Robotic-assisted Laparoscopic Sacrocolpopexy

NCT ID: NCT00581334

Last Updated: 2023-08-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2012-06-30

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.

Conditions

Pelvic Organ Prolapse

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Robotic Sacrocolpopexy Group

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

Robotic-assisted laparoscopic sacrocolpopexy

Intervention Type: 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.

Open Sacrocolpopexy Group

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

Open sacrocolpopexy

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: PROCEDURE

Open sacrocolpopexy

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

Intervention Type: PROCEDURE

Other Intervention Names

DaVinci Robotic System

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

Felicia Lane

Professor and Vice Chair of Obstetrics & Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Felicia Lane, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, Irvine

Locations

University of California, Irvine Medical Center

Orange, California, United States

Countries

United States

Other Identifiers

20054606

Identifier Type: -

Identifier Source: org_study_id