Robotic-assisted Laparoscopic Sacrocolpopexy

Completed

• Conditions: Pelvic Organ Prolapse
• Interventions: Procedure: Robotic-assisted laparoscopic sacrocolpopexy; Procedure: Open sacrocolpopexy

• Registration Number: NCT00581334
• Lead Sponsor: University of California, Irvine

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.

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2007-12-21
• Study First Submitted QC: 2007-12-26
• Study First Posted: 2007-12-27
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-19
• Last Update Posted: 2023-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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).	2 years	time, estimated blood loss, UTI, duration-of stay

Secondary Outcome Measures

Name	Time	Method
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	validated questionnaires

Trial Locations

Locations (1)

University of California, Irvine Medical Center; 🇺🇸 Orange, California, United States