Robotic-assisted Laparoscopic Sacrocolpopexy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00581334
Recruitment Status : Completed
First Posted : December 27, 2007
Last Update Posted : July 22, 2013
Information provided by (Responsible Party):
Felicia Lane, University of California, Irvine

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

Condition or disease Intervention/treatment Phase
Pelvic Organ Prolapse Procedure: Robotic-assisted laparoscopic sacrocolpopexy Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Robotic-assisted Laparoscopic Sacrocolpopexy: A Feasibility Study
Study Start Date : May 2007
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00581334

United States, California
University of California, Irvine Medical Center
Orange, California, United States, 92868
Sponsors and Collaborators
University of California, Irvine
Principal Investigator: Felicia Lane, M.D. University of California, Irvine

Responsible Party: Felicia Lane, Associate Professor, University of California, Irvine Identifier: NCT00581334     History of Changes
Other Study ID Numbers: 2005-4606
First Posted: December 27, 2007    Key Record Dates
Last Update Posted: July 22, 2013
Last Verified: July 2013

Keywords provided by Felicia Lane, 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
Pathological Conditions, Anatomical