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

• Sponsor: Sorlandet Hospital HF (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT02484079
• Collaborator: (none)
• Enrollment: 429
• Arms: 2
• Anticipated Duration (Months): 90.5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Colonic Polyps; Colorectal Neoplasms; Adenoma	Procedure: Polypectomy	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 429 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Comparative Effectiveness of Hot Versus Cold Snare Polypectomy of Small Colorectal Polyps. A Randomized Controlled Trial
• Actual Study Start Date: May 18, 2015
• Actual Primary Completion Date: May 20, 2020
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Cold polypectomy 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.	Procedure: Polypectomy
Active Comparator: Hot polypectomy 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.	Procedure: Polypectomy

Outcome Measures

Primary Outcome Measures

1. Complete resection rate [Hopefully within 4 weeks, when the histopathologist has examined the biopsies]

   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.

Secondary Outcome Measures

1. Complications [4 weeks]

   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

2. Factors explaining the primary outcome [During the hospital stay and up to 4 weeks.]

   Patient characteristics

3. Factors explaining the primary outcome [During the hospital stay and up to 4 weeks]

   Doctor characteristics

4. Factors explaining the primary outcome [During the hospital stay and up to 4 weeks]

   Procedure characteristics

5. Factors explaining the primary outcome [During the hospital stay and up to 4 weeks]

   Histology of polyps, correlation between resection margins and biopsies, correlation between optical and histopathological diagnosis

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Sorlandet Hospital HF

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sorlandet Hospital HF
• ClinicalTrials.gov Identifier: NCT02484079
• Other Study ID Numbers: SorlandetHF
• First Posted: Jun 29, 2015
• Last Update Posted: Jul 13, 2021
• Last Verified: Jul 1, 2021

• Additional relevant MeSH terms: Adenoma; Colorectal Neoplasms; Polyps; Colonic Polyps

Study Results

No Results Posted as of Jul 13, 2021