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Laparoscopic Versus Robotic Assisted Laparoscopic Sacrocolpopexy for Vaginal Prolapse

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00551993
First received: October 30, 2007
Last updated: March 17, 2012
Last verified: March 2012
History of Changes
  Purpose

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 Intervention
Pelvic Organ Prolapse
 Procedure: robotic laparoscopic sacrocolpopexy
Procedure: Laparoscopic Sacral Colpopexy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Conventional Laparoscopic Versus Robotic Assisted Laparoscopic Sacrocolpopexy: a Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • Primary outcome: operative time from incision to closure. [ Time Frame: Primary outcome: will be obtained immediately at the end of each procedure. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 78
Study Start Date: September 2006
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00551993

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

Publications:

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00551993     History of Changes
Other Study ID Numbers: 06-652
Study First Received: October 30, 2007
Last Updated: March 17, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:
laparoscopy
robot
vaginal prolapse
sacrocolpopexy
sacral colpopexy

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

ClinicalTrials.gov processed this record on May 16, 2013