Rehabilitation After Ileo-anal Pouch Surgery (RAP)

St Vincent's Hospital Melbourne

Status: Enrolling

Conditions: Colonic Pouches; Biofeedback; Physical Therapy Modalities

Treatments: Behavioral: Pelvic floor and bowel behavioural training; Other: Standard arm

Study type: Interventional

Funder types: Other

Identifiers

NCT03148600

HREC/16/SVHM/214

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

60 participants in 2 patient groups, including a placebo group

Intervention arm

Active Comparator group

Description:

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

Treatment:

Behavioral: Pelvic floor and bowel behavioural training

Standard arm

Placebo Comparator group

Description:

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

Treatment:

Other: Standard arm