Rehabilitation After Ileo-anal Pouch Surgery

NCT ID: NCT03148600

Last Updated: 2025-05-15

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-20

Study Completion Date

2025-12-31

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.

Detailed Description

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Conditions

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Colonic Pouches Physical Therapy Modalities Biofeedback

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

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

Group Type ACTIVE_COMPARATOR

Pelvic floor and bowel behavioural training

Intervention Type BEHAVIORAL

Physiotherapist-led pelvic floor muscle and bowel behavioural training

Standard arm

Standard post-operative nursing and medical care provided in hospital clinic

Group Type PLACEBO_COMPARATOR

Standard arm

Intervention Type OTHER

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

Intervention Type BEHAVIORAL

Standard arm

Standard medical and nursing care

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St Vincent's Hospital Melbourne

OTHER

Sponsor Role lead

Responsible Party

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Angela Khera

Senior Clinician Physiotherapist

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Alfred Health

Prahran, Victoria, Australia

Site Status NOT_YET_RECRUITING

Countries

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Australia

Central Contacts

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Angela J Khera, BAppSc

Role: CONTACT

+61 419 110 756

Amy Wilson-O'Brien, BSc,PhD

Role: CONTACT

+61 3 9231 2316

Facility Contacts

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Angela J Khera, BAppSc

Role: primary

+61 419 110 756

Amy Wilson-O'Brien, BSc, PhD

Role: backup

+ 61 3 9231 2316

Angela J Khera, BAppSc

Role: primary

+ 61 419110756

Amy Wilson-OBrien, BSc, PhD

Role: backup

+ 61 3 9231 2316

Other Identifiers

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HREC/16/SVHM/214

Identifier Type: -

Identifier Source: org_study_id

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