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Gastrointestinal bleeding is defined as clinical evidence of bleeding manifested by melena, hematochezia that required endoscopic hemostasis. GI bleeding associated to endoscopic procedure is defined as clinical evidence of bleeding and a drop in hemoglobin of ≥ 2g/dL on the day of the procedure (early bleeding) or up to 14 days after the procedure (delayed bleeding).GI bleeding is, nevertheless, a common complication of endoscopic procedures, such as endoscopic mucosal resection (EMR) and endoscopic sub mucosal dissection (ESD). For example, colorectal ESD, which is technically more difficult than gastric or esophageal ESD because of the anatomical features of the colon, present an increased risk of delayed bleeding. According to literature, early bleeding occurs on average in 5,3% of endoscopic resections of the whole digestive tract, with bleeding rates per location as follows: esophagus 9.4%, stomach 9.1%, duodenum 3.6%, colon 3.4%. Concerning delayed bleeding, it is assessed to complicate 3.1% of endoscopic resection procedures. The bleeding rate in the duodenum is usually the highest (6.3%), followed by colon at (3.6%), stomach (1.5%) and esophagus (0.9%). Age, lesion size and piecemeal resection are associated with an increased risk of bleeding. Usage of aspirin or NSAIDs seems to not increase risk of post-polypectomy bleeding, while clopidogrel and warfarin do and should be discontinued in the periprocedural period to prevent the occurrence of post-polypectomy bleeding. Direct oral anticoagulants (DOAC) administration shows similar post-procedural gastrointestinal bleeding risk to anti-vitamin K antagonists (VKA) administration in patients undergoing endoscopic procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HaemoCer-PLUS | Patients who had receive HaemoCer-PLUS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HaemoCer-PLUS | Device | HaemoCer-PLUS |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number and proportion of bleeding events in patients receiving HaemoCer-PLUS | Number and proportion of bleeding events controlled by application of HaemoCer | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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This will be a multicenter and observational registry of patients treated with HaemoCer- PLUS to obtain hemostasis.
All centres participating in the project will select the patients according to the in- and exclusion criteria. Ethical approval will be obtained in every participant hospital. All patients entering this new registry will have to sign a patient inform consent.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Benedetto Mangiavillano, MD | Contact | 00390331476381 | benedetto.mangiavillano@materdomini.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Humanitas-Mater Domini | Castellanza | 21053 | Italy |
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