Cohort Study of Bowel Function Following Robotic-assisted Laparoscopic Sacrocolpopexy
Study Details
Study Description
Brief Summary
Compare changes in bowel function before, 6 months and one year after Robotic-assisted laparoscopic sacral colpopexy. Compare objective anatomic outcomes before, 6 months and one year after Robotic-assisted laparoscopic sacral colpopexy.
Condition or Disease | Intervention/Treatment | Phase |
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Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Robotic-assisted sacrocolpopexy patients Patients who underwent robotic-assisted laparoscopic sacrocolpopexy between January 2007 and August 2011. |
Procedure: Robotic sacral colpopexy
Patients who underwent robotic assisted sacral colpopexy for the treatment of pelvic organ prolapse
Other Names:
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Outcome Measures
Primary Outcome Measures
- Changes in bowel function [preoperatively, 6 months, and one year post-surgery]
-Patients completed a validated colo-rectal-anal distress inventory (CARDI-8) at all 3 intervals. Specific complaints of splinting with defecation, excessive straining/pain with bowel movements, incomplete bowel emptying/obstructive symptoms and fecal incontinence were addressed. In addition, patients completed a validated colorectal-anal impact questionnaire (CRAIQ-7) at all 3 intervals. The CRAIQ-7 addresses bowel symptoms and the extend of quality of life impingement
Secondary Outcome Measures
- Objective anatomic outcomes [preoperatively, 6 months, and one year after surgery]
The pelvic organ prolapse quantification system (POP-Q)- an objective, validated, standardized method of quantifying the degree of pelvic organ prolapse present was used at all visits.
Eligibility Criteria
Criteria
Inclusion Criteria:
- All patients who underwent robotic assisted laparoscopic sacral colpopexy
Exclusion Criteria:
- Any other procedure for the treatment of pelvic organ prolapse
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Atlantic Health System | Morristown | New Jersey | United States | 07960 |
Sponsors and Collaborators
- Atlantic Health System
Investigators
- Principal Investigator: Patrick Culligan, MD, Atlantic Health System
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- R11-08-011