Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001329954
Ethics application status
Approved
Date submitted
2/10/2020
Date registered
9/12/2020
Date last updated
9/12/2020
Date data sharing statement initially provided
9/12/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of two different suction rectal biopsy forceps for the diagnosis of Hirschsprung disease in children: A randomised controlled trial
Scientific title
Efficacy of reusable suction rectal biopsy forceps (rbi2®) versus disposable suction rectal biopsy forceps (SBT 200®) for the diagnosis of Hirschsprung disease: A randomised controlled trial
Secondary ID [1] 302461 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hirschsprung disease 319290 0
Condition category
Condition code
Oral and Gastrointestinal 317257 317257 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Surgery 317258 317258 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Infants randomised into the SBT200® group, will undergo suction rectal biopsy with a fully disposable SBT200® SRB forceps.
The suction rectal biopsy is a standard procedure performed in children with suspected Hirschsprung disease.
The time take for the biopsy is normally 20 minutes.
The biopsy will be taken by a paediatric surgeon.
Intervention code [1] 318753 0
Diagnosis / Prognosis
Comparator / control treatment
Infants randomised into the rbi2® group, will undergo suction rectal biopsy with the reusable SRB forceps and disposable rbi2® cartridges.

The suction rectal biopsy is a standard procedure performed in children with suspected Hirschsprung disease. The reusable SRB forceps and disposable rbi2® cartridges are currently routinely used at Monash Children's hospital.
The time take for the biopsy is normally 20 minutes.
The biopsy will be taken by a paediatric surgeon.
Control group
Active

Outcomes
Primary outcome [1] 325313 0
Number of inadequate specimens obtained on histological examination (lack of submucosa in the specimen).
Timepoint [1] 325313 0
Within 7 days from the biopsy procedure.
Primary outcome [2] 325314 0
Number of biopsies attempted at each episode recorded by the operating surgeon in the operating notes.
Timepoint [2] 325314 0
Within 7 days from the biopsy procedure.
Primary outcome [3] 325315 0
Number of biopsy episodes performed recorded by the operating surgeon in the operating notes.
Timepoint [3] 325315 0
Within 7 days from the biopsy procedure.
Secondary outcome [1] 387476 0
Bleeding (requiring blood transfusion). Obtained from the medical records.
Timepoint [1] 387476 0
Within 24 hours from the biopsy procedure.
Secondary outcome [2] 388632 0
Rectal perforation. Obtained from the medical records.
Timepoint [2] 388632 0
Within 7 days from the biopsy procedure.
Secondary outcome [3] 388633 0
Pelvic abscess. Obtained from the medical records.
Timepoint [3] 388633 0
Within 7 days from the biopsy procedure.
Secondary outcome [4] 388634 0
Sepsis. Obtained from the medical records.
Timepoint [4] 388634 0
Within 7 days from the biopsy procedure.

Eligibility
Key inclusion criteria
All infants less than 6 months of age requiring a suction rectal biopsy to confirm the diagnosis of Hirschsprung disease will be eligible for the study.
Minimum age
0 Days
Maximum age
6 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
All infants over 6 months of age, those infants who have significant co morbidities such as cardiovascular instability and bleeding diathesis will be excluded from the study.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be randomized according to weighted minimization; variables for minimization will include: gender and weight.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/12/2020
Date of last participant enrolment
Anticipated
15/06/2022
Actual
Date of last data collection
Anticipated
15/07/2022
Actual
Sample size
Target
40
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 306887 0
Commercial sector/Industry
Name [1] 306887 0
Trewavis Surgical Instruments Pty. Limited.
Country [1] 306887 0
Australia
Primary sponsor type
Hospital
Name
Monash Health
Address
246 Clayton Road
Clayton
Victoria 3168
Country
Australia
Secondary sponsor category [1] 307445 0
None
Name [1] 307445 0
Address [1] 307445 0
Country [1] 307445 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307044 0
Monash Health Research Ethics Committee
Ethics committee address [1] 307044 0
Research Support Services
Level 2, I Block
Monash Medical Centre
246 Clayton Road, Clayton, 3168
Ethics committee country [1] 307044 0
Australia
Date submitted for ethics approval [1] 307044 0
15/10/2020
Approval date [1] 307044 0
10/11/2020
Ethics approval number [1] 307044 0
ES-20-0000-817A

Summary
Brief summary
A randomised controlled trial (RCT) will be conducted at Monash Children’s Hospital on infants less than 6 months of age with suspected Hirschsprung disease, requiring a suction rectal biopsy. The study will be an open-label (unblinded) randomised controlled trial: due to the nature of the intervention (i.e. different appearance of the rbi2® and SBT200®) biopsy forceps blinding is not possible.
The hypothesis to be tested is that the SBT200® SRB forceps will have lower rates of inadequate specimen sampling, lower re-biopsy rates and lower or comparable complication rates.
The proposed sample size for this trial is 40 children in total with 20 in each arm. Since the SBT200® is a brand-new device, no data is available regarding the rate of insufficient biopsy. The sample size has been chosen on feasibility based on the number of patients investigated for Hirschsprung disease each year at Monash Children’s Hospital (20-30) with the aim of completing the trial within 18-24 months.
Primary endpoints for the trial will be the effectiveness and the complications with each SRB forceps
- Number of biopsies attempted at each episode
- Number of inadequate specimens obtained
- Number of biopsy episodes performed
- Complications:
o Bleeding requiring admission/blood transfusion
o Rectal perforation
o Pelvic abscess/sepsis
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 105830 0
Dr Maurizio Pacilli
Address 105830 0
Department of Paediatric Surgery
Level 5, Monash Children's Hospital
246 Clayton Road
Clayton Vic 3168
Country 105830 0
Australia
Phone 105830 0
+61385723837
Fax 105830 0
Email 105830 0
maurizio.pacilli@monash.edu
Contact person for public queries
Name 105831 0
Dr Maurizio Pacilli
Address 105831 0
Department of Paediatric Surgery
Level 5, Monash Children's Hospital
246 Clayton Road
Clayton Vic 3168
Country 105831 0
Australia
Phone 105831 0
+61385723837
Fax 105831 0
Email 105831 0
maurizio.pacilli@monash.edu
Contact person for scientific queries
Name 105832 0
Dr Maurizio Pacilli
Address 105832 0
Department of Paediatric Surgery
Level 5, Monash Children's Hospital
246 Clayton Road
Clayton Vic 3168
Country 105832 0
Australia
Phone 105832 0
+61385723837
Fax 105832 0
Email 105832 0
maurizio.pacilli@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The data might contain intellectual property.


What supporting documents are/will be available?

No Supporting Document Provided



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.