Biofeedback, Colonic Pouches, Physical Therapy Modalities
Conditions
Keywords
Ileoanal pouch, pelvic floor exercise
Brief summary
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.
Interventions
BEHAVIORALPelvic floor and bowel behavioural training
Physiotherapist-led pelvic floor muscle and bowel behavioural training
OTHERStandard arm
Standard medical and nursing care
Sponsors
St Vincent's Hospital Melbourne
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Colo Rectal Functional Outcome Score (COREFO) | 6 and 12 months following ileostomy reversal | Between group comparison of outcome score - total and each of 5 domains |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pouch Dysfunction score | 1,3,6 and 12 months following ileostomy closure | Comparison of scores between groups |
| Quality of Life Short-Form 36 (SF-36) | Baseline, 3,6 and 12 months following ileostomy closure | Quality of life SF-36 compared between groups - mental health domain, physical health domain and total score |
| Quality of Life EQ-5D | Baseline,3,6 and 12 months following ileostomy closure | Scores from the EQ-5D will be compared between groups and quality adjusted life years (QALY) will be derived from EQ-5D. |
| Inflammatory Bowel Disease Questionnaire (IBDQ) | Baseline,3,6 and 12 months following ileostomy closure | Disease specific quality of life score comparing groups |
| Hospital Anxiety and Depression Scale (HADs) | Baseline,3,6 and 12 months following ileostomy closure | Psychological well being scores for anxiety and depression comparing groups |
| Brief Illness Perception Questionnaire | Baseline,3,6 and 12 months following ileostomy closure | Between group comparison of cognitive and emotional perceptions of illness |
| New General Self-Efficacy Scale | Baseline,3,6 and 12 months following ileostomy closure | Between group comparison of confidence in ability to perform tasks and achieve goals |
| Brief Cope | Baseline,3,6 and 12 months following ileostomy closure | Between group comparison of coping styles and ability to cope with stress |
Countries
Australia
Contacts
PRINCIPAL_INVESTIGATORMichael A Kamm, MBBS,PhD
St Vincent's Hospital Melbourne
Outcome results
None listed