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

NCT07007598 | Recruiting

• 1 other identifier: HeliosSchwerin GAS 01
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Polyp of Colon

Keywords

polyps; Hemorrhage; Anticoagulants

Outcome Measures

Primary Outcomes (1)

• 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: 1. Polypectomy bleeding is visualized directly during a subsequent colonoscopy. 2. Polypectomy bleeding is considered probable if a subsequent colonoscopy is performed due to lower gastrointestinal bleeding, and evidence of blood is found in association with the polypectomy. 3. Polypectomy bleeding is considered probable if the patient was hospitalized for monitoring or had his hospital stay extended because he showed visible perianal bleeding. However, a colonoscopy was not performed because the bleeding had stopped spontaneously and/or the risk of a subsequent colonoscopy was deemed too high in relation to the potential benefits.

  Up to 30 days after colorectal endoscopic polypectomy

Study Arms (2)

Colorectal polypectomy and prophylactic clipping before restarted anticoagulants

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

Device: Hemostatic clip

Colorectal polypectomy without prophylactic clipping before restarted anticoagulant

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

Interventions

Hemostatic clip DEVICE

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

Colorectal polypectomy and prophylactic clipping before restarted anticoagulants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults who have received an endoscopic colorectal polypectomy

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Helios Kliniken Schwerin: lead
• Medical School Hamburg: collaborator

Study Sites (1)

Helios Kliniken Schwerin

Schwerin, Mecklenburg-Vorpommern, 19055, Germany

RECRUITING

Related Publications (2)

• 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 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.

  PMID: 38670139 BACKGROUND

MeSH Terms

Conditions

Colonic Polyps; Polyps; Hemorrhage

Condition Hierarchy (Ancestors)

Intestinal Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Daniel Schmitz, Dr.med.

  Helios Kliniken Schwerin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Schmitz, Dr. med.

CONTACT

+493855202601; Daniel.Schmitz@helios-gesundheit.de

Martin Kliment

CONTACT

+493855202601; Martin.Kliment@helios-gesundheit.de

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head Physician

Study Record Dates

• First Submitted: May 28, 2025
• First Posted: June 6, 2025
• Study Start: May 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: June 18, 2025

Record last verified: 2025-06

Locations

DE (1)