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NCT Number: NCT07007598

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

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.

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Key information

Conditions

Polyp of Colon Colonic Polyps Hemorrhage Intestinal Polyps Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hemostatic clip

Device

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

Primary outcomes

  1. Colorectal Post-polypectomy bleeding

    Time frame: Up to 30 days after colorectal endoscopic polypectomy

    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:

    • Polypectomy bleeding is visualized directly during a subsequent colonoscopy.
    • 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.
    • 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Daniel Schmitz, Dr. med.

CONTACT

[email protected]

+493855202601

Martin Kliment

CONTACT

[email protected]

+493855202601

Sponsors and collaborators

Lead sponsor

Helios Kliniken Schwerin

Other

Collaborators

  • Medical School Hamburg

Registry information

Official study title

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

Acronym: PiCAnt

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 6, 2025
Registry last updated
Jun 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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