Soft Coagulation for the Prevention of Adenoma Recurrence

Colonic Adenomas Clinical Trial

— SCAR  

Official title:

Soft Coagulation for the Prevention of Adenoma Recurrence After Endoscopic Mucosal Resection (EMR) of Large Sessile Colonic Polyps: A Multicentre, Randomized Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01789749
• Other study ID #: HREC/12/WMEAD/139
• Secondary ID: HREC2012/5/4.6 (
• Status: Completed
• Phase: N/A
• Start date: July 2013
• Est. completion date: December 16, 2016

Study information

• Verified date: March 2021
• Source: Western Sydney Local Health District
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 455
• Est. completion date: December 16, 2016
• Est. primary completion date: May 16, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Referred for removal of a colonic polyp >= 20mm in size
• Able to give informed consent to involvement in trial

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

Related Conditions & MeSH terms

• Adenoma
• Colonic Adenomas
• Recurrence

Intervention

Other:
• Snare Tip Soft Coagulation

• No Snare Tip Soft Coagulation

Locations

Country	Name	City	State
Australia	Lyell McEwin Hospital	Adelaide	South Australia
Australia	Princess Alexandra Hospital	Brisbane	Queensland
Australia	The Alfred Hospital	Melbourne	VA
Australia	Westmead Endoscopy Unit	Westmead	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Professor Michael Bourke

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endoscopic recurrence	Presence of residual/recurrent adenoma at the EMR scar at endoscopic follow-up	4-6 months and 18 months
Secondary	Histologic recurrence	Presence of residual/recurrent adenoma on biopsy of the endoscopic resection scar	4-6 months and 18 months
Secondary	En bloc resection	Rate of 'en bloc resection' (removing entire lesion in one snare) with histologically confirmed clear margins	Index procedure
Secondary	Snare resections	The number of snare resections needed to achieve complete clearance	Index procedure
Secondary	Duration	Time required for EMR	Index procedure
Secondary	Perforation during EMR	Perforation during EMR	During index procedure
Secondary	Post EMR bleeding	Bleeding after EMR requiring admission or repeat intervention	Post Index procedure
Secondary	Number of injections for hemostasis	Number of injections required for haemostasis	Index procedure, if post EMR bleeding
Secondary	Location of bleeding vessels	Location of bleeding vessels	Index procedure, if post EMR bleeding
Secondary	Size/number of bleeding vessels	Size/number of bleeding vessels	Index procedure, if post EMR bleeding
Secondary	Delayed perforation	Delayed perforation requiring intervention or readmission	After index procedure
Secondary	Readmission	Readmission after index procedure	After index procedure