The Role of Biofeedback in Improving Continence After Anterior Resection
Study Details
Study Description
Brief Summary
The purpose of this study is to determine whether biofeedback exercises improve anal continence after anterior resection for rectal cancer.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Detailed Description
See above
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Biofeedback Received feedback |
Behavioral: Biofeedback
Biofeedback sessions or biofeedback exercises
|
No Intervention: No biofeedback Did not received feedback |
Outcome Measures
Primary Outcome Measures
- Cleveland Clinic Incontinence (CCI) Score [1 year]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Rectosigmoid or rectal cancer
Exclusion Criteria:
- Inoperable
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Southampton General Hospital | Southampton | Hampshire | United Kingdom | SO16 6YD |
Sponsors and Collaborators
- University of Southampton
Investigators
- Principal Investigator: S A Pilkington, Southampton University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RHM GSU 0132
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Biofeedback | No Biofeedback |
---|---|---|
Arm/Group Description | Received feedback Biofeedback: Biofeedback sessions or biofeedback exercises | Did not received feedback |
Period Title: Overall Study | ||
STARTED | 61 | 60 |
COMPLETED | 46 | 43 |
NOT COMPLETED | 15 | 17 |
Baseline Characteristics
Arm/Group Title | Biofeedback | No Biofeedback | Total |
---|---|---|---|
Arm/Group Description | Received feedback Biofeedback: Biofeedback sessions or biofeedback exercises | Did not received feedback | Total of all reporting groups |
Overall Participants | 61 | 60 | 121 |
Age (years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [years] |
69
(10)
|
66
(9)
|
67
(10)
|
Sex: Female, Male (Count of Participants) | |||
Female |
23
37.7%
|
27
45%
|
50
41.3%
|
Male |
38
62.3%
|
33
55%
|
71
58.7%
|
Race and Ethnicity Not Collected (Count of Participants) | |||
Count of Participants [Participants] |
0
0%
|
||
Region of Enrollment (participants) [Number] | |||
United Kingdom |
61
100%
|
60
100%
|
121
100%
|
Incontinence (CCI) score (scores on a scale) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [scores on a scale] |
4
(5)
|
4
(5)
|
4
(5)
|
Outcome Measures
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 |
Outcome Measure Data
Analysis Population Description |
---|
Analyzed participants, less than the randomized participants |
Arm/Group Title | Biofeedback | No Biofeedback |
---|---|---|
Arm/Group Description | Received feedback Biofeedback: Biofeedback sessions or biofeedback exercises | Did not received feedback |
Measure Participants | 43 | 46 |
CCI final |
4.2
(4.2)
|
3.7
(3.5)
|
Adjusted CCI final |
1.2
(6.0)
|
-0.7
(5.5)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Biofeedback, No Biofeedback |
---|---|---|
Comments | CCI final | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.54 |
Comments | ||
Method | Regression, Linear | |
Comments |
Adverse Events
Time Frame | 1 year | |||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
Arm/Group Title | Biofeedback | No Biofeedback | ||
Arm/Group Description | Received feedback Biofeedback: Biofeedback sessions or biofeedback exercises | Did not received feedback | ||
All Cause Mortality |
||||
Biofeedback | No Biofeedback | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 1/61 (1.6%) | 4/60 (6.7%) | ||
Serious Adverse Events |
||||
Biofeedback | No Biofeedback | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 5/61 (8.2%) | 7/60 (11.7%) | ||
Gastrointestinal disorders | ||||
Rectovaginal fistula | 0/61 (0%) | 0 | 1/60 (1.7%) | 1 |
Surgical and medical procedures | ||||
Abdominoperineal excision | 2/61 (3.3%) | 2 | 2/60 (3.3%) | 2 |
Hartman procedures | 3/61 (4.9%) | 3 | 4/60 (6.7%) | 4 |
Other (Not Including Serious) Adverse Events |
||||
Biofeedback | No Biofeedback | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/61 (0%) | 0/60 (0%) |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Sophie A. Pilkington |
---|---|
Organization | University of Southampton |
Phone | +44 (0)23 8059 5058 |
rgioinfo@soton.ac.uk |
- RHM GSU 0132