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Trial registered on ANZCTR


Registration number
ACTRN12618000221257
Ethics application status
Approved
Date submitted
21/09/2017
Date registered
12/02/2018
Date last updated
9/11/2021
Date data sharing statement initially provided
4/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Does the type of enema administration affect time to complete bowel care in people with recent Spinal Cord Injury?
Scientific title
Is the time to complete bowel care as quick if not quicker using a low micro enema compared to a high micro enema in people with a recent spinal cord injury?: A non-inferiority, double blinded, cross over randomised control trial
Secondary ID [1] 291526 0
None
Universal Trial Number (UTN)
U1111-1194-6282
Trial acronym
The HELMeT study (The High Enema vs Low eneMa Trial)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
neurogenic bowel 302613 0
spinal cord injury 302614 0
Condition category
Condition code
Neurological 302137 302137 0 0
Other neurological disorders
Oral and Gastrointestinal 304488 304488 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Injuries and Accidents 304489 304489 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants are randomised into one of two treatment sequences.

Treatment sequence 1:
Participants will receive a low enema for 4 weeks then switch to high enema for 4 weeks.

Treatment sequence 2:
Participants will receive a high enema for 4 weeks then switch to low enema for 4 weeks.

Low enema:
5mL of micro enema (sodium citrate 450mg, sodium lauryl sulfoacetate 45mg and sorbitol 3.125g in 5mL) will be administered into the anal canal but not past the anorectal ring.

High enema:
5mL of micro enema (sodium citrate 450mg, sodium lauryl sulfoacetate 45mg and sorbitol 3.125g in 5mL) will be transferred into a 10ml syringe attached to a nelaton catheter cut to 10cm. The syringe will be primed to 5mL (the standard dose of the micro enema) which is then passed through the anorectal ring and administered into the rectum, but not past the inferior rectal valve (3rd valve of Housten).

This treatment will be administered by nursing and technical staff once per day.

All nursing and technical staff involved in the project will attend education on the correct procedure for enema administration and complete a competency prior to participating in the study. Compliance with this requirement will be recorded in the site specific investigator folder.

The majority of people with Spinal Cord Injury do not defecate without external stimulation / intervention, The consequences of not defecating are constipation, fecal incontinence, impaction and for some, Autonomic Dysreflexia. People with Spinal Cord Injury are highly motivated to avoid these negative outcomes are therefore adherence to treatment is expected to be high.

For these reasons, there cannot be a 'wash out' period in the traditional sense. Expert clinical advice determines that any change in bowel care routines require 2 weeks to establish, which is why the design of the study takes this into account. i.e. 2 weeks of the 'changed intervention' to re-establish routine and 2 weeks of the routine prior to measuring outcomes.
Intervention code [1] 297596 0
Treatment: Drugs
Intervention code [2] 299426 0
Treatment: Devices
Comparator / control treatment
The control will be the standard 'low' enema
Control group
Active

Outcomes
Primary outcome [1] 301568 0
Time to complete bowel care (assessor determined):
The time from commencement of the enema administration procedure to completion of faecal elimination as defined by an empty rectum on per rectum (pr) check.
Timepoint [1] 301568 0
This will be assessed 6 times: three times in week 4 post randomisation (end of phase 1) and three times in week 8 post randomisation (end of phase 2). Measurements will be averaged to attain one time for each of the two 4-week phases.
Secondary outcome [1] 333051 0
Time to complete bowel care (participant determined):
The time from commencement of the enema administration procedure to completion of faecal elimination as defined by an empty rectum on per rectum (pr) check. The patients will be required to use a stop watch /timer to time bowel care and enter the bowel care times into a diary.
Timepoint [1] 333051 0
Participants will be required to do this 12 times: six times in weeks 3 and 4 post randomisation (end of phase 1), and six times in weeks 7 and 8 post randomisation (end of phase 2). Measurements will be averaged to attain one time for each of the two 4-week phases.
Secondary outcome [2] 333075 0
Frequency of unplanned bowel evacuations:
This outcome captures faecal incontinence outside of regular bowel care. It will be measured using the Douglas Wong Score. This is a 5-item self-report questionnaire.
Timepoint [2] 333075 0
This will be administered 6 times: three times in week 4 post randomisation (end of phase 1), and three times in week 8 post randomisation (end of phase 2). Measurements will be averaged to attain one score for each of the two 4-week phases.
Secondary outcome [3] 333076 0
Perception of effectiveness of bowel care routine (Participant reported):
This outcome captures participants’ perception of the effectiveness of their bowel routines over the last 4 weeks. It will be measured using a 11-point Likert Scale (0-10), anchored at each end from “extremely ineffective” to “extremely effective”.
Participants will be asked:
How effective do you think your bowel routine has been over the last 4 weeks? Please rate on the below scale from 0 to 10 where 0 indicates "extremely ineffective" and 10 indicates "extremely effective".
Timepoint [3] 333076 0
This will be administered 6 times: three times in week 4 post randomisation (end of phase 1), and three times in week 8 post randomisation (end of phase 2). Measurements will be averaged to attain one score for each of the two 4-week phases.
Secondary outcome [4] 333077 0
Perception of effectiveness of bowel care routine (Nurse reported):
This outcome captures nurses’ perception of the effectiveness of their bowel routines over the last 4 weeks. It will be measured using a 11-point Likert Scale (0-10), anchored at each end from “extremely ineffective” to “extremely effective”.
The nurse will be asked:
How effective do you think your patients’ bowel routine has been over the last 4 weeks? Please rate on the below scale from 0 to 10 where 0 indicates "extremely ineffective" and 10 indicates "extremely effective".
Timepoint [4] 333077 0
This will be administered 6 times: three times in week 4 post randomisation (end of phase 1), and three times in week 8 post randomisation (end of phase 2). Measurements will be averaged to attain one score for each of the two 4-week phases.
Secondary outcome [5] 333078 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.
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 [5] 333078 0
This will be administered 6 times: three times in week 4 post randomisation (end of phase 1), and three times in week 8 post randomisation (end of phase 2). Measurements will be averaged to attain one score for each of the two 4-week phases.

Eligibility
Key inclusion criteria
* have a complete or incomplete SCI sustained within the past six months (as defined by the International Standards for Neurological classification of SCI)
* have return of gastrointestinal tract function (ie., adequate oral intake, bowel sounds, passing flatus / stool) and are in a stable bowel care routine
* have intact anorectal reflexes as confirmed by per rectal (pr) examination
* are an inpatient at one of the participating SCI units and likely to remain there for the duration of his/her involvement in the trial (i.e., approximately 8 weeks)
* aged 16 years or over at the time of consent
* willing to participate in the trial
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* unable to co-operate (e.g. a serious medical condition, cognitive impairment, drug dependency, psychiatric illness, or behavioural problem)
* unable to speak sufficient English to fully understand and perform required activities and complete assessments
* unable to tolerate an enema for medical reasons (i.e, contraindicated)
* have any other type of neurological condition or injury other than spinal cord injury affecting bowel function
* have an allergy to any of the ingredients used in Microlax ®
* have complications related to bowel care (eg. Autonomic Dysreflexia, haemodynamic instability)

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.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation schedule will be stratified by site. A separate randomisation sequence will be created for each site using varying sized permuted blocks. The sequence of block sizes will be randomised as will the allocations within each block. This will ensure equal (or near equal) numbers of participants will be randomised to each sequence of treatments across all sites. A participant will be entered into the trial when baseline details are logged and the allocation is provided.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The non-inferiority margin will be set at 10 minutes. This is based on clinical judgement and after taking into account the time bowel care typically takes (ie. 41 minutes). Therefore, a sample of 90 participants is required for a 90 percent power to show non-inferiority of the low enema at a one-sided alpha level of 0.05 and with a worst-case dropout rate of 15 percent. This assumes a SD of 18 minutes (before adjustment for the within-subject design). The estimated SD was derived from data collected on 23 inpatients at Royal North Shore Hospital in Feb 2017 (non-published data) and from our own cross-over trial.

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).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2018
Actual
28/01/2019
Date of last participant enrolment
Anticipated
30/06/2021
Actual
11/05/2021
Date of last data collection
Anticipated
30/09/2021
Actual
8/07/2021
Sample size
Target
20
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 7729 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [2] 7923 0
Royal Rehabilitation Hospital - Coorabel/Moorong - Ryde
Recruitment postcode(s) [1] 15653 0
2065 - St Leonards
Recruitment postcode(s) [2] 15885 0
2112 - Ryde

Funding & Sponsors
Funding source category [1] 296014 0
Hospital
Name [1] 296014 0
Royal North Shore Hospital
Country [1] 296014 0
Australia
Funding source category [2] 297808 0
Commercial sector/Industry
Name [2] 297808 0
Slater and Gordon Health Care Projects & Research Funds
Country [2] 297808 0
Australia
Funding source category [3] 298032 0
Government body
Name [3] 298032 0
icare
Country [3] 298032 0
Australia
Primary sponsor type
Government body
Name
Northern Sydney Local Health District
Address
Building 51
RNSH Campus
Reserve Rd,
St Leonards,
2065 NSW
Country
Australia
Secondary sponsor category [1] 294908 0
University
Name [1] 294908 0
University of Sydney
Address [1] 294908 0
Level 13
Kolling Building
RNSH Campus
Reserve Rd,
St Leonards,
2065 NSW
Country [1] 294908 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297275 0
Northern Sydney Local Health District
Ethics committee address [1] 297275 0
Ethics committee country [1] 297275 0
Australia
Date submitted for ethics approval [1] 297275 0
24/04/2017
Approval date [1] 297275 0
14/06/2017
Ethics approval number [1] 297275 0
HREC/17/HAWKE/146

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 73550 0
Ms Louise Kelly
Address 73550 0
Level 7E
Acute Services Building,
Royal North Shore Hospital
Reserve Rd
St Leonards
2065 NSW
Country 73550 0
Australia
Phone 73550 0
+61 2 9463 2756
Fax 73550 0
+61 2 9463 2019
Email 73550 0
lgal2519@uni.sydney.edu.au
Contact person for public queries
Name 73551 0
Louise Kelly
Address 73551 0
Level 7E
Acute Services Building,
Royal North Shore Hospital
Reserve Rd
St Leonards,
2065 NSW
Country 73551 0
Australia
Phone 73551 0
+61 2 9463 2756
Fax 73551 0
+61 2 9463 2019
Email 73551 0
lgal2519@uni.sydney.edu.au
Contact person for scientific queries
Name 73552 0
Lisa Harvey
Address 73552 0
Level 13
Kolling Building
RNSH Campus
Reserve Rd
St Leonards
2065 NSW
Country 73552 0
Australia
Phone 73552 0
+61 2 9926 4594
Fax 73552 0
+61 2 9926 4045
Email 73552 0
lisa.harvey@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All individual participant data collected during the trial, after deidentifiation
When will data be available (start and end dates)?
Immediately following publication. No end date
Available to whom?
anyone who wishs to access the data
Available for what types of analyses?
Any purpose
How or where can data be obtained?
data to be obtained indefinitely at (link to be includedd)


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10726Study protocol  lgal2519@uni.sydney.edu.au



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseAre micro enemas administered with a squeeze tube and a 5 cm-long nozzle as good or better than micro enemas administered with a 10 cm-long catheter attached to a syringe in people with a recent spinal cord injury? A non-inferiority, crossover randomised controlled trial.2022https://dx.doi.org/10.1038/s41393-022-00835-5
N.B. These documents automatically identified may not have been verified by the study sponsor.