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

Primary Purpose

Pelvic Organ Prolapse

Status

Completed

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

Single-port sacrocolpopexy

Multi-port sacrocolpopexy

About this trial

This is an interventional treatment trial for Pelvic Organ Prolapse

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

Rambam health care campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Single-port sacrocolpopexy

Multi-port sacrocolpopexy

Arm Description

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

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

Outcomes

Primary Outcome Measures

Comparison of surgical time

Comparison of surgical time in single versus multi-port robotic assisted sacrocolpopexy.

Secondary Outcome Measures

Comparison of surgical success

Comparison of surgical success in single versus multi-port robotic assisted sacrocolpopexy.

Comparison of surgical complications

Comparison of surgical complications (including bleeding and post operative pain) in single versus multi-port robotic assisted sacrocolpopexy.

Full Information

NCT ID

NCT03034499

First Posted

January 25, 2017

Last Updated

June 9, 2019

Sponsor

Rambam Health Care Campus

1. Study Identification

Unique Protocol Identification Number

NCT03034499

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2019

Overall Recruitment Status

Completed

Study Start Date

March 20, 2017 (Actual)

Primary Completion Date

November 1, 2018 (Actual)

Study Completion Date

April 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Rambam Health Care Campus

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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: Via single-port. 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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pelvic Organ Prolapse

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Single-port sacrocolpopexy

Arm Type

Active Comparator

Arm Description

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

Arm Title

Multi-port sacrocolpopexy

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Single-port sacrocolpopexy

Intervention Description

Single-port sacrocolpopexy surgery for the repair of vaginal apex prolapse.

Intervention Type

Procedure

Intervention Name(s)

Multi-port sacrocolpopexy

Intervention Description

Multi-port sacrocolpopexy surgery for the repair of vaginal apex prolapse.

Primary Outcome Measure Information:

Title

Comparison of surgical time

Description

Comparison of surgical time in single versus multi-port robotic assisted sacrocolpopexy.

Time Frame

Up to four months (2 weeks before surgery until 3 months post-surgery).

Secondary Outcome Measure Information:

Title

Comparison of surgical success

Description

Comparison of surgical success in single versus multi-port robotic assisted sacrocolpopexy.

Time Frame

Up to four months (2 weeks before surgery until 3 months post-surgery).

Title

Comparison of surgical complications

Description

Comparison of surgical complications (including bleeding and post operative pain) in single versus multi-port robotic assisted sacrocolpopexy.

Time Frame

Up to four months (2 weeks before surgery until 3 months post-surgery).

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

Female patients.

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Roy Lauterbach, MD

Organizational Affiliation

Rambam Health Care Campus

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rambam health care campus

City

Haifa

Country

Israel

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

31589864

Citation

Matanes E, Boulus S, Lauterbach R, Amit A, Weiner Z, Lowenstein L. Robotic laparoendoscopic single-site compared with robotic multi-port sacrocolpopexy for apical compartment prolapse. Am J Obstet Gynecol. 2020 Apr;222(4):358.e1-358.e11. doi: 10.1016/j.ajog.2019.09.048. Epub 2019 Oct 4.

Results Reference

derived

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

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