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The purpose of this study is to determine whether biofeedback exercises improve anal continence after anterior resection for rectal cancer.
See above
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biofeedback | Experimental | Received feedback |
|
| No biofeedback | No Intervention | Did not received feedback |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biofeedback | Behavioral | Biofeedback sessions or biofeedback exercises |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| S A Pilkington | Southampton University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southampton General Hospital | Southampton | Hampshire | SO16 6YD | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | Biofeedback | Received feedback Biofeedback: Biofeedback sessions or biofeedback exercises |
| FG001 | No Biofeedback | Did not received feedback |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Biofeedback | Received feedback Biofeedback: Biofeedback sessions or biofeedback exercises |
| BG001 | No Biofeedback | Did not received feedback |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Analyzed participants, less than the randomized participants | Posted | Mean | Standard Deviation | score on a scale | 1 year |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Biofeedback | Received feedback Biofeedback: Biofeedback sessions or biofeedback exercises |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominoperineal excision | Surgical and medical procedures | MedDRA (10.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sophie A. Pilkington | University of Southampton | +44 (0)23 8059 5058 | rgioinfo@soton.ac.uk |
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| D005242 | Fecal Incontinence |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| ID | Term |
|---|---|
| D001676 | Biofeedback, Psychology |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D001521 | Behavior Therapy |
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| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| 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. | Mean | Standard Deviation | scores on a scale |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| 1 |
| 61 |
| 5 |
| 61 |
| 0 |
| 61 |
| EG001 | No Biofeedback | Did not received feedback | 4 | 60 | 7 | 60 | 0 | 60 |
| Hartman procedures | Surgical and medical procedures | MedDRA (10.0) | Non-systematic Assessment |
|
| Rectovaginal fistula | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
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| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D011613 |
| Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D030141 | Feedback, Psychological |