Robotic-assisted Laparoscopic Sacrocolpopexy

Pelvic Organ Prolapse Clinical Trial

Official title:

Robotic-assisted Laparoscopic Sacrocolpopexy: A Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00581334
• Other study ID #: 20054606
• Status: Completed
• Start date: May 2007
• Est. completion date: June 2012

Study information

• Verified date: August 2023
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

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.
• Open sacrocolpopexy
mesh augmented repair for post-hysterectomy prolapse performed via open laparotomy

Locations

Country	Name	City	State
United States	University of California, Irvine Medical Center	Orange	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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