Prevention of Post-Polypectomy Colorectal Bleeding by Clips in Patients on Anticoagulants
ConditionPolyp of Colon
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHelios Kliniken Schwerin
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
adult who has received a colonoscopy with endoscopic colorectal polypectomy
patient who has received at least one anticoagulant after polypectomy
Disqualifiers
Endoscopic polypectomy was combined with closure of the mucosal defect by a suturing device or full thickness resection device
Trial population
Adults who have received an endoscopic colorectal polypectomy
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Hemostatic clip
DeviceThe hemostatic clip is endoscopically applied after a colorectal polypectomy to close the mucosal defect.
Treatment groups
10,000 Participants
are divided into 2 treatment groupsGroup A: Colorectal polypectomy and prophylactic clipping before restarted anticoagulants1 intervention
Group B: Colorectal polypectomy without prophylactic clipping before restarted anticoagulant0 interventions
Trial outcomes
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.
Time frame
Up to 30 days after colorectal endoscopic polypectomySponsors and contacts
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Helios Kliniken Schwerin
Lead sponsor
Medical School Hamburg
Collaborator
Source ClinicalTrials.gov