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Completed

NCT Number: NCT00551993

Laparoscopic Versus Robotic Assisted Laparoscopic Sacrocolpopexy for Vaginal Prolapse

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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Key information

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

robotic laparoscopic sacrocolpopexy

Procedure

Da Vinci Robot

Laparoscopic Sacral Colpopexy

Procedure

Standard laparoscopy

Primary outcomes

  1. Primary outcome: operative time from incision to closure.

    Time frame: 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).

    Time frame: Secondary outcome: will be collected over the course of the first postoperative year

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2011
Study completion
2011
First posted
Nov 1, 2007
Registry last updated
Feb 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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