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| Sponsored by: |
University of California, Irvine |
|---|---|
| Information provided by: | University of California, Irvine |
| ClinicalTrials.gov Identifier: | NCT00581334 |
Purpose
Robotic-assisted Abdominal Sacrocolpopexy is both a feasible and safe method for apical prolapse repair of the vagina.
| Condition | Intervention |
|---|---|
|
Pelvic Organ Prolapse |
Procedure: Robotic-assisted laparoscopic sacrocolpopexy |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment |
| Official Title: | Robotic-Assisted Laparoscopic Sacrocolpopexy: A Feasibility Study |
| Estimated Enrollment: | 10 |
| Study Start Date: | May 2007 |
| Estimated Study Completion Date: | June 2011 |
| Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| University of California, Irvine Medical Center | |
| Orange, California, United States, 92868 | |
| Principal Investigator: | Felicia Lane, M.D. | University of California, Irvine Medical Center |
More Information
| Responsible Party: | University of California, Irvine Medical Center ( Felicia Lane, Associate Professor ) |
| Study ID Numbers: | 2005-4606 |
| Study First Received: | December 21, 2007 |
| Last Updated: | June 11, 2009 |
| ClinicalTrials.gov Identifier: | NCT00581334 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Pelvic organ prolapse Robotic-assisted laparoscopic sacrocolpopexy Post hysterectomy prolapse Symptomatic post hysterectomy prolapse of stage II or greater |
|
Pathological Conditions, Anatomical Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases |
Rectal Diseases Prolapse Rectal Prolapse |
|
Pathological Conditions, Anatomical Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases |
Rectal Diseases Prolapse Rectal Prolapse |