An observational study in Polyp of Colon, sponsored by Helios Kliniken Schwerin. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-18.
Sponsored by Helios Kliniken Schwerin · Observational
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.
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).
377 studies on the registry are indexed under Colonic Polyps; 57 are open to participants now.
This study's planned enrollment of 10,000 is above the median of 411 across 115 observational studies indexed under Colonic Polyps.
Browse Colonic Polyps studies →Helios Kliniken Schwerin is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adults who have received an endoscopic colorectal polypectomy
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
At least one prophylactic clip is applied to close the mucosal defect after polypectomy
Device: Hemostatic clip
A prophylactic clip is not applied to close the mucosal defect after polypectomy.
The hemostatic clip is endoscopically applied after a colorectal polypectomy to close the mucosal defect.
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.
Time frame: Up to 30 days after colorectal endoscopic polypectomy
Started May 2025 (actual). Primary completion is estimated for May 2026, 12 months after the start.
Of 52 non-industry observational studies under Colonic Polyps, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 90. This study's planned 12 months is below that.
Counting every sponsor, half of 62 studies reached it within 19 months; a quarter within 10 and three quarters within 90.
How these figures are worked out, and which studies are left out of them.
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Helios Kliniken Schwerin