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Completed

NCT Number: NCT03148600

Rehabilitation After Ileo-anal Pouch Surgery

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.

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Key information

Conditions

Colonic Pouches Biofeedback Physical Therapy Modalities

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St Vincent's Hospital, Fitzroy, Victoria, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pelvic floor and bowel behavioural training

Behavioral

Physiotherapist-led pelvic floor muscle and bowel behavioural training

Standard Arm

Other

Standard medical and nursing care

Primary outcomes

  1. Colo Rectal Functional Outcome Score (COREFO)

    Time frame: 6 and 12 months following ileostomy reversal

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

Secondary outcomes

  1. Pouch Dysfunction score

    Time frame: 1,3,6 and 12 months following ileostomy closure

    Comparison of scores between groups

  2. Quality of Life Short-Form 36 (SF-36)

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

    Quality of life SF-36 compared between groups - mental health domain, physical health domain and total score

  3. Quality of Life EQ-5D

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

    Scores from the EQ-5D will be compared between groups and quality adjusted life years (QALY) will be derived from EQ-5D.

  4. Inflammatory Bowel Disease Questionnaire (IBDQ)

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

    Disease specific quality of life score comparing groups

  5. Hospital Anxiety and Depression Scale (HADs)

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

    Psychological well being scores for anxiety and depression comparing groups

  6. Brief Illness Perception Questionnaire

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

    Between group comparison of cognitive and emotional perceptions of illness

  7. Brief Cope

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

    Between group comparison of coping styles and ability to cope with stress

  8. New General Self-Efficacy Scale

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

    Between group comparison of confidence in ability to perform tasks and achieve goals

Other outcomes

  1. Patient Global Impression of Improvement and Satisfaction

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

    Between group comparison of patient rating of improvement and satisfaction on 7-point Likert Scales

  2. Adherence

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

    Patient rating of their level of adherence to the training programme

  3. Pelvic floor muscle function

    Time frame: Baseline and 6 months following ileostomy closure

    Transperineal measurements of displacement of puborectalis and change in anorectal angle with pelvic floor muscle contraction and with simulated defaecation

  4. Cost to the healthcare system

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

    Compare health care utilisation between groups

Sponsors and collaborators

Lead sponsor

St Vincent's Hospital Melbourne

Other

Registry information

Official study title

Behavioural Treatment Following Ileo-Anal Pouch Formation:

Acronym: RAP

Important dates

Study start
2017
Primary completion
2025
Study completion
2025
First posted
May 11, 2017
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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