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

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ClinicalTrials.gov Identifier: NCT03034499
Recruitment Status : Completed
First Posted : January 27, 2017
Last Update Posted : June 11, 2019
Sponsor:
Information provided by (Responsible Party):
ROY LAUTERBACH MD, Rambam Health Care Campus

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:

  1. Via single-port.
  2. Via multi-port.

Condition or disease Intervention/treatment Phase
Pelvic Organ Prolapse Procedure: Single-port sacrocolpopexy Procedure: Multi-port sacrocolpopexy Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single Versus Multi-port Robotic Assisted Sacrocolpopexy for Repair of Vaginal Apex Prolapse
Actual Study Start Date : March 20, 2017
Actual Primary Completion Date : November 1, 2018
Actual Study Completion Date : April 1, 2019

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female patients.
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03034499


Locations
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Israel
Rambam health care campus
Haifa, Israel
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
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Principal Investigator: Roy Lauterbach, MD Rambam Health Care Campus

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Responsible Party: ROY LAUTERBACH MD, Principal investigator, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT03034499     History of Changes
Other Study ID Numbers: 0631-16-RMB
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: June 11, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical