Back to resultsThe Role of Biofeedback in Improving Continence After Anterior Resection
Primary Purpose
Rectal Neoplasms, Fecal Incontinence, Aged
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Biofeedback
Sponsored by
About this trial
This is an interventional prevention trial for Rectal Neoplasms focused on measuring Rectal neoplasms, Biofeedback (Psychology), Fecal Incontinence, Aged, Anterior resection
Eligibility Criteria
Inclusion Criteria:
- Rectosigmoid or rectal cancer
Exclusion Criteria:
- Inoperable
Sites / Locations
- Southampton General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Biofeedback
No biofeedback
Arm Description
Received feedback
Did not received feedback
Outcomes
Primary Outcome Measures
Cleveland Clinic Incontinence (CCI) Score
The Cleveland Clinic incontinence score (CCI) is an anal incontinence severity score. It is easy to use and gives the patient a score of 0 to 20, where zero equates to perfect continence and twenty equates to complete anal incontinence.
Secondary Outcome Measures
Full Information
NCT ID
NCT00515853
First Posted
August 10, 2007
Last Updated
January 3, 2022
Sponsor
University of Southampton
1. Study Identification
Unique Protocol Identification Number
NCT00515853
Brief Title
The Role of Biofeedback in Improving Continence After Anterior Resection
Official Title
The Role of Biofeedback in Improving Continence After Anterior Resection
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
November 27, 2006 (Actual)
Primary Completion Date
May 13, 2010 (Actual)
Study Completion Date
May 13, 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Southampton
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine whether biofeedback exercises improve anal continence after anterior resection for rectal cancer.
Detailed Description
See above
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Neoplasms, Fecal Incontinence, Aged
Keywords
Rectal neoplasms, Biofeedback (Psychology), Fecal Incontinence, Aged, Anterior resection
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
121 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Biofeedback
Arm Type
Experimental
Arm Description
Received feedback
Arm Title
No biofeedback
Arm Type
No Intervention
Arm Description
Did not received feedback
Intervention Type
Behavioral
Intervention Name(s)
Biofeedback
Intervention Description
Biofeedback sessions or biofeedback exercises
Primary Outcome Measure Information:
Title
Cleveland Clinic Incontinence (CCI) Score
Description
The Cleveland Clinic incontinence score (CCI) is an anal incontinence severity score. It is easy to use and gives the patient a score of 0 to 20, where zero equates to perfect continence and twenty equates to complete anal incontinence.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Rectosigmoid or rectal cancer
Exclusion Criteria:
Inoperable
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
S A Pilkington
Organizational Affiliation
Southampton University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southampton General Hospital
City
Southampton
State/Province
Hampshire
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Role of Biofeedback in Improving Continence After Anterior Resection
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