Robotic-assisted Laparoscopic Sacrocolpopexy

Robotic-assisted Laparoscopic Sacrocolpopexy: A Feasibility Study

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

Study Overview

• Status: Completed
• Conditions: Pelvic Organ Prolapse
• Intervention / Treatment: Procedure: Robotic-assisted laparoscopic sacrocolpopexy; Procedure: Open sacrocolpopexy

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: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United States
  • California
    • Orange, California, United States, 92868
      • University of California, Irvine Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Female urogynecology patient with symptomatic apical prolapse

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Robotic Sacrocolpopexy Group; laparoscopic mesh augmented prolapse repair for post-hysterectomy prolapse repair using the Da Vinci robot	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 Names: DaVinci Robotic System
Open Sacrocolpopexy Group; matched cohort that underwent mesh augmented prolapse repair for post-hysterectomy prolapse performed via open laparotomy	Procedure: Open sacrocolpopexy; mesh augmented repair for post-hysterectomy prolapse performed via open laparotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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, estimated blood loss, UTI, duration-of stay	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	validated questionnaires	2 Years

Collaborators and Investigators

• Sponsor: University of California, Irvine
• Investigators: Principal Investigator: Felicia Lane, M.D., University of California, Irvine

Study record dates

Study Major Dates

• Study Start: May 1, 2007
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: December 21, 2007
• First Submitted That Met QC Criteria: December 26, 2007
• First Posted (Estimated): December 27, 2007

Study Record Updates

• Last Update Posted (Actual): August 23, 2023
• Last Update Submitted That Met QC Criteria: August 19, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Pelvic organ prolapse; Robotic-assisted laparoscopic sacrocolpopexy; Post hysterectomy prolapse; Symptomatic apical prolapse of stage II or >
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: 20054606