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CompletedNCT00581334

Robotic-assisted Laparoscopic Sacrocolpopexy

Robotic-assisted Laparoscopic Sacrocolpopexy: A Feasibility Study

Status
Completed
Phase
Study type
Observational
Enrollment
20 (actual)
Sponsor
University of California, Irvine · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
PROCEDURERobotic-assisted laparoscopic sacrocolpopexy4 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.
PROCEDUREOpen sacrocolpopexymesh augmented repair for post-hysterectomy prolapse performed via open laparotomy

Timeline

Start date
2007-05-01
Primary completion
2012-06-01
Completion
2012-06-01
First posted
2007-12-27
Last updated
2023-08-23

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00581334. Inclusion in this directory is not an endorsement.

Robotic-assisted Laparoscopic Sacrocolpopexy (NCT00581334) · Clinical Trials Directory