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Trial registered on ANZCTR


Registration number
ACTRN12620000131954
Ethics application status
Approved
Date submitted
17/12/2019
Date registered
11/02/2020
Date last updated
27/07/2020
Date data sharing statement initially provided
11/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Tranabdominal Electric Stimulation in the treatment of Chronic Constipation in Children - TESCCO trial
Scientific title
Double blind randomised, placebo-controlled clinical trial of transcutaneous electric stimulation in the treatment of chronic constipation in children
Secondary ID [1] 299789 0
None
Universal Trial Number (UTN)
U1111-1243-4223
Trial acronym
TESCCO
Linked study record
N.A

Health condition
Health condition(s) or problem(s) studied:
Chronic constipation
 315191 0
Encopresis 315192 0
Slow Colonic Transit 315193 0
Condition category
Condition code
Oral and Gastrointestinal 313507 313507 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Parents of Children in the treatment arm will be trained to use the transcutaneous electrical stimulator at home by clinical staff at point of recruitment at Waikato Hospital clinics.

To deliver current, 4 pads will be applied crossed diagonally from front to back. Interferential treatments delivered a 4- kHz carrier frequency, a beat frequency of 80 to 160 Hz with an intensity of less than 33 mA.

Participants in both arms will be instructed to deliver current, 1 hour daily over a period of 6 weeks. Adherence to intervention will be monitored by means of participant diaries where parents will report frequency of device usage and any issues encountered.
Intervention code [1] 316074 0
Treatment: Devices
Comparator / control treatment
The control arm will be given identical devices modified by the manufacturer to deliver a similar 4-kHz carrier frequency with a beat frequency of 80 to 160 Hz with an intensity of less than 33 mA. This is identical to the treatment arm.

After the first minute of application, devices provided to the control arm will be modified to gradually ramp down and stop all current delivered over a period of 5 minutes. The buzzing sensation typically experienced with cutaneous electric stimulation is felt typically around 5 minutes before the mind gets accustomed to and ignore the sensation.

Hence, our control design allows us to effectively blind participants in the control arm as the sensation they feel would be identical to those in the treatment arm.
Control group
Placebo

Outcomes
Primary outcome [1] 321965 0
Primary outcome assessed is the mean number of spontaneous bowel motions per week between treatment and control groups.
This will be measured with bowel diaries which will capture information on each bowel motion passed and if the child was asked to sit on the toilet by parent or if the child initiated a request to use the toilet. This will allow us to differentiate spontaneous, urge initiated bowel motions.
Timepoint [1] 321965 0
Primary timepoints for outcome analysis will be at recruitment, 6 weeks post intervention commencement, and 2 weeks post cessation of intervention
Secondary outcome [1] 376835 0
Mean number of soiling accidents per week will be measured by means of a bowel diary. The bowel diary is designed to gather information on whether the stool passed was a soiling accident.
Timepoint [1] 376835 0
Mean number of soiling accidents per week will be assessed at recruitment, 6 weeks post commencement of intervention, and 2 weeks post cessation of intervention
Secondary outcome [2] 376836 0
Neurogenic Bowel Dysfunction Score - a composite score made up of symptoms around defecation - bowel incontinence, abdominal pain during defecation, time spent passing stool
Timepoint [2] 376836 0
NBD scores will be assessed at recruitment, 6 weeks post commencement of intervention, and 2 weeks post cessation of intervention

Eligibility
Key inclusion criteria
Children between age 5 and 15 referred to Waikato DHB(New Zealand) Paediatric Outpatient Service with Constipation
Primary diagnosis of chronic idiopathic constipation (Functional Constipation) by clinician
Minimum age
5 Years
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with an identified organic cause for constipation - namely:
Cystic Fibrosis
Hirschsprung's disease
Spinal Malformations
Known anorectal malformations
Previous surgery for constipation including appendicostomy but not including manual evacuation
Patients with a recent admission for nasogastric washout of constipation within the last 6 weeks
Children where cosnsent can't be reasonably obtained

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
NIL
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The statistical analyses will be performed using the SPSS 20.0 statistical software. Continuous data will be represented by the mean, standard deviation, median, minimum value, and maximum value. Categorical data will be represented numerically and by percentage.

For the data with normal distribution, the t test will be used for continuous data, rank sum for nonparametric continuous data, and Chi square test for categorical data. Regression analysis will also be performed with covariates analysed including compliance to medication/stimulation therapy, age of child and type of laxatives used (lactulose vs PEG, presence/absence of stimulant laxative).

The primary outcome to be analysed is the number of spontaneous bowel motions/week. This will be analysed as a continuous variable with 2-sided t tests. A P value <.05 will be considered statistically significant.

A further sub analysis will be conducted specifically looking at the children who started the trial with less than 3 spontaneous bowel motions a week. In this group, time to achievement of >3 SBMs/week will be plotted with a Kaplan-Meier method and a comparison will be made between the treatment and control arms.

As a significant proportion of children do not fulfil ROME IV criteria for chronic idiopathic constipation and present with >3 bowel motions a week. Quality of life measures based on the Neurogenic Bowel Dysfunction Score will be analysed to assess success of treatment in this group.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2020
Actual
Date of last participant enrolment
Anticipated
1/08/2021
Actual
Date of last data collection
Anticipated
1/02/2021
Actual
Sample size
Target
108
Accrual to date
Final
Recruitment outside Australia
Country [1] 22107 0
New Zealand
State/province [1] 22107 0
Waikato

Funding & Sponsors
Funding source category [1] 304254 0
Government body
Name [1] 304254 0
Waikato DHB
Country [1] 304254 0
New Zealand
Primary sponsor type
Government body
Name
Waikato DHB
Address
Attention: Waikato Medical Research Foundation
Peter Rothwell Building
Waikato Hospital
Pembroke Street
Hamilton NZ 3206
Country
New Zealand
Secondary sponsor category [1] 304827 0
None
Name [1] 304827 0
Address [1] 304827 0
Country [1] 304827 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304709 0
Health and Disability Ethics Committee
Ethics committee address [1] 304709 0
133 Molesworth Street
Thorndon
Wellington 6011
Ethics committee country [1] 304709 0
New Zealand
Date submitted for ethics approval [1] 304709 0
11/12/2019
Approval date [1] 304709 0
16/04/2020
Ethics approval number [1] 304709 0
20/NTB/8

Summary
Brief summary
This study aims to study a new management approach for the treatment of severe, longstanding constipation in children. 3-5% of paediatric clinic referrals every year is for the purpose of longstanding constipation. Many children continue to require long term laxatives which can be a difficult to administer and often unpleasant form of treatment.

We wish to study the efficacy and safety of small battery powered devices that administer transcutaneous electric stimulation (TES). TES involves the application of gentle pulsatile electric currents on the abdomen with the aim to stimulate improved contraction of the large intestine. We hope to see an improvement in the average number of bowel motions passed per week in the treatment group and hope to bring forth this treatment as one of the many tools available to clinicians to treat severe constipation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 97950 0
Dr Vivek Rajasekaran
Address 97950 0
Waikids health
Elizabeth Rothwell Building Level 6
Waikato Hospital
Pembroke & Selwyn Street
Hamilton
NZ 3206
Country 97950 0
New Zealand
Phone 97950 0
+64 78398899
Fax 97950 0
Email 97950 0
[email protected]
Contact person for public queries
Name 97951 0
Vivek Rajasekaran
Address 97951 0
Waikids health
Elizabeth Rothwell Building Level 6
Waikato Hospital
Pembroke & Selwyn Street
Hamilton
NZ 3206
Country 97951 0
New Zealand
Phone 97951 0
+64 78398899
Fax 97951 0
Email 97951 0
[email protected]
Contact person for scientific queries
Name 97952 0
Vivek Rajasekaran
Address 97952 0
Waikids health
Elizabeth Rothwell Building Level 6
Waikato Hospital
Pembroke & Selwyn Street
Hamilton
NZ 3206
Country 97952 0
New Zealand
Phone 97952 0
+64 78398899
Fax 97952 0
Email 97952 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We have not specifically sought ethical approval for the publication of individual participant data outside the district health board servers.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6196Study protocol    378723-(Uploaded-17-12-2019-06-33-35)-Study-related document.docx



Results publications and other study-related documents

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