Laparoscopic Versus Robotic Assisted Laparoscopic Sacrocolpopexy for Vaginal Prolapse
Conventional Laparoscopic Versus Robotic Assisted Laparoscopic Sacrocolpopexy: a Randomized Controlled Trial
1 other identifier
interventional
78
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2006
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2006
CompletedFirst Submitted
Initial submission to the registry
October 30, 2007
CompletedFirst Posted
Study publicly available on registry
November 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedFebruary 19, 2014
February 1, 2014
5.2 years
October 30, 2007
February 18, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Primary outcome: operative time from incision to closure.
Primary outcome: will be obtained immediately at the end of each procedure.
Secondary Outcomes (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).
Secondary outcome: will be collected over the course of the first postoperative year
Study Arms (2)
2
ACTIVE COMPARATORRobotic Sacral Colpopexy
1
ACTIVE COMPARATORLaparoscopic Sacral Colpopexy
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Related Publications (1)
Paraiso MFR, Jelovsek JE, Frick A, Chen CCG, Barber MD. Laparoscopic compared with robotic sacrocolpopexy for vaginal prolapse: a randomized controlled trial. Obstet Gynecol. 2011 Nov;118(5):1005-1013. doi: 10.1097/AOG.0b013e318231537c.
PMID: 21979458RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marie Fidela M Paraiso, MD
The Cleveland Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 30, 2007
First Posted
November 1, 2007
Study Start
September 1, 2006
Primary Completion
November 1, 2011
Study Completion
November 1, 2011
Last Updated
February 19, 2014
Record last verified: 2014-02