Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2017-04-20
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Intervention arm
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
Pelvic floor and bowel behavioural training
Physiotherapist-led pelvic floor muscle and bowel behavioural training
Standard arm
Standard post-operative nursing and medical care provided in hospital clinic
Standard arm
Standard medical and nursing care
Interventions
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Pelvic floor and bowel behavioural training
Physiotherapist-led pelvic floor muscle and bowel behavioural training
Standard arm
Standard medical and nursing care
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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St Vincent's Hospital Melbourne
OTHER
Responsible Party
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Angela Khera
Senior Clinician Physiotherapist
Principal Investigators
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Michael A Kamm, MBBS,PhD
Role: PRINCIPAL_INVESTIGATOR
St Vincent's Hospital Melbourne
Locations
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St Vincent's Hospital
Fitzroy, Victoria, Australia
Alfred Health
Prahran, Victoria, Australia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HREC/16/SVHM/214
Identifier Type: -
Identifier Source: org_study_id
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