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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01789749




Registration number
NCT01789749
Ethics application status
Date submitted
28/11/2012
Date registered
12/02/2013
Date last updated
23/03/2021

Titles & IDs
Public title
Soft Coagulation for the Prevention of Adenoma Recurrence
Scientific title
Soft Coagulation for the Prevention of Adenoma Recurrence After Endoscopic Mucosal Resection (EMR) of Large Sessile Colonic Polyps: A Multicentre, Randomized Trial.
Secondary ID [1] 0 0
HREC2012/5/4.6 (3512)
Secondary ID [2] 0 0
HREC/12/WMEAD/139
Universal Trial Number (UTN)
Trial acronym
SCAR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colonic Adenomas 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
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
Active comparator: No Coagulation Arm - Patients do not receive Snare Tip Soft Coagulation to the edge of the endoscopic resection defect

Experimental: Coagulation Arm - Patients to receive Snare Tip Soft Coagulation to the edge of the endoscopic resection defect
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Endoscopic recurrence
Timepoint [1] 0 0
4-6 months and 18 months
Secondary outcome [1] 0 0
Histologic recurrence
Timepoint [1] 0 0
4-6 months and 18 months
Secondary outcome [2] 0 0
En bloc resection
Timepoint [2] 0 0
Index procedure
Secondary outcome [3] 0 0
Snare resections
Timepoint [3] 0 0
Index procedure
Secondary outcome [4] 0 0
Duration
Timepoint [4] 0 0
Index procedure
Secondary outcome [5] 0 0
Perforation during EMR
Timepoint [5] 0 0
During index procedure
Secondary outcome [6] 0 0
Post EMR bleeding
Timepoint [6] 0 0
Post Index procedure
Secondary outcome [7] 0 0
Number of injections for hemostasis
Timepoint [7] 0 0
Index procedure, if post EMR bleeding
Secondary outcome [8] 0 0
Location of bleeding vessels
Timepoint [8] 0 0
Index procedure, if post EMR bleeding
Secondary outcome [9] 0 0
Size/number of bleeding vessels
Timepoint [9] 0 0
Index procedure, if post EMR bleeding
Secondary outcome [10] 0 0
Delayed perforation
Timepoint [10] 0 0
After index procedure
Secondary outcome [11] 0 0
Readmission
Timepoint [11] 0 0
After index procedure

Eligibility
Key inclusion criteria
* Referred for removal of a colonic polyp >= 20mm in size
* Able to give informed consent to involvement in trial
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Younger than 18 years of age
* Highly dependant on medical care
* Women who are pregnant or may be pregnant.
* Taken clopidogrel within 7 days
* Taken warfarin within 5 days
* Had full therapeutic dose unfractionated heparin within 6 hours
* Had full therapeutic dose low molecular weight heparin (LMWH) within 12 hours
* Known clotting disorder
* Previous attempt at EMR of the polyp referred for resection
* Polyp located at the ileo-caecal valve, appendiceal orifice
* Fully circumferential polyp
* Incomplete snare resection of the polyp

Study design
Purpose of the study
Prevention
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


Intervention assignment
Parallel
Other design features
Phase
Not applicable
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
1/07/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
16/12/2016
Sample size
Target
Accrual to date
Final
455
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,V
Recruitment hospital [1] 0 0
Westmead Endoscopy Unit - Westmead
Recruitment hospital [2] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [3] 0 0
Lyell McEwin Hospital - Adelaide
Recruitment hospital [4] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
- Brisbane
Recruitment postcode(s) [3] 0 0
- Adelaide
Recruitment postcode(s) [4] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Professor Michael Bourke
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Recurrence after endoscopic mucosal resection of laterally spreading lesions (LSL) \>= 20mm in size occurs in approximately 20% of cases at surveillance colonoscopy. We aim to evaluate the efficacy of prophylactic adjuvant thermal ablation of the EMR mucosal defect margin in reducing adenoma recurrence following colonic EMR.
Trial website
https://clinicaltrials.gov/study/NCT01789749
Trial related presentations / publications
Klein A, Tate DJ, Jayasekeran V, Hourigan L, Singh R, Brown G, Bahin FF, Burgess N, Williams SJ, Lee E, Sidhu M, Byth K, Bourke MJ. Thermal Ablation of Mucosal Defect Margins Reduces Adenoma Recurrence After Colonic Endoscopic Mucosal Resection. Gastroenterology. 2019 Feb;156(3):604-613.e3. doi: 10.1053/j.gastro.2018.10.003. Epub 2018 Oct 6.
Public notes

Contacts
Principal investigator
Name 0 0
Michael Bourke, FRACP, MBBS
Address 0 0
Western SLHD
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01789749