Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02581254
Registration number
NCT02581254
Ethics application status
Date submitted
15/10/2015
Date registered
20/10/2015
Titles & IDs
Public title
Thin Wire Versus Thick Wire Snare for Cold Snare Polypectomy of Diminutive Polyps
Query!
Scientific title
Thin Wire Versus Thick Wire Snare for Cold Snare Polypectomy of Diminutive Polyps- A Randomised Controlled Trial
Query!
Secondary ID [1]
0
0
HREC/15/WMEAD/97 (4237)
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Polyps
0
0
Query!
Condition category
Condition code
Other
0
0
0
0
Query!
Research that is not of generic health relevance and not applicable to specific health categories listed above
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Experimental: Thin Wire Snare Arm - Use of Thin Wire Snare to resect polyp \<10mm
Experimental: Thick Wire Snare Arm - Use of Thick Wire Snare to resect polyp \<10mm
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Incomplete resection rate of diminutive polyps
Query!
Assessment method [1]
0
0
biopsies of the margin are analysed histologically and if any adenoma is found on biopsy, this means the resection with the cold snare was incomplete
Query!
Timepoint [1]
0
0
1 year
Query!
Primary outcome [2]
0
0
Percentage of protrusions
Query!
Assessment method [2]
0
0
cold snare polypectomy can leave a protrusion in the defect, which has previously been shown to be bunched up submucosa. We will record after every polypectomy if a protrusion was visible and if it depends on the snare whether a protrusion occurs or not
Query!
Timepoint [2]
0
0
1 year
Query!
Secondary outcome [1]
0
0
Measurement of the need for second excision in case of endoscopically visual residual adenoma
Query!
Assessment method [1]
0
0
If there is visible adenoma left after excision, then it is in the patient's best interest that this is resected at the time of the colonoscopy. We record in which cases this was necessary and if it occurred more often with 1 snare type than the other
Query!
Timepoint [1]
0
0
1 year
Query!
Secondary outcome [2]
0
0
Post polypectomy bleeding requiring intervention
Query!
Assessment method [2]
0
0
We will record if there is any rectal bleeding after the colonoscopy and if this required re-intervention to stop the bleeding. We will record if this was more prevalent with 1 snare type.
Query!
Timepoint [2]
0
0
1 year
Query!
Eligibility
Key inclusion criteria
* Patients able to give informed consent to involvement in trial. For patients who do not speak English, an interpreter will be asked to translate the informed consent
* Patients referred to Auburn Hospital Endoscopy Unit for a colonoscopy for whatever reason
* At least 1 lesion <10mm beyond the rectosigmoid junction without any endoscopic features of malignancy
* At least 1 lesion <10mm beyond the rectosigmoid junction that according to the proceduralist, can be safely removed with CSP
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
Yes
Query!
Key exclusion criteria
* Current use of antiplatelets (excluding aspirin) or anticoagulants which have not appropriately been interrupted
* Known coagulopathy
* Pregnancy
* If any doubt about the benign character of the polyp, the patient will be excluded from the study
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
NA
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/07/2015
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/07/2021
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
660
Query!
Recruitment in Australia
Recruitment state(s)
NSW
Query!
Recruitment hospital [1]
0
0
Auburn Hosptial - Auburn
Query!
Recruitment postcode(s) [1]
0
0
2144 - Auburn
Query!
Funding & Sponsors
Primary sponsor type
Other
Query!
Name
Western Sydney Local Health District
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
Cold snare polypectomy (CSP) is now common practice and has proven to be a safe and effective technique for removal of diminutive polyps. Both thick and thin wire snares are now commonly used for CSP. However, because of their physical characteristics, thick wire snares might leave a higher percentage of residual adenoma at the resection site. Since this may result in a higher risk of recurrence, the technique needs to be optimized. Experts have suggested that a thin wire snare might be more efficient, with a lower risk of residual adenoma at the resection site and consequently a lower risk of recurrence and interval cancer.
Query!
Trial website
https://clinicaltrials.gov/study/NCT02581254
Query!
Trial related presentations / publications
Sidhu M, Forbes N, Tate DJ, Desomer L, Lee EYT, Burgess N, van Hattem A, Mcleod D, Cheng E, Cartwright S, Schell A, Hilsden RJ, Heitman SJ, Bourke MJ. A Randomized Controlled Trial of Cold Snare Polypectomy Technique: Technique Matters More Than Snare Wire Diameter. Am J Gastroenterol. 2022 Jan 1;117(1):100. doi: 10.14309/ajg.0000000000001554.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Eric Dr Lee, FRACP
Query!
Address
0
0
Westmead Hospital
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02581254