Laparoscopic Versus Robotic Assisted Laparoscopic Sacrocolpopexy for Vaginal Prolapse

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2011-11-30

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Pelvic Organ Prolapse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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2

Robotic Sacral Colpopexy

Group Type ACTIVE_COMPARATOR

robotic laparoscopic sacrocolpopexy

Intervention Type PROCEDURE

Da Vinci Robot

1

Laparoscopic Sacral Colpopexy

Group Type ACTIVE_COMPARATOR

Laparoscopic Sacral Colpopexy

Intervention Type PROCEDURE

Standard laparoscopy

Interventions

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robotic laparoscopic sacrocolpopexy

Da Vinci Robot

Intervention Type PROCEDURE

Laparoscopic Sacral Colpopexy

Standard laparoscopy

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes