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Robotic-assisted Laparoscopic Sacrocolpopexy

University of California Irvine (UCI) logo

University of California Irvine (UCI)

Status

Completed

Conditions

Pelvic Organ Prolapse

Treatments

Procedure: Robotic-assisted laparoscopic sacrocolpopexy
Procedure: Open sacrocolpopexy

Study type

Observational

Funder types

Other

Identifiers

NCT00581334
20054606

Details and patient eligibility

About

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

Full 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.

Enrollment

20 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

20 participants in 2 patient groups

Robotic Sacrocolpopexy Group
Description:
laparoscopic mesh augmented prolapse repair for post-hysterectomy prolapse repair using the Da Vinci robot
Treatment:
Procedure: Robotic-assisted laparoscopic sacrocolpopexy
Open Sacrocolpopexy Group
Description:
matched cohort that underwent mesh augmented prolapse repair for post-hysterectomy prolapse performed via open laparotomy
Treatment:
Procedure: Open sacrocolpopexy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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