Laparoscopic Versus Robotic Assisted Laparoscopic Sacrocolpopexy for Vaginal Prolapse

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00551993
Recruitment Status : Completed
First Posted : November 1, 2007
Last Update Posted : February 19, 2014
Information provided by (Responsible Party):
The Cleveland Clinic

Brief Summary:
The purpose of this study is to conduct a trial of robotic assisted versus traditional laparoscopic sacrocolpopexy in the treatment of patients with vaginal prolapse.

Condition or disease Intervention/treatment Phase
Pelvic Organ Prolapse Procedure: robotic laparoscopic sacrocolpopexy Procedure: Laparoscopic Sacral Colpopexy Not Applicable

Detailed Description:

Although laparoscopic sacrocolpopexy (LscASC) has been demonstrated to yield comparable success rates to abdominal sacrocolpopexy (93-99%) for the surgical treatment of pelvic organ prolapse, it has not been widely adopted due to the increased operating time and steep learning curves associated with laparoscopic suturing and knot-tying. For these reasons, robotic systems have been advocated for this technique. The objective of this study is to conduct a prospective single-blinded randomized controlled trial of robotic assisted versus traditional LscASC in the treatment of patients with apical vaginal prolapse stages II-IV (prolapse from 1 cm proximal to the hymen to all points distal).

This is a prospective single-blinded randomized controlled trial. Robotic assisted LscASC will be performed using the da Vinci Surgical System (Intuitive Surgical Inc., Sunnyvale, CA, USA) in a similar manner as that described above for conventional laparoscopy. Data points recorded during the procedure will include: operating room time of entry and exit, time from incision to closure and time taken for the suturing aspect of the case. From this information, the operating room costs and anesthesia costs, i.e., the amount that a provider must pay for goods or services, will be calculated. Estimated blood loss, perioperative and post-operative complications, and number of days in the hospital will be studied as will cost-effectiveness and impact on HRQOL

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Conventional Laparoscopic Versus Robotic Assisted Laparoscopic Sacrocolpopexy: a Randomized Controlled Trial
Study Start Date : September 2006
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 2
Robotic Sacral Colpopexy
Procedure: robotic laparoscopic sacrocolpopexy
Da Vinci Robot
Active Comparator: 1
Laparoscopic Sacral Colpopexy
Procedure: Laparoscopic Sacral Colpopexy
Standard laparoscopy

Primary Outcome Measures :
  1. Primary outcome: operative time from incision to closure. [ Time Frame: Primary outcome: will be obtained immediately at the end of each procedure. ]

Secondary Outcome Measures :
  1. Secondary outcomes: perioperative complications, hospital costs and post-operative patient outcomes (anatomic outcomes on physical examination and patient satisfaction using validated condition specific quality of life measures). [ Time Frame: Secondary outcome: will be collected over the course of the first postoperative year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Women who are 21 years of age or greater
  • Status post hysterectomy with apical vaginal prolapse POPQ stages II-IV (prolapse from 1cm proximal to the hymen to all points distal) that desire laparoscopic surgical management.

Exclusion Criteria:

  • Patients that are not candidates for general anesthesia
  • Inability to consent
  • History of prior sacralcolpopexy
  • Suspicious adnexal masses or other factors that may indicate pelvic malignancy
  • History of pelvic inflammatory disease
  • Morbid obesity (body mass index greater than or equal to 40)
  • History of prior or need for concomitant rectopexy with sigmoid resection.

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 identifier (NCT number): NCT00551993

United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Principal Investigator: Marie Fidela M Paraiso, MD The Cleveland Clinic

Publications of Results:
Responsible Party: The Cleveland Clinic Identifier: NCT00551993     History of Changes
Other Study ID Numbers: 06-652
First Posted: November 1, 2007    Key Record Dates
Last Update Posted: February 19, 2014
Last Verified: February 2014

Keywords provided by The Cleveland Clinic:
vaginal prolapse
sacral colpopexy

Additional relevant MeSH terms:
Pelvic Organ Prolapse
Uterine Prolapse
Pathological Conditions, Anatomical
Uterine Diseases
Genital Diseases, Female