The Trans Anal Irrigation Study. Investigation of the use of colonic irrigation in adults with spinal cord disorders.

Not Applicable

Withdrawn

• Conditions: spinal cord injury; spina bifida; neurogenic bowel dysfunction; Neurological - Other neurological disorders

• Registration Number: ACTRN12621000406808
• Lead Sponsor: niversity of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-04-14
• Last Update Posted: 24 April 2023

Recruitment & Eligibility

• Status: Withdrawn
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

People will be eligible for inclusion if they:
* sustained a spinal cord injury more than 6 months prior or have Spina Bifida
* have a Neurogenic Bowel Dysfunction Score greater than or equal to 3
* are aged 18 years or over at the time of consent
* are willing to participate in the trial
* have been recommended to trial transanal irrigation by a clinician because they spend more than 30 mins on toileting AND ANY OF THE FOLLOWING:
had more than 1 episode of faecal incontinence per month
had a Bristol stool chart result of less than 3 or greater than 6 for more than 3 cycles of bowel care
experienced abdominal symptoms such as bloating/cramping
experienced inconsistency with defaecation
experienced rectal symptoms (bleeding haemorrhoids, rectal prolapse, fissures etc)
experienced autonomic dysreflexia in response to bowel care

Exclusion Criteria

People will be excluded if:
* they are unable to co-operate (e.g. a serious medical condition, cognitive impairment, drug dependency, psychiatric illness, and behavioural problem)
* they are unable to speak sufficient English to provide informed consent
* they are currently using bisacodyl suppositories or enemas as the primary method for managing bowel care routine.
* transanal irrigation is contraindicated for use for any of the following reasons:
anal / rectal stenosis
active inflammatory bowel disease
acute diverticulitis
colorectal cancer
within 3 months of rectal surgery
within 4 weeks of endoscopic polypectomy
ischaemic colitis
* current or planned pregnancy
* long term steroid therapy
* radiotherapy to the pelvis
* dense sigmoid disease
* on anticoagulants (warfarin, apixaban, rivaroxaban, dabigatran)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to complete bowel care (assessor determined): The time from commencement of the enema/irrigation administration procedure to completion of faecal elimination as defined by an empty rectum on per rectum (pr) check. This will be assessed using the stopwatch function on the assessors phone.[This will be assessed 4 times: on two occasions (2 separate days) at baseline (after randomisation) and on two occasions at week 6 (upon completion of the trial). The two measurements taken at each time point will be averaged to attain one score for each time point.]