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Multi-centre, assessor-blinded, randomised controlled trial comparing physiotherapist-led behavioural intervention (including pelvic floor muscle training) to standard care, in the management of post-operative ileo-anal pouch patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention arm | Active Comparator | Pelvic floor and bowel behavioural training programme provided by physiotherapists over 2- 6 sessions within the 6 months following ileostomy closure for patients with an ileo-anal pouch |
|
| Standard arm | Placebo Comparator | Standard post-operative nursing and medical care provided in hospital clinic |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pelvic floor and bowel behavioural training | Behavioral | Physiotherapist-led pelvic floor muscle and bowel behavioural training |
|
| Measure | Description | Time Frame |
|---|---|---|
| Colo Rectal Functional Outcome Score (COREFO) | Between group comparison of outcome score - total and each of 5 domains | 6 and 12 months following ileostomy reversal |
| Measure | Description | Time Frame |
|---|---|---|
| Pouch Dysfunction score | Comparison of scores between groups | 1,3,6 and 12 months following ileostomy closure |
| Quality of Life Short-Form 36 (SF-36) | Quality of life SF-36 compared between groups - mental health domain, physical health domain and total score |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Global Impression of Improvement and Satisfaction | Between group comparison of patient rating of improvement and satisfaction on 7-point Likert Scales | 3,6 and 12 months following ileostomy closure |
| Adherence |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael A Kamm, MBBS,PhD | St Vincent's Hospital Melbourne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Vincent's Hospital | Fitzroy | Victoria | 3065 | Australia | ||
| Alfred Health |
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| Standard arm | Other | Standard medical and nursing care |
|
| Baseline, 3,6 and 12 months following ileostomy closure |
| Quality of Life EQ-5D | Scores from the EQ-5D will be compared between groups and quality adjusted life years (QALY) will be derived from EQ-5D. | Baseline,3,6 and 12 months following ileostomy closure |
| Inflammatory Bowel Disease Questionnaire (IBDQ) | Disease specific quality of life score comparing groups | Baseline,3,6 and 12 months following ileostomy closure |
| Hospital Anxiety and Depression Scale (HADs) | Psychological well being scores for anxiety and depression comparing groups | Baseline,3,6 and 12 months following ileostomy closure |
| Brief Illness Perception Questionnaire | Between group comparison of cognitive and emotional perceptions of illness | Baseline,3,6 and 12 months following ileostomy closure |
| Brief Cope | Between group comparison of coping styles and ability to cope with stress | Baseline,3,6 and 12 months following ileostomy closure |
| New General Self-Efficacy Scale | Between group comparison of confidence in ability to perform tasks and achieve goals | Baseline,3,6 and 12 months following ileostomy closure |
Patient rating of their level of adherence to the training programme
| 1,2,3,4,5 and 6 months following ileostomy closure |
| Pelvic floor muscle function | Transperineal measurements of displacement of puborectalis and change in anorectal angle with pelvic floor muscle contraction and with simulated defaecation | Baseline and 6 months following ileostomy closure |
| Cost to the healthcare system | Compare health care utilisation between groups | Baseline, 6 and 12 months following ileostomy closure |
| Prahran |
| Victoria |
| 3181 |
| Australia |