Adenoma, Colonic Polyps, Colorectal Neoplasms
Conditions
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.
Interventions
PROCEDUREPolypectomy
Sponsors
Sorlandet Hospital HF
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Factors explaining the primary outcome | During the hospital stay and up to 4 weeks. | Patient characteristics |
Outcome results
None listed