Rehabilitation After Ileo-anal Pouch Surgery

Physical Therapy Modalities Clinical Trial

— RAP  

Official title:

Behavioural Treatment Following Ileo-Anal Pouch Formation:

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03148600
• Other study ID #: HREC/16/SVHM/214
• Status: Recruiting
• Phase: N/A
• Start date: April 20, 2017
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: St Vincent's Hospital Melbourne
• Contact: Angela J Khera, BAppSc
• Phone: +61 419 110 756
• Email: angela.khera[@]svhm.org.au
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Biofeedback
• Colonic Pouches
• Physical Therapy Modalities

Intervention

Behavioral:
• Pelvic floor and bowel behavioural training
Physiotherapist-led pelvic floor muscle and bowel behavioural training

Other:
• Standard arm
Standard medical and nursing care

Locations

Country	Name	City	State
Australia	St Vincent's Hospital	Fitzroy	Victoria
Australia	Alfred Health	Prahran	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
St Vincent's Hospital Melbourne

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Adherence	Patient rating of their level of adherence to the training programme	1,2,3,4,5 and 6 months following ileostomy closure
Other	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
Other	Cost to the healthcare system	Compare health care utilisation between groups	Baseline, 6 and 12 months following ileostomy closure
Primary	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	Pouch Dysfunction score	Comparison of scores between groups	1,3,6 and 12 months following ileostomy closure
Secondary	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
Secondary	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
Secondary	Inflammatory Bowel Disease Questionnaire (IBDQ)	Disease specific quality of life score comparing groups	Baseline,3,6 and 12 months following ileostomy closure
Secondary	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
Secondary	Brief Illness Perception Questionnaire	Between group comparison of cognitive and emotional perceptions of illness	Baseline,3,6 and 12 months following ileostomy closure
Secondary	Brief Cope	Between group comparison of coping styles and ability to cope with stress	Baseline,3,6 and 12 months following ileostomy closure
Secondary	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