Rehabilitation After Ileo-anal Pouch Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Behavioural Treatment Following Ileo-Anal Pouch Formation:

Conditions
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Colonic Pouches, Physical Therapy Modalities, Biofeedback

Intervention / Treatment
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* Behavioral: Pelvic floor and bowel behavioural training
* Other: Standard arm


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Proven (documented) history of Ulcerative Colitis or Familial Adenomatous Polyposis Proctocolectomy and awaiting ileo-anal pouch formation or have had ileo-anal pouch created and are waiting for stoma reversal or have had stoma reversal within the last 60 days Exclusion Criteria: Primary sclerosing cholangitis Significant medical or psychiatric comorbidity that in the opinion of the investigators would interfere with bowel function or adherence to the protocol Clinically significant narcotic or substance abuse that in the opinion of the investigators would interfere with bowel function or adherence to the protocol Recognised eating disorder Non- English speaking or illiterate Pregnancy Current participant in another trial

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention arm<br>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 | Behavioral: Pelvic floor and bowel behavioural training<br>* Physiotherapist-led pelvic floor muscle and bowel behavioural training<br>|
| Placebo Comparator: Standard arm<br>Standard post-operative nursing and medical care provided in hospital clinic | Other: Standard arm<br>* Standard medical and nursing care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ileoanal pouch, pelvic floor exercise