Robotic-assisted Laparoscopic Sacrocolpopexy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Felicia Lane, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00581334
First received: December 21, 2007
Last updated: July 18, 2013
Last verified: July 2013
  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

Resource links provided by NLM:


Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]

Enrollment: 20
Study Start Date: May 2007
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Robotic-assisted laparoscopic sacrocolpopexy
    4 abdominal incisions will be made: 1 infraumbilical port and 3 lateral ports. The peritoneum overlaying the sacrum is entered and the anterior longitudinal ligament is exposed. 3 permanent sutures are placed through the ligament at the S2-S3. Then a vaginal obturator is placed transvaginally and the apex of vagina is elevated into the operative field. The peritoneum overlying the anterior and posterior vaginal epithelium is reflected and the bladder is dissected off the underlying vagina to expose 4cm of apical vagina. 2 segments of polypropylene mesh are prepared and one segment is anchored along the anterior vagina with a series of interrupted permanent suture and the second segment is anchored along the posterior vagina. These 2 segments are brought together to the previously placed sutures within the anterior longitudinal ligament of the sacrum. The peritoneum is then closed over the graft complex and the pelvis irrigated. The 4 robotic ports are removed and the abdomen closed.
    Other Name: DaVinci Robotic System
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00581334

Locations
United States, California
University of California, Irvine Medical Center
Orange, California, United States, 92868
Sponsors and Collaborators
University of California, Irvine
Investigators
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
ClinicalTrials.gov Identifier: NCT00581334     History of Changes
Other Study ID Numbers: 2005-4606
Study First Received: December 21, 2007
Last Updated: July 18, 2013
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:
Pelvic Organ Prolapse
Prolapse
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on October 23, 2014