Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000406808
Ethics application status
Approved
Date submitted
18/02/2021
Date registered
14/04/2021
Date last updated
19/04/2023
Date data sharing statement initially provided
14/04/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The Trans Anal Irrigation Study. Investigation of the use of colonic irrigation in adults with spinal cord disorders.
Scientific title
Is the time to complete bowel care quicker using transanal irrigation compared to standard bowel care in adults with Spinal Cord Disorders? A randomised controlled trial.
Secondary ID [1] 303475 0
Nil known
Universal Trial Number (UTN)
U1111-1259-9022
Trial acronym
the TAI Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
spinal cord injury 321153 0
spina bifida 321154 0
neurogenic bowel dysfunction 321155 0
Condition category
Condition code
Neurological 318610 318610 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The participant will use transanal irrigation daily or second daily (depending upon his/her current bowel routine) for a period of 6 weeks. Bowel care will occur at the usual time that the participant normally attends to his/her toileting. The irrigation system includes a reservoir for water, tubing, a rectal catheter and operating controls that inflate/ deflate the rectal catheter balloon and start/stop the flow of water. The process includes filling the water reservoir with lukewarm/tepid water, sitting the participant on a commode chair over the toilet, inserting the rectal catheter into the anus, inflating the balloon, and using a switch to start the flow of water and using the hand pump periodically to instill approx 400mL into the colon before deflating the balloon and waiting for bowel result. It is anticipated that this process will not take any longer than 30 minutes. Partipants will record bowel care interventions on a bowel chart which will be checked by a study nurse via weekly phone follow up.
Intervention code [1] 319765 0
Treatment: Devices
Comparator / control treatment
The participant will continue to use rectal medication / procedures as usual for a period of six weeks. Bowel care will be provided by the participant or carers. Bowel care will occur at the usual time that s/he attends to his/her toileting and all participants will have bowel care whilst seated on a commode chair over their toilet. This process includes transferring onto a commode chair, being placed over a toilet, insertion of a micro enema or suppository into the anus, wait for a response using intermittement digital stimulation or digital evacuation of stool.

Regardless of which trial arm participants are allocated to, they will continue to receive all other non-rectal aspects of a ‘bowel routine’ that constitutes ‘standard care’. This includes dietary and fluid management, the use of timed toileting (eliminating at the same time each day), pr checks prior to commencing and at the end of bowel care and the use of aperients titrated by stool consistency documented using the Bristol stool chart.
Control group
Active

Outcomes
Primary outcome [1] 326571 0
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.
Timepoint [1] 326571 0
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.
Secondary outcome [1] 391934 0
Time to complete bowel care (participant 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.
Timepoint [1] 391934 0
The participants will be required to use a stopwatch /timer to time bowel care on two occasions (2 separate days) at baseline (after randomisation) and on two occasions (2 separate days) at week 6 (upon completion of the trial).
Secondary outcome [2] 391939 0
Severity of constipation: This outcome captures the severity of constipation. It will be measured using the Cleveland Clinic Constipation Scoring System (CCCSS). This is an 8–item self-report questionnaire. Participants are required to respond to questions such as “completeness: Feeling incomplete evacuation: on a Likert scale (0-4) anchored with the following words “never”, rarely”, “sometimes”, “usually”, “always”. Total scores range from 0-30 (30 being the most severe symptoms of constipation).
Timepoint [2] 391939 0
This will be assessed 4 times: twice prior to commencing the trial (baseline) and twice in week 6 (upon completion of the trial). Measurements will be averaged to attain one score for each endpoint.
Secondary outcome [3] 391940 0
Frequency of unplanned bowel evacuations: This outcome captures faecal incontinence outside of regular bowel care. It will be measured using the Vaizey (St Mark’s) Faecal Incontinence Scale. This is a 7-item self-report questionnaire with an overall score ranging from 0-24 (0 = perfect continence, 24 being totally incontinent). Participants will be required to respond to questions such as “in the past 4 weeks I had incontinence of solid stool” on a Likert scale (0-4) anchored with the following words “never”, “rarely”, “sometimes”, “weekly”, “daily”.
Timepoint [3] 391940 0
This will be assessed 4 times: twice prior to commencing the trial (baseline) and twice in week 6 (upon completion of the trial). Measurements will be averaged to attain one score for each endpoint.
Secondary outcome [4] 391941 0
Spinal Cord Injury Quality of Life (SCI QoL) – Bowel Management Difficulties: This outcome captures quality of life due to bowel management difficulties. It will be measured using the SCI QoL. This is a 9-item self-report questionnaire with an overall raw score ranging from 9 to 45. Participants are required to respond to statements such as “I was frustrated by repeated bowel accidents” on a Likert Scale (1-5) anchored with the following words: “not at all”, “a little bit”, “somewhat”, quite a bit” and “very much”.
Timepoint [4] 391941 0
This will be assessed 4 times: twice prior to commencing the trial (baseline) and twice in week 6 (upon completion of the trial). The total raw score will be converted into a T score. Measurements will be averaged to attain one score for each endpoint.
Secondary outcome [5] 391942 0
Global impression of change in bowel function (Participant reported): This outcome captures participants’ perception of how much their bowel function has changed over the last six weeks. It will be measured using a 15-point Scale. Scores will be anchored at each end from -7 “very much worse” 0 “no change” to 7 “very much better”. Participants will be asked: Do you think there has been a change for better or worse in any aspects of your bowel function or bowel routine over the past 6 weeks? Please rate from -7 to 7 where -7 indicates "very much worse " 0 indicates “no change” and 7 indicates " very much better".
Timepoint [5] 391942 0
This will be assessed twice in week 6 (upon completion of the trial). Measurements will be averaged to attain one score for this endpoint.
Secondary outcome [6] 391943 0
Burden of treatment questionnaire. This outcome is designed to measure the level of burden participants feel around the treatment for their neurogenic bowel dysfunction over the past 6 weeks. It will be measured using an 11-point Likert Scale (0-10) anchored at each end from “not at all bothersome” to “extremely bothersome”. Participants will be asked: How bothersome have you found managing your bowel routine over the last 6 weeks? Please rate on the below scale from 0 to 10 where 0 indicates “not at all bothersome: and 10 indicates “extremely bothersome”.
Timepoint [6] 391943 0
This will be assessed on two occasions at week 6 (upon completion of the trial). Measurements will be averaged to attain one score for each endpoint.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A secure random-allocation schedule will be computer-generated prior to commencement of the trial by an independent person and kept at a central off-site location. The randomisation schedule will be blocked (1:1) to ensure equal numbers of participants are randomised to the treatment and control arms.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All statistical analyses will be done using the principles of ‘intention to treat’. Regression models will be used to determine between group differences (and 95% CI). Results will be interpreted with respect to the pre-defined treatment effect of 20 minutes. The ‘centile’ routine in Stata (v9.2; Statacorp, TX, USA) may also be used to derive the 95% CIs for median between group differences for data which is not normally distributed. This method does not make assumptions about the distribution of the data.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
31/03/2022
Actual
Date of last participant enrolment
Anticipated
31/03/2024
Actual
Date of last data collection
Anticipated
12/05/2024
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 18734 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 33178 0
2065 - St Leonards

Funding & Sponsors
Funding source category [1] 307003 0
Government body
Name [1] 307003 0
Lifetime Care and Support Authority of New South Wales
Country [1] 307003 0
Australia
Primary sponsor type
University
Name
University of Sydney
Country
Australia
Secondary sponsor category [1] 308609 0
Hospital
Name [1] 308609 0
Royal North Shore Hospital
Country [1] 308609 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307135 0
Northern Sydney Local Health District
Ethics committee address [1] 307135 0
Ethics committee country [1] 307135 0
Australia
Date submitted for ethics approval [1] 307135 0
27/01/2021
Approval date [1] 307135 0
12/03/2021
Ethics approval number [1] 307135 0
2020/ETH02994

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 106154 0
Prof Lisa Harvey
Address 106154 0
Level 12 John Walsh Centre for Rehabilitation Studies Kolling Building Reserve Rd St Leonards, NSW 2065
Country 106154 0
Australia
Phone 106154 0
+61 2 9926 4594
Fax 106154 0
Email 106154 0
l.harvey@usyd.edu.au
Contact person for public queries
Name 106155 0
Louise Kelly
Address 106155 0
Level 12 John Walsh Centre for Rehabilitation Studies Kolling Building Reserve Rd St Leonards, NSW 2065
Country 106155 0
Australia
Phone 106155 0
+61 2 9926 4594
Fax 106155 0
Email 106155 0
lgal2519@uni.sydney.edu.au
Contact person for scientific queries
Name 106156 0
Lisa Harvey
Address 106156 0
Level 12 John Walsh Centre for Rehabilitation Studies Kolling Building Reserve Rd St Leonards, NSW 2065
Country 106156 0
Australia
Phone 106156 0
+61 2 9926 4594
Fax 106156 0
Email 106156 0
l.harvey@usyd.edu.au

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• anyone who wishs to access the data

Conditions for requesting access:
• -

What individual participant data might be shared?
• All individual participant data collected during the trial, after de-identifiation

What types of analyses could be done with individual participant data?
• Any purpose

When can requests for individual participant data be made (start and end dates)?
From:
Immediately following publication. No end date.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Data will be provided as a supplementary file as part of the journal's online publication of the article.

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10745Study protocol    Study-related document.pdf
11054Informed consent form    Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.