Rehabilitation After Ileo-anal Pouch Surgery

St Vincent's Hospital Melbourne60 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Colonic Pouches Physical Therapy Modalities Biofeedback

Interventions

Pelvic floor and bowel behavioural trainingBEHAVIORAL

Physiotherapist-led pelvic floor muscle and bowel behavioural training

Standard armOTHER

Standard medical and nursing care

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (2)

St Vincent's Hospital

Fitzroy, Victoria, Australia

RECRUITING

Alfred Health

Prahran, Victoria, Australia

NOT_YET_RECRUITING

Outcomes

Primary Outcomes

Colo Rectal Functional Outcome Score (COREFO)

Between group comparison of outcome score - total and each of 5 domains

Time frame: 6 and 12 months following ileostomy reversal

Secondary Outcomes

Pouch Dysfunction score

Comparison of scores between groups

Time frame: 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

Time frame: 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.

Time frame: Baseline,3,6 and 12 months following ileostomy closure

Inflammatory Bowel Disease Questionnaire (IBDQ)

Disease specific quality of life score comparing groups

Time frame: 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

Time frame: Baseline,3,6 and 12 months following ileostomy closure

Brief Illness Perception Questionnaire

Between group comparison of cognitive and emotional perceptions of illness

Time frame: Baseline,3,6 and 12 months following ileostomy closure

Central Contacts

Angela J Khera, BAppSc

CONTACT

+61 419 110 756 angela.khera@svhm.org.au

Amy Wilson-O'Brien, BSc,PhD

CONTACT

+61 3 9231 2316 amy.wilson-obrien@svhm.org.au

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.