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Completed

NCT Number: NCT03034499

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

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.

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Key information

Conditions

Pelvic Organ Prolapse Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Prolapse

Age range

30 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Rambam health care campus

Haifa, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Single-port sacrocolpopexy

Procedure

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

Multi-port sacrocolpopexy

Procedure

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Rambam Health Care Campus

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Jan 27, 2017
Registry last updated
Jun 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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