NCT Number: NCT02484079
Comparative Effectiveness of Hot Versus Cold Snare Polypectomy of Small Colorectal Polyps
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.
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Notify MeKey information
Conditions
Age range
40 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
Complete resection rate
Time frame: 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 outcomes
-
Complications
Time frame: 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
-
Factors explaining the primary outcome
Time frame: During the hospital stay and up to 4 weeks.
Patient characteristics
-
Factors explaining the primary outcome
Time frame: During the hospital stay and up to 4 weeks
Doctor characteristics
-
Factors explaining the primary outcome
Time frame: During the hospital stay and up to 4 weeks
Procedure characteristics
-
Factors explaining the primary outcome
Time frame: During the hospital stay and up to 4 weeks
Histology of polyps, correlation between resection margins and biopsies, correlation between optical and histopathological diagnosis
Sponsors and collaborators
Lead sponsor
Sorlandet Hospital HF
Other Gov
Registry information
Official study title
Comparative Effectiveness of Hot Versus Cold Snare Polypectomy of Small Colorectal Polyps. A Randomized Controlled Trial
Acronym: HOT/COLD
Important dates
- Study start
- 2015
- Primary completion
- 2020
- Study completion
- 2022
- First posted
- Jun 29, 2015
- Registry last updated
- Feb 23, 2023
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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