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| Name | Class |
|---|---|
| Medical School Hamburg | OTHER |
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This observational study aims to retrospectively determine if clips can prevent post-polypectomy bleeding in adults who have received restarted anticoagulants after a colorectal polypectomy, using a large, single-center patient registry.
The main question it aims to answer is:
Can clips prevent post-polypectomy bleeding in adults who have received restarted anticoagulants after a colorectal polypectomy? Researchers will compare adults who received preventive clipping after a polypectomy with those who did not, regarding colorectal bleeding after receiving restarted anticoagulants.
Participants have undergone a colorectal polypectomy and received restarted anticoagulants (acetylsalicylic acid excluded) after the procedure.
Screening colonoscopy allows early detection of cancer and removal of adenomas before they become malignant. Unresected polyps larger than 1 cm have a 24% risk of invasive adenocarcinoma. Post-polypectomy bleeding is influenced by factors such as polyp size, location, tumor type, anticoagulants and concomitant diseases. Prophylactic measures such as clipping show mixed results; selective clipping is cost-effective, but universal clipping is not. The updated ESGE guideline on colorectal polypectomy and endoscopic mucosal resection from 2024 recommends prophylactic endoscopic clip of the mucosal defect after endoscopic mucosal resection of large non-pedunculated polyps in the right colon to reduce the risk of delayed bleeding. However, there is no clear recommendation for patients on anticoagulants whether to use or not to use prophylactic clipping. Therefore, this observational study aims to retrospectively determine if clips can prevent post-polypectomy bleeding in adults who have received restarted anticoagulants after a colorectal polypectomy, using a large, single-center patient registry (> 10.000 colonoscopies).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colorectal polypectomy and prophylactic clipping before restarted anticoagulants | At least one prophylactic clip is applied to close the mucosal defect after polypectomy |
| |
| Colorectal polypectomy without prophylactic clipping before restarted anticoagulant | A prophylactic clip is not applied to close the mucosal defect after polypectomy. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hemostatic clip | Device | The hemostatic clip is endoscopically applied after a colorectal polypectomy to close the mucosal defect. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Colorectal Post-polypectomy bleeding | Mucosal defect-associated bleeding after removal of a colorectal polyp bei endoscopic polypectomy. The metachronous interval bleeding rate is calculated by dividing the number of bleeding events by the number of colonoscopies with polypectomy. The following are counted as polypectomy bleeding:
| Up to 30 days after colorectal endoscopic polypectomy |
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Inclusion Criteria:
Exclusion Criteria:
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Adults who have received an endoscopic colorectal polypectomy
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniel Schmitz, Dr. med. | Contact | +493855202601 | Daniel.Schmitz@helios-gesundheit.de | |
| Martin Kliment | Contact | +493855202601 | Martin.Kliment@helios-gesundheit.de |
| Name | Affiliation | Role |
|---|---|---|
| Daniel Schmitz, Dr.med. | Helios Kliniken Schwerin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helios Kliniken Schwerin | Recruiting | Schwerin | Mecklenburg-Vorpommern | 19055 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39722137 | Background | Nishad N, Thoufeeq MH. Post-polypectomy colorectal bleeding: current strategies and the way forward. Clin Endosc. 2025 Mar;58(2):191-200. doi: 10.5946/ce.2024.241. Epub 2024 Nov 27. | |
| 38670139 | Background | Ferlitsch M, Hassan C, Bisschops R, Bhandari P, Dinis-Ribeiro M, Risio M, Paspatis GA, Moss A, Libanio D, Lorenzo-Zuniga V, Voiosu AM, Rutter MD, Pellise M, Moons LMG, Probst A, Awadie H, Amato A, Takeuchi Y, Repici A, Rahmi G, Koecklin HU, Albeniz E, Rockenbauer LM, Waldmann E, Messmann H, Triantafyllou K, Jover R, Gralnek IM, Dekker E, Bourke MJ. Colorectal polypectomy and endoscopic mucosal resection: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - Update 2024. Endoscopy. 2024 Jul;56(7):516-545. doi: 10.1055/a-2304-3219. Epub 2024 Apr 26. |
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| ID | Term |
|---|---|
| D003111 | Colonic Polyps |
| D011127 | Polyps |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D007417 | Intestinal Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |
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