Prevention of Post-Polypectomy Colorectal Bleeding by Clips in Patients on Anticoagulants

Официальное название

Prevention of Post-Polypectomy Colorectal Bleeding by Clips in Patients on Anticoagulants: a Retrospective Single Center Propensity Score Analysis

Обзор

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.

Подробное описание

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).

Вмешательства

• Устройство Hemostatic clip
  The hemostatic clip is endoscopically applied after a colorectal polypectomy to close the mucosal defect.

Первичные конечные точки

• Colorectal Post-polypectomy bleeding [Срок оценки: Up to 30 days after colorectal endoscopic polypectomy]

Критерии участия

Критерии включения

• adult who has received a colonoscopy with endoscopic colorectal polypectomy
• patient who has received at least one anticoagulant after polypectomy

Критерии исключения

• Endoscopic polypectomy was combined with closure of the mucosal defect by a suturing device or full thickness resection device

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Германия · 1 центр

• Helios Kliniken Schwerin — Schwerin

Публикации

• 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. PMID 39722137
• 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 res PMID 38670139

Идентификаторы

NCT: NCT07007598 · HeliosSchwerin GAS 01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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