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

NCT ID: NCT07007598

Last Updated: 2025-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-01

Study Completion Date

2026-11-01

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Polyp of Colon

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Colorectal polypectomy and prophylactic clipping before restarted anticoagulants

At least one prophylactic clip is applied to close the mucosal defect after polypectomy

Hemostatic clip

Intervention Type DEVICE

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

Colorectal polypectomy without prophylactic clipping before restarted anticoagulant

A prophylactic clip is not applied to close the mucosal defect after polypectomy.

No interventions assigned to this group

Interventions

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Hemostatic clip

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical School Hamburg

OTHER

Sponsor Role collaborator

Helios Kliniken Schwerin

OTHER

Sponsor Role lead

Responsible Party

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Dr. med. Daniel Schmitz

Head Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Daniel Schmitz, Dr.med.

Role: PRINCIPAL_INVESTIGATOR

Helios Kliniken Schwerin

Locations

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Helios Kliniken Schwerin

Schwerin, Mecklenburg-Vorpommern, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Daniel Schmitz, Dr. med.

Role: CONTACT

+493855202601

Martin Kliment

Role: CONTACT

+493855202601

Facility Contacts

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Dr.med.Daniel Schmitz, Dr.med.

Role: primary

+493855202601

Martin Kliment

Role: backup

+493855202601

References

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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.

Reference Type BACKGROUND
PMID: 39722137 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38670139 (View on PubMed)

Other Identifiers

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HeliosSchwerin GAS 01

Identifier Type: -

Identifier Source: org_study_id

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