Rehabilitation After Ileo-anal Pouch Surgery (RAP)

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.

Study Overview

• Status: Recruiting
• Conditions: Physical Therapy Modalities; Biofeedback; Colonic Pouches
• Intervention / Treatment: Behavioral: Pelvic floor and bowel behavioural training; Other: Standard arm

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Fitzroy, Victoria, Australia, 3065
      • Recruiting
      • St Vincent's Hospital
    • Prahran, Victoria, Australia, 3181
      • Not yet recruiting
      • Alfred Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Behavioral: Pelvic floor and bowel behavioural training; Physiotherapist-led pelvic floor muscle and bowel behavioural training
Placebo Comparator: Standard arm; Standard post-operative nursing and medical care provided in hospital clinic	Other: Standard arm; Standard medical and nursing care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Colo Rectal Functional Outcome Score (COREFO)	Between group comparison of outcome score - total and each of 5 domains	6 and 12 months following ileostomy reversal

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pouch Dysfunction score	Comparison of scores between groups	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	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.	Baseline,3,6 and 12 months following ileostomy closure
Inflammatory Bowel Disease Questionnaire (IBDQ)	Disease specific quality of life score comparing groups	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	Baseline,3,6 and 12 months following ileostomy closure
Brief Illness Perception Questionnaire	Between group comparison of cognitive and emotional perceptions of illness	Baseline,3,6 and 12 months following ileostomy closure
Brief Cope	Between group comparison of coping styles and ability to cope with stress	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	Baseline,3,6 and 12 months following ileostomy closure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Global Impression of Improvement and Satisfaction	Between group comparison of patient rating of improvement and satisfaction on 7-point Likert Scales	3,6 and 12 months following ileostomy closure
Adherence	Patient rating of their level of adherence to the training programme	1,2,3,4,5 and 6 months following ileostomy closure
Pelvic floor muscle function	Transperineal measurements of displacement of puborectalis and change in anorectal angle with pelvic floor muscle contraction and with simulated defaecation	Baseline and 6 months following ileostomy closure
Cost to the healthcare system	Compare health care utilisation between groups	Baseline, 6 and 12 months following ileostomy closure

Collaborators and Investigators

• Sponsor: St Vincent's Hospital Melbourne

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2017
• Primary Completion (Anticipated): June 30, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: April 20, 2017
• First Submitted That Met QC Criteria: May 8, 2017
• First Posted (Actual): May 11, 2017

Study Record Updates

• Last Update Posted (Actual): April 12, 2023
• Last Update Submitted That Met QC Criteria: April 11, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Ileoanal pouch, pelvic floor exercise
• Other Study ID Numbers: HREC/16/SVHM/214

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No