Robotic-assisted Laparoscopic Sacrocolpopexy
Recruitment status was Active, not recruiting
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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: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Robotic-assisted Laparoscopic Sacrocolpopexy: A Feasibility Study |
- 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 ]
- 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 ]
| 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) |
-
Procedure: Robotic-assisted laparoscopic sacrocolpopexy
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-assistance. 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:
- 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
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 |
More Information
No publications provided
| Responsible Party: | Felicia Lane, Associate Professor, University of California, Irvine Medical Center |
| ClinicalTrials.gov Identifier: | NCT00581334 History of Changes |
| Other Study ID Numbers: | 2005-4606 |
| Study First Received: | December 21, 2007 |
| Last Updated: | May 6, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of California, Irvine:
|
Pelvic organ prolapse Robotic-assisted laparoscopic sacrocolpopexy Post hysterectomy prolapse Symptomatic post hysterectomy prolapse of stage II or greater |
Additional relevant MeSH terms:
|
Prolapse Pelvic Organ Prolapse Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on May 16, 2013