Laparoscopic Versus Robotic Assisted Laparoscopic Sacrocolpopexy for Vaginal Prolapse

Sponsor

The Cleveland Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT00551993

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

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 :

Sep 1, 2006

Actual Primary Completion Date :

Nov 1, 2011

Actual Study Completion Date :

Nov 1, 2011

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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). [Secondary outcome: will be collected over the course of the first postoperative year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

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.