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

June 9, 2019 updated by: ROY LAUTERBACH MD, Rambam Health Care Campus

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel
        • Rambam Health Care Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Single-port sacrocolpopexy
Patients with vaginal apex prolapse randomized to undergo repair by single-port sacrocolpopexy.
Procedure: Single-port sacrocolpopexy
Single-port sacrocolpopexy surgery for the repair of vaginal apex prolapse.
ACTIVE_COMPARATOR: Multi-port sacrocolpopexy
Patients with vaginal apex prolapse randomized to undergo repair by multi- port sacrocolpopexy.
Procedure: Multi-port sacrocolpopexy
Multi-port sacrocolpopexy surgery for the repair of vaginal apex prolapse.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of surgical time
Time Frame: 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.
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
Time Frame: 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.
Up to four months (2 weeks before surgery until 3 months post-surgery).
Comparison of surgical complications
Time Frame: 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.
Up to four months (2 weeks before surgery until 3 months post-surgery).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rambam Health Care Campus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 20, 2017

Primary Completion (ACTUAL)

November 1, 2018

Study Completion (ACTUAL)

April 1, 2019

Study Registration Dates

First Submitted

January 25, 2017

First Submitted That Met QC Criteria

January 26, 2017

First Posted (ESTIMATE)

January 27, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 11, 2019

Last Update Submitted That Met QC Criteria

June 9, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0631-16-RMB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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