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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cold polypectomy | Active Comparator | 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. |
|
| Hot polypectomy | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polypectomy | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Factors explaining the primary outcome |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35008112 | Derived | 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. |
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| ID | Term |
|---|---|
| D003111 | Colonic Polyps |
| D015179 | Colorectal Neoplasms |
| D000236 | Adenoma |
| ID | Term |
|---|---|
| D007417 | Intestinal Polyps |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Patient characteristics |
| During the hospital stay and up to 4 weeks. |
| Factors explaining the primary outcome | Doctor characteristics | During the hospital stay and up to 4 weeks |
| Factors explaining the primary outcome | Procedure characteristics | During the hospital stay and up to 4 weeks |
| 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 |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |