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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07007598
Acronym
PiCAnt
Enrollment
10000
Registered
2025-06-06
Start date
2025-05-01
Completion date
2026-11-01
Last updated
2025-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polyp of Colon

Keywords

polyps, Hemorrhage, Anticoagulants

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).

Interventions

DEVICEHemostatic clip

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

Sponsors

Medical School Hamburg
CollaboratorOTHER
Helios Kliniken Schwerin
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Colorectal Post-polypectomy bleedingUp to 30 days after colorectal endoscopic polypectomyMucosal 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.

Countries

Germany

Contacts

Primary ContactDaniel Schmitz, Dr. med.
Daniel.Schmitz@helios-gesundheit.de+493855202601
Backup ContactMartin Kliment
Martin.Kliment@helios-gesundheit.de+493855202601

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026