Clinical trial NCT03148600: Rehabilitation After Ileo-anal Pouch Surgery
Official title: Behavioural Treatment Following Ileo-Anal Pouch Formation:
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colonic Pouches
Physical Therapy Modalities
Biofeedback
Keywords: Ileoanal pouch, pelvic floor exercise
Lead sponsor: St Vincent's Hospital Melbourne
Sponsor class: OTHER
First posted: 2017-05-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Colo Rectal Functional Outcome Score (COREFO)
timeFrame: 6 and 12 months following ileostomy reversal
Secondary outcomes:
measure: Pouch Dysfunction score
timeFrame: 1,3,6 and 12 months following ileostomy closure
measure: Quality of Life Short-Form 36 (SF-36)
timeFrame: Baseline, 3,6 and 12 months following ileostomy closure
measure: Quality of Life EQ-5D
timeFrame: Baseline,3,6 and 12 months following ileostomy closure
measure: Inflammatory Bowel Disease Questionnaire (IBDQ)
timeFrame: Baseline,3,6 and 12 months following ileostomy closure
measure: Hospital Anxiety and Depression Scale (HADs)
timeFrame: Baseline,3,6 and 12 months following ileostomy closure
measure: Brief Illness Perception Questionnaire
timeFrame: Baseline,3,6 and 12 months following ileostomy closure
measure: Brief Cope
timeFrame: Baseline,3,6 and 12 months following ileostomy closure
measure: New General Self-Efficacy Scale
timeFrame: Baseline,3,6 and 12 months following ileostomy closure
Other outcomes:
measure: Patient Global Impression of Improvement and Satisfaction
timeFrame: 3,6 and 12 months following ileostomy closure
measure: Adherence
timeFrame: 1,2,3,4,5 and 6 months following ileostomy closure
measure: Pelvic floor muscle function
timeFrame: Baseline and 6 months following ileostomy closure
measure: Cost to the healthcare system
timeFrame: Baseline, 6 and 12 months following ileostomy closure
Locations:
city: Fitzroy
country: Australia
facility: St Vincent's Hospital
state: Victoria
city: Prahran
country: Australia
facility: Alfred Health
state: Victoria
Study officials:
affiliation: St Vincent's Hospital Melbourne
name: Michael A Kamm, MBBS,PhD
role: PRINCIPAL_INVESTIGATOR
References: