Rehabilitation After Ileo-anal Pouch Surgery

NCT03148600 | Completed DMC

• 1 other identifier: HREC/16/SVHM/214
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 2

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.

Conditions

Physical Therapy Modalities; Colonic Pouches; Biofeedback

Keywords

Ileoanal pouch, pelvic floor exercise

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Pouch Dysfunction score

  1,3,6 and 12 months following ileostomy closure

• Quality of Life Short-Form 36 (SF-36)

  Baseline, 3,6 and 12 months following ileostomy closure

• Quality of Life EQ-5D

  Baseline,3,6 and 12 months following ileostomy closure

• Inflammatory Bowel Disease Questionnaire (IBDQ)

  Baseline,3,6 and 12 months following ileostomy closure

• Hospital Anxiety and Depression Scale (HADs)

  Baseline,3,6 and 12 months following ileostomy closure

Other Outcomes (4)

• Patient Global Impression of Improvement and Satisfaction

  3,6 and 12 months following ileostomy closure

• Adherence

  1,2,3,4,5 and 6 months following ileostomy closure

• Pelvic floor muscle function

  Baseline and 6 months following ileostomy closure

Study Arms (2)

Intervention arm

ACTIVE COMPARATOR

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

Standard arm

PLACEBO COMPARATOR

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

Other: Standard arm

Interventions

Standard arm OTHER

Standard medical and nursing care

Standard arm

Pelvic floor and bowel behavioural training BEHAVIORAL

Physiotherapist-led pelvic floor muscle and bowel behavioural training

Intervention arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St Vincent's Hospital Melbourne: lead

Study Sites (2)

St Vincent's Hospital

Fitzroy, Victoria, 3065, Australia

Location

Alfred Health

Prahran, Victoria, 3181, Australia

Location

Study Officials

• Michael A Kamm, MBBS,PhD

  St Vincent's Hospital Melbourne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Clinician Physiotherapist

Study Record Dates

• First Submitted: April 20, 2017
• First Posted: May 11, 2017
• Study Start: April 20, 2017
• Primary Completion: November 19, 2025
• Study Completion: November 19, 2025
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)