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Completed

NCT Number: NCT00581334

Robotic-assisted Laparoscopic Sacrocolpopexy

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

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Key information

Conditions

Pelvic Organ Prolapse Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Prolapse

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of California, Irvine Medical Center

Orange, California, 92868, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Robotic-assisted laparoscopic sacrocolpopexy

Procedure

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 names: DaVinci Robotic System

Open sacrocolpopexy

Procedure

mesh augmented repair for post-hysterectomy prolapse performed via open laparotomy

Primary outcomes

  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

    time, estimated blood loss, UTI, duration-of stay

Secondary outcomes

  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

    validated questionnaires

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Registry information

Official study title

Robotic-assisted Laparoscopic Sacrocolpopexy: A Feasibility Study

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Dec 27, 2007
Registry last updated
Aug 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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