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NCT01618292 Clinical Trial

Cohort Study of Bowel Function Following Robotic-assisted Laparoscopic Sacrocolpopexy

Irritable Bowel Syndrome Clinical Trial

Official title:
Cohort Study of Bowel Function Following Robotic-assisted Laparoscopic Sacrocolpopexy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01618292
Other study ID # R11-08-011
Secondary ID
Status Completed
Phase N/A
First received June 11, 2012
Last updated January 27, 2014
Start date January 2007
Est. completion date August 2012

Study information
Verified date January 2014
Source Atlantic Health System
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 393
Est. completion date August 2012
Est. primary completion date August 2012
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

- All patients who underwent robotic assisted laparoscopic sacral colpopexy

Exclusion Criteria:

- Any other procedure for the treatment of pelvic organ prolapse

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Procedure:
• Robotic sacral colpopexy
Patients who underwent robotic assisted sacral colpopexy for the treatment of pelvic organ prolapse

Locations
Country Name City State
United States Atlantic Health System Morristown New Jersey

Sponsors (1)
Lead Sponsor Collaborator
Atlantic Health System

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Changes in bowel function -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 preoperatively, 6 months, and one year post-surgery No
Secondary Objective anatomic outcomes 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. preoperatively, 6 months, and one year after surgery No
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