Clinical trial NCT02484079: Comparative Effectiveness of Hot Versus Cold Snare Polypectomy of Small Colorectal Polyps
Official title: Comparative Effectiveness of Hot Versus Cold Snare Polypectomy of Small Colorectal Polyps. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonic Polyps
Colorectal Neoplasms
Adenoma
Lead sponsor: Sorlandet Hospital HF
Sponsor class: OTHER_GOV
First posted: 2015-06-29
Enrollment: 429
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Complete resection rate
timeFrame: Hopefully within 4 weeks, when the histopathologist has examined the biopsies
Secondary outcomes:
measure: Complications
timeFrame: 4 weeks
measure: Factors explaining the primary outcome
timeFrame: During the hospital stay and up to 4 weeks.
measure: Factors explaining the primary outcome
timeFrame: During the hospital stay and up to 4 weeks
measure: Factors explaining the primary outcome
timeFrame: During the hospital stay and up to 4 weeks
measure: Factors explaining the primary outcome
timeFrame: During the hospital stay and up to 4 weeks
Other outcomes:
Locations:
Study officials:
References:
citation: Pedersen IB, Rawa-Golebiewska A, Calderwood AH, Brix LD, Grode LB, Botteri E, Bugajski M, Kaminski MF, Januszewicz W, Odegaard H, Kleist B, Kalager M, Loberg M, Bretthauer M, Hoff G, Medhus A, Holme O. Complete polyp resection with cold snare versus hot snare polypectomy for polyps of 4-9 mm: a randomized controlled trial. Endoscopy. 2022 Oct;54(10):961-969. doi: 10.1055/a-1734-7952. Epub 2022 Jan 10.