Colonic PouchesRAPNCT03148600
Rehabilitation After Ileo-anal Pouch Surgery
A study testing Pelvic floor and bowel behavioural training and Standard arm in people with Colonic Pouches and Physical Therapy Modalities, run by St Vincent's Hospital Melbourne at 2 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colonic Pouches, Physical Therapy Modalities, Biofeedback
- What is being tested?
- Pelvic floor and bowel behavioural training and Standard arm
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 2 sitesAustralia
- Study dates
- 20 Apr 2017to 19 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
St Vincent's Hospital
Fitzroy, Victoria, 3065
Alfred Health
Prahran, Victoria, 3181
About this study
Official title: Behavioural Treatment Following Ileo-Anal Pouch Formation:
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.
- Conditions
- Colonic Pouches, Physical Therapy Modalities, Biofeedback
- Being tested
- Pelvic floor and bowel behavioural training, Standard arm
- Keywords
- Ileoanal pouch, pelvic floor exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic floor and bowel behavioural trainingBehavioural
Physiotherapist-led pelvic floor muscle and bowel behavioural training
Standard armOther
Standard medical and nursing care
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Pelvic floor and bowel behavioural training |
| Standard arm | Placebo comparator | Standard post-operative nursing and medical care provided in hospital clinic Receives: Other: Standard arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colo Rectal Functional Outcome Score (COREFO)
Between group comparison of outcome score - total and each of 5 domains
Measured: 6 and 12 months following ileostomy reversal
Secondary outcomes (8)
Pouch Dysfunction score
Comparison of scores between groups
Measured: 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
Measured: 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.
Measured: Baseline,3,6 and 12 months following ileostomy closure
Inflammatory Bowel Disease Questionnaire (IBDQ)
Disease specific quality of life score comparing groups
Measured: 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
Measured: Baseline,3,6 and 12 months following ileostomy closure
Brief Illness Perception Questionnaire
Between group comparison of cognitive and emotional perceptions of illness
Measured: Baseline,3,6 and 12 months following ileostomy closure
Brief Cope
Between group comparison of coping styles and ability to cope with stress
Measured: 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
Measured: Baseline,3,6 and 12 months following ileostomy closure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2017
- Study start20 Apr 2017
- Primary completion19 Nov 2025
- Study completion19 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic PouchesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- St Vincent's Hospital Melbourne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angela Khera, St Vincent's Hospital Melbourne
- Investigators
- Michael A Kamm, MBBS,PhD, Principal investigator, St Vincent's Hospital Melbourne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03148600
- Sponsor's protocol ID
- HREC/16/SVHM/214
- Acronym
- RAP
- Status last verified
- Mar 2026
- First submitted
- 20 Apr 2017
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioural Treatment Following Ileo-Anal Pouch Formation:
- ClinicalTrials.gov ID
- NCT03148600
- Acronym / sponsor ID
- RAP / HREC/16/SVHM/214
- Conditions
- Colonic Pouches, Physical Therapy Modalities, Biofeedback
- Keywords
- Ileoanal pouch, pelvic floor exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- St Vincent's Hospital MelbourneUniversity, hospital or other
- Study start
- 20 Apr 2017 (actual)
- Primary completion
- 19 Nov 2025 (actual)
- Study completion
- 19 Nov 2025 (actual)
- First posted
- 11 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Active comparator | Behavioral: Pelvic floor and bowel behavioural trainingPelvic 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 | Other: Standard armStandard post-operative nursing and medical care provided in hospital clinic |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pelvic floor and bowel behavioural trainingPhysiotherapist-led pelvic floor muscle and bowel behavioural training | Behavioural | Intervention arm |
| Standard armStandard medical and nursing care | Other | Standard arm |
Primary outcome
Colo Rectal Functional Outcome Score (COREFO)
Time frame: 6 and 12 months following ileostomy reversal
Between group comparison of outcome score - total and each of 5 domains
8 secondary outcomes
Pouch Dysfunction score
Time frame: 1,3,6 and 12 months following ileostomy closure
Quality of Life Short-Form 36 (SF-36)
Time frame: Baseline, 3,6 and 12 months following ileostomy closure
Quality of Life EQ-5D
Time frame: Baseline,3,6 and 12 months following ileostomy closure
Inflammatory Bowel Disease Questionnaire (IBDQ)
Time frame: Baseline,3,6 and 12 months following ileostomy closure
Hospital Anxiety and Depression Scale (HADs)
Time frame: Baseline,3,6 and 12 months following ileostomy closure
Brief Illness Perception Questionnaire
Time frame: Baseline,3,6 and 12 months following ileostomy closure
Brief Cope
Time frame: Baseline,3,6 and 12 months following ileostomy closure
New General Self-Efficacy Scale
Time frame: Baseline,3,6 and 12 months following ileostomy closure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Colonic Pouches
Recruiting
Evaluation of the Ileo-anal Pouch in FAP (ENDOPOL)
Familial Adenomatous Polyposis (FAP), Pouches, Ileoanal
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael A Kamm, MBBS,PhD principal investigator
St Vincent's Hospital Melbourne
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic floor and bowel behavioural training and Standard arm in people with Colonic Pouches and Physical Therapy Modalities, run by St Vincent's Hospital Melbourne at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Colo Rectal Functional Outcome Score (COREFO) (time frame: 6 and 12 months following ileostomy reversal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.