Comparative Effectiveness of Hot Versus Cold Snare Polypectomy of Small Colorectal Polyps (HOT/COLD)

Sorlandet Hospital HF

Status: Completed

Conditions: Colonic Polyps; Colorectal Neoplasms; Adenoma

Treatments: Procedure: Polypectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT02484079

SorlandetHF

Details and patient eligibility

About

This study aims to investigate the comparative effectiveness between polyp removal with or without electrical current. The investigators want to include 600 polyps in the trial.

It is known that polyps have the potential to develop to cancer if left in situ, but the investigators do not know the best way to remove them completely.

Full description

In this study the investigators want to compare to widely used methods for polyp removal; hot and cold snare polypectomy. There has not been performed any big studies on this subject earlier, but current knowledge indicates that hot polypectomy (i.e. with use of electrical current) is somewhat better with regard to complete resection of polyps compared to cold polypectomy (without electrical current).

In this project the patients will be randomized to either hot or cold polypectomy. The investigators will distribute videos of how the polypectomies should be performed, and a gastroenterologist in the project group will instruct the doctors examining the patients to make sure that everyone performs polypectomy according to current guidelines.

The study is designed as a non-inferiority trial.

Enrollment: 429 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Outpatient colonoscopy
• Signed, written informed consent
• At least one flat/sessile polyp sized 4-9 mm identified during colonoscopy

Exclusion criteria

• Implanted cardiac electro converter
• Severe comorbidity (NYHA 3-4)
• Known coagulopathy (INR > 1,8) or resent use of any of the new oral anti-coagulant medications
• Platelet count < 100
• Resent use of clopidogrel or other non-acetylsalicylic acid platelet inhibitor (Last dose < 5 days before the procedure)
• Previous biopsy or attempt of polypectomy of the polyp considered for inclusion in the trial

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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429 participants in 2 patient groups

Cold polypectomy

Active Comparator group

Description:

Patients in this arm will have their polyps removed by cold polypectomy, i.e. a metal sling that is closed around the basis of the polyp, and the polyp is cut off. After removal there will be taken biopsies from the resection margins, and both the polyp and the biopsies will be examined by a histopathologist to see if the polyp is removed completely.

Treatment:

Procedure: Polypectomy

Hot polypectomy

Active Comparator group

Description:

Patients in this arm will have their polyps removed by hot polypectomy, i.e. a metal sling taht is closed around the basis of the polyp, electrical currents is applied, and the polyp is cut off. After removal there will be taken biopsies from the resection margins, and both the polyp and the biopsies will be examined by a histopathologist to see if the polyp is removed completely.

Treatment:

Procedure: Polypectomy