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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02581254




Registration number
NCT02581254
Ethics application status
Date submitted
15/10/2015
Date registered
20/10/2015
Date last updated
4/07/2019

Titles & IDs
Public title
Thin Wire Versus Thick Wire Snare for Cold Snare Polypectomy of Diminutive Polyps
Scientific title
Thin Wire Versus Thick Wire Snare for Cold Snare Polypectomy of Diminutive Polyps- A Randomised Controlled Trial
Secondary ID [1] 0 0
HREC/15/WMEAD/97 (4237)
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Polyps 0 0
Condition category
Condition code
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Thin Wire Snare
Treatment: Devices - Thick Wire Snare

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


Treatment: Devices: Thin Wire Snare


Treatment: Devices: Thick Wire Snare


Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incomplete resection rate of diminutive polyps - 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
Timepoint [1] 0 0
1 year
Primary outcome [2] 0 0
Percentage of protrusions - 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
Timepoint [2] 0 0
1 year
Secondary outcome [1] 0 0
Measurement of the need for second excision in case of endoscopically visual residual adenoma - 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
Timepoint [1] 0 0
1 year
Secondary outcome [2] 0 0
Post polypectomy bleeding requiring intervention - 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.
Timepoint [2] 0 0
1 year

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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
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

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Auburn Hosptial - Auburn
Recruitment postcode(s) [1] 0 0
2144 - Auburn

Funding & Sponsors
Primary sponsor type
Other
Name
Western Sydney Local Health District
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT02581254
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Eric Dr Lee, FRACP
Address 0 0
Westmead Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Lobke Dr Desomer, MD
Address 0 0
Country 0 0
Phone 0 0
+61481578153
Fax 0 0
Email 0 0
lobkedesomer@gmail.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02581254