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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02967107




Registration number
NCT02967107
Ethics application status
Date submitted
13/08/2016
Date registered
17/11/2016

Titles & IDs
Public title
Cold Snare Polypectomy Versus Endoscopic Mucosal Resection for Colonic Sessile Serrated Polyps
Scientific title
Cold Snare Polypectomy Versus Endoscopic Mucosal Resection for Colonic Sessile Serrated Polyps - A Randomised Controlled Trial
Secondary ID [1] 0 0
HREC/15/WMEAD/507
Universal Trial Number (UTN)
Trial acronym
CSP-EMR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal Cancer 0 0
Adenoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Metabolic and Endocrine 0 0 0 0
Other endocrine disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Cold snare polypectomy
Treatment: Surgery - Endoscopic mucosal resection

Active comparator: Cold snare polypectomy - Cold snare resection, if necessary, multi-piece to resect sessile serrated adenoma (SSA) 8-20mm

Active comparator: Endoscopic mucosal resection - Endoscopic mucosal resection (EMR), if necessary, multi-piece to resect sessile serrated adenoma (SSA) 8-20mm


Treatment: Surgery: Cold snare polypectomy
Use of a polypectomy snare closed over a polyp without electrocautery

Treatment: Surgery: Endoscopic mucosal resection
Use of injected chromogelofusine solution to raise a lesion prior to snare resection with electrocautery
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with residual or recurrent adenoma as assessed at surveillance endoscopy
Timepoint [1] 0 0
4-6 months
Secondary outcome [1] 0 0
Number of participants with bleeding after the EMR procedure has finished as assessed by telephone interview at 2 weeks
Timepoint [1] 0 0
2 weeks
Secondary outcome [2] 0 0
Number of participants with residual or recurrent adenoma as assessed at admission or telephone interview at 2 weeks
Timepoint [2] 0 0
2 weeks
Secondary outcome [3] 0 0
Number of participants with pain after EMR as assessed by VAS score and telephone interview at 2 weeks
Timepoint [3] 0 0
2 weeks

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 Westmead and Auburn Hospital Endoscopy Unit for a colonoscopy for all indications
* Age > 18 years
* At least one SSP 8-20 mm beyond the rectosigmoid junction without any endoscopic features of malignancy
* At least one SSP 8-20 mm beyond the rectosigmoid junction that according to the proceduralist, can be removed safely using either CSP or EMR
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Current use of antiplatelets (excluding aspirin) or anticoagulants which have not appropriately been interrupted according to the guidelines [21]
* Known coagulopathy
* Pregnancy
* If any doubt about the morphology 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2022
Sample size
Target
Accrual to date
Final
474
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
2145 - Westmead

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

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


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/NCT02967107