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Laparoscopic Versus Robotic Assisted Laparoscopic Sacrocolpopexy for Vaginal Prolapse

Pelvic Organ Prolapse Clinical Trial

Official title:
Conventional Laparoscopic Versus Robotic Assisted Laparoscopic Sacrocolpopexy: a Randomized Controlled Trial

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00551993
Study type Interventional
Source The Cleveland Clinic
Contact
Status Completed
Phase N/A
Start date September 2006
Completion date November 2011
View Details
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