Robotic-Assisted Laparoscopic Sacrocolpopexy - Tabular View

Tracking Information

First Received Date ^ICMJE

December 21, 2007

Last Updated Date

June 11, 2009

Start Date ^ICMJE

May 2007

Estimated Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The primary outcomes are operative time, blood loss, complication rates, length of hospital stay, and cure. Objective cure can be measured using the pelvic organ prolapse quantification exam (POP-Q). [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00581334 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Secondary outcomes will measure the effects of the surgical repair using a series of questionnaires: SF-36, Pelvic Floor Distress Inventory which includes Pelvic Organ Prolapse Impact, Colo-Rectal-Anal Impact, and Urinary Impact Questionnaire. [ Time Frame: 2 Years ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Robotic-Assisted Laparoscopic Sacrocolpopexy

Official Title ^ICMJE

Robotic-Assisted Laparoscopic Sacrocolpopexy: A Feasibility Study

Brief Summary

Robotic-assisted Abdominal Sacrocolpopexy is both a feasible and safe method for apical prolapse repair of the vagina.

Detailed Description

Robotics offers many advantages over traditional laparoscopy: 1) intuitive movement of instruments, 2) "wristed instruments" with increased degrees of freedom, 3) enhanced 12X magnification, 4) 3-D depth perception, 5)tremor filtration, 6) enhanced surgeon comfort and ergonomics, and 7) a steeper learning curve. With robotic assistance, the surgeon can comfortably perform precise, repetitive motions, with greater dexterity and vision. To date, there have been a small number of published cases of laparoscopic sacrocolpopexy and two cases of series utilizing robotic-assisteance. There have been no prospective, randomized, controlled trials comparing either of these modalities to conventional abdominal sacrocolpopexy.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Single Group Assignment

Condition ^ICMJE

Pelvic Organ Prolapse

Intervention ^ICMJE

Procedure: Robotic-assisted laparoscopic sacrocolpopexy

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

June 2011

Estimated Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Non-pregnant women
Age >18 years
Eligible for sacrocolpopexy
Prior hysterectomy
Stage II or greater post hysterectomy vault prolapse
Satisfied parity
Patients electing for an abdominal repair to posthysterectomy vault prolapse

Exclusion Criteria:

Prisoners
Cognitively impaired adults
Not medically stable to undergo laparoscopic or abdominal surgery
Previous pelvic/vaginal radiation
Participants electing to proceed with a vaginal repair of vaginal vault prolapse
Participants electing to proceed with the traditional abdominal sacrocolpopexy
History of recurrent vaginal infections
Known urologic and/or gynecologic cancer

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00581334

Responsible Party

Felicia Lane, Associate Professor, University of California, Irvine Medical Center

Study ID Numbers ^ICMJE

2005-4606

Study Sponsor ^ICMJE

University of California, Irvine

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Felicia Lane, M.D.

University of California, Irvine Medical Center

Information Provided By

University of California, Irvine

Verification Date

June 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP