Clinical trial NCT07007598: Prevention of Post-Polypectomy Colorectal Bleeding by Clips in Patients on Anticoagulants
Official title: Prevention of Post-Polypectomy Colorectal Bleeding by Clips in Patients on Anticoagulants: a Retrospective Single Center Propensity Score Analysis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Polyp of Colon
Keywords: polyps
Hemorrhage
Anticoagulants
Lead sponsor: Helios Kliniken Schwerin
Sponsor class: OTHER
Collaborators: name: Medical School Hamburg
First posted: 2025-06-06
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults who have received an endoscopic colorectal polypectomy

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Colorectal Post-polypectomy bleeding
timeFrame: Up to 30 days after colorectal endoscopic polypectomy
Secondary outcomes:
Other outcomes:
Locations:
city: Schwerin
country: Germany
facility: Helios Kliniken Schwerin
state: Mecklenburg-Vorpommern
Study officials:
affiliation: Helios Kliniken Schwerin
name: Daniel Schmitz, Dr.med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.