Robotic-assisted Laparoscopic Sacrocolpopexy: A Feasibility Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pelvic Organ Prolapse
- Sponsor
- University of California, Irvine
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- 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).
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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-assistance. There have been no prospective, randomized, controlled trials comparing either of these modalities to conventional abdominal sacrocolpopexy.
Investigators
Felicia Lane
Professor and Vice Chair of Obstetrics & Gynecology
University of California, Irvine
Eligibility Criteria
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
Outcomes
Primary Outcomes
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
time, estimated blood loss, UTI, duration-of stay
Secondary Outcomes
- 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.(2 Years)