Robotic-assisted Laparoscopic Sacrocolpopexy

NCT00581334 | Completed DMC

• 1 other identifier: 20054606
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pelvic Organ Prolapse

Keywords

Pelvic organ prolapse; Robotic-assisted laparoscopic sacrocolpopexy; Post hysterectomy prolapse; Symptomatic apical prolapse of stage II or >

Outcome Measures

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, estimated blood loss, UTI, duration-of stay

  2 years

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.

  2 Years

Study Arms (2)

Robotic Sacrocolpopexy Group

laparoscopic mesh augmented prolapse repair for post-hysterectomy prolapse repair using the Da Vinci robot

Procedure: Robotic-assisted laparoscopic sacrocolpopexy

Open Sacrocolpopexy Group

matched cohort that underwent mesh augmented prolapse repair for post-hysterectomy prolapse performed via open laparotomy

Procedure: Open sacrocolpopexy

Interventions

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.

Also known as: DaVinci Robotic System

Robotic Sacrocolpopexy Group

Open sacrocolpopexy PROCEDURE

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

Open Sacrocolpopexy Group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female gynecology patients undergoing colpopexy.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Female urogynecology patient with symptomatic apical prolapse

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

University of California, Irvine Medical Center

Orange, California, 92868, United States

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Felicia Lane, M.D.

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Vice Chair of Obstetrics & Gynecology

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: December 27, 2007
• Study Start: May 1, 2007
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: August 23, 2023

Record last verified: 2023-08

Locations

US (1)