Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03148600




Registration number
NCT03148600
Ethics application status
Date submitted
20/04/2017
Date registered
11/05/2017
Date last updated
9/05/2024

Titles & IDs
Public title
Rehabilitation After Ileo-anal Pouch Surgery
Scientific title
Behavioural Treatment Following Ileo-Anal Pouch Formation:
Secondary ID [1] 0 0
HREC/16/SVHM/214
Universal Trial Number (UTN)
Trial acronym
RAP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colonic Pouches 0 0
Physical Therapy Modalities 0 0
Biofeedback 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Behaviour - Pelvic floor and bowel behavioural training
Other interventions - Standard arm

Active Comparator: 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

Placebo Comparator: Standard arm - Standard post-operative nursing and medical care provided in hospital clinic


Behaviour: Pelvic floor and bowel behavioural training
Physiotherapist-led pelvic floor muscle and bowel behavioural training

Other interventions: Standard arm
Standard medical and nursing care
Intervention code [1] 0 0
Behaviour
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Colo Rectal Functional Outcome Score (COREFO)
Timepoint [1] 0 0
6 and 12 months following ileostomy reversal
Secondary outcome [1] 0 0
Pouch Dysfunction score
Timepoint [1] 0 0
1,3,6 and 12 months following ileostomy closure
Secondary outcome [2] 0 0
Quality of Life Short-Form 36 (SF-36)
Timepoint [2] 0 0
Baseline, 3,6 and 12 months following ileostomy closure
Secondary outcome [3] 0 0
Quality of Life EQ-5D
Timepoint [3] 0 0
Baseline,3,6 and 12 months following ileostomy closure
Secondary outcome [4] 0 0
Inflammatory Bowel Disease Questionnaire (IBDQ)
Timepoint [4] 0 0
Baseline,3,6 and 12 months following ileostomy closure
Secondary outcome [5] 0 0
Hospital Anxiety and Depression Scale (HADs)
Timepoint [5] 0 0
Baseline,3,6 and 12 months following ileostomy closure
Secondary outcome [6] 0 0
Brief Illness Perception Questionnaire
Timepoint [6] 0 0
Baseline,3,6 and 12 months following ileostomy closure
Secondary outcome [7] 0 0
Brief Cope
Timepoint [7] 0 0
Baseline,3,6 and 12 months following ileostomy closure
Secondary outcome [8] 0 0
New General Self-Efficacy Scale
Timepoint [8] 0 0
Baseline,3,6 and 12 months following ileostomy closure

Eligibility
Key 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
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/04/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
St Vincent's Hospital - Fitzroy
Recruitment hospital [2] 0 0
Alfred Health - Prahran
Recruitment postcode(s) [1] 0 0
3065 - Fitzroy
Recruitment postcode(s) [2] 0 0
3181 - Prahran

Funding & Sponsors
Primary sponsor type
Other
Name
St Vincent's Hospital Melbourne
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03148600
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael A Kamm, MBBS,PhD
Address 0 0
St Vincent's Hospital Melbourne
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Angela J Khera, BAppSc
Address 0 0
Country 0 0
Phone 0 0
+61 419 110 756
Fax 0 0
Email 0 0
angela.khera@svhm.org.au
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03148600