Comparative Effectiveness of Hot Versus Cold Snare Polypectomy of Small Colorectal Polyps

Colorectal Neoplasms Clinical Trial

— HOT/COLD  

Official title:

Comparative Effectiveness of Hot Versus Cold Snare Polypectomy of Small Colorectal Polyps. A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02484079
• Other study ID #: SorlandetHF
• Status: Completed
• Phase: N/A
• Start date: May 18, 2015
• Est. completion date: December 31, 2022

Study information

• Verified date: December 2021
• Source: Sorlandet Hospital HF
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 429
• Est. completion date: December 31, 2022
• Est. primary completion date: May 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Colonic Polyps
• Colorectal Neoplasms
• Polyps

Intervention

Procedure:
• Polypectomy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sorlandet Hospital HF

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete resection rate	We want to measure the rate of polyps that are resected completely, both with biopsies from the margin and the histopathologists evaluation of the resection margins of the polyp itself.	Hopefully within 4 weeks, when the histopathologist has examined the biopsies
Secondary	Complications	We want to register early (during the procedure) and late (within 4 weeks after the procedure) complications.; Complications we will record is bleeding/blood in the stool, perforation and patient contact with health care provider	4 weeks
Secondary	Factors explaining the primary outcome	Patient characteristics	During the hospital stay and up to 4 weeks.
Secondary	Factors explaining the primary outcome	Doctor characteristics	During the hospital stay and up to 4 weeks
Secondary	Factors explaining the primary outcome	Procedure characteristics	During the hospital stay and up to 4 weeks
Secondary	Factors explaining the primary outcome	Histology of polyps, correlation between resection margins and biopsies, correlation between optical and histopathological diagnosis	During the hospital stay and up to 4 weeks