Rehabilitation After Ileo-anal Pouch Surgery

St Vincent's Hospital Melbourne53 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

Alfred Health

Prahran, Victoria, Australia

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

Data from ClinicalTrials.gov

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