Rehabilitation after surgery for ileo-anal pouch patients
Behavioural Treatment Following Ileo-Anal Pouch Formation:
This study tests if a special exercise program led by a physiotherapist can help people who have had ileo-anal pouch surgery recover better than those who just get standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | St Vincent's Hospital Melbourne Academic / other |
| Locations | 2 sites (Fitzroy, Victoria and 1 other locations) |
| Trial ID | NCT03148600 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a multi-centre, assessor-blinded, randomized controlled trial that compares a physiotherapist-led behavioral intervention, which includes pelvic floor muscle training, to standard care for patients who have undergone ileo-anal pouch surgery. The aim is to assess the effectiveness of this intervention in improving post-operative outcomes for patients with a history of Ulcerative Colitis or Familial Adenomatous Polyposis. Participants will be monitored for their bowel function and adherence to the training protocols over the course of the study.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with a documented history of Ulcerative Colitis or Familial Adenomatous Polyposis who have undergone proctocolectomy and are either awaiting ileo-anal pouch formation or have recently had stoma reversal.
Not a fit: Patients with significant medical or psychiatric comorbidities, substance abuse issues, or those currently participating in another trial may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved recovery and quality of life for patients after ileo-anal pouch surgery.
How similar studies have performed: Other studies have shown success with similar behavioral interventions in improving post-operative outcomes, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Fitzroy, Victoria and 1 other locations
- St Vincent's Hospital — Fitzroy, Victoria, Australia (Recruiting)
- Alfred Health — Prahran, Victoria, Australia (Not_yet_recruiting)
Study contacts
- Principal investigator: Michael A Kamm, MBBS,PhD — St Vincent's Hospital Melbourne
- Study coordinator: Angela J Khera, BAppSc
- Email: angela.khera@svhm.org.au
- Phone: +61 419 110 756
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.