Aged, Fecal Incontinence, Rectal Neoplasms
Conditions
Keywords
Rectal neoplasms, Biofeedback (Psychology), Fecal Incontinence, Aged, Anterior resection
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
Interventions
BEHAVIORALBiofeedback
Biofeedback sessions or biofeedback exercises
Sponsors
University of Southampton
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Rectosigmoid or rectal cancer
Exclusion criteria
* Inoperable
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Biofeedback Received feedback
Biofeedback: Biofeedback sessions or biofeedback exercises | 61 |
| No Biofeedback Did not received feedback | 60 |
| Total | 121 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 9 | 13 |
| Overall Study | Withdrawal by Subject | 6 | 4 |
Baseline characteristics
| Characteristic | Biofeedback | No Biofeedback | Total |
|---|---|---|---|
| Age, Continuous | 69 years STANDARD_DEVIATION 10 | 66 years STANDARD_DEVIATION 9 | 67 years STANDARD_DEVIATION 10 |
| Incontinence (CCI) score | 4 scores on a scale STANDARD_DEVIATION 5 | 4 scores on a scale STANDARD_DEVIATION 5 | 4 scores on a scale STANDARD_DEVIATION 5 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United Kingdom | 61 participants | 60 participants | 121 participants |
| Sex: Female, Male Female | 23 Participants | 27 Participants | 50 Participants |
| Sex: Female, Male Male | 38 Participants | 33 Participants | 71 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 61 | 4 / 60 |
| other Total, other adverse events | 0 / 61 | 0 / 60 |
| serious Total, serious adverse events | 5 / 61 | 7 / 60 |
Outcome results
Primary
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.
Time frame: 1 year
Population: Analyzed participants, less than the randomized participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Biofeedback | Cleveland Clinic Incontinence (CCI) Score | CCI final | 4.2 score on a scale | Standard Deviation 4.2 |
| Biofeedback | Cleveland Clinic Incontinence (CCI) Score | Adjusted CCI final | 1.2 score on a scale | Standard Deviation 6 |
| No Biofeedback | Cleveland Clinic Incontinence (CCI) Score | CCI final | 3.7 score on a scale | Standard Deviation 3.5 |
| No Biofeedback | Cleveland Clinic Incontinence (CCI) Score | Adjusted CCI final | -0.7 score on a scale | Standard Deviation 5.5 |
Comparison: CCI finalp-value: 0.54Regression, Linear