completion date: November 1, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

Procedure:
• Single-port sacrocolpopexy
Single-port sacrocolpopexy surgery for the repair of vaginal apex prolapse.
• Multi-port sacrocolpopexy
Multi-port sacrocolpopexy surgery for the repair of vaginal apex prolapse.

Locations

Country	Name	City	State
Israel	Rambam health care campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).
Secondary	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).