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This prospective observational study aims to evaluate the efficacy, safety and recurrence of cold-snaring for large colonic lesions combined with argon plasma coagulation of the resection bed.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Procedure: Cold EMR + APC | Procedure |
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| Measure | Description | Time Frame |
|---|---|---|
| Residual | Evaluation of residual in the biopsy of the defect after the cold-EMR. The specimen will be evaluated independently from the polyp sample. | 1 day |
| Recurrence | The recurrence rate of adenomas at the site of any qualifying, previously resected lesions is measured after 3-6 and 12 months. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of procedure | Complete resection of polyp | 1 day |
| Rate of delayed bleeding of the patient | Delayed-bleeding, defined was defined as clinical evidence of bleeding (hematemesis, hematochezia or melena or a decrease of hemoglobin concentration > 2g/dL, which required transfusion or endoscopic reintervention with hemostasis within 30 days of hospital discharge) |
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Inclusion Criteria:
Exclusion Criteria:
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All subjects will be evaluated for post-procedural pain (using a VAS scale) and need for pain-killers. As part of the standard care, the patient will receive a 30-day post procedure follow-up phone call or an ambulatory evaluation will be arranged 30-days after the endoscopic procedure, to discuss the histologic results and schedule a standard follow-up colonoscopy procedure after the initial procedure. The investigators will measure the post procedural pain in the first four weeks after treatment, the need for pain-killers and, should these occur, the adverse events (included fever, hematochezia, need for hospital admission). The rate of recurrence will be calculated by endoscopic visualization of the EMR site at the follow-up (T1:3-6 months; T2 11-13Months) using endoscopic magnification and electronic chromoendoscopy.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Endoscopy Unit, Gastroenterology Department, Humanitas Research Hospital | Rozzano | Milano | 20089 | Italy |
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| ID | Term |
|---|---|
| D003108 | Colonic Diseases |
| ID | Term |
|---|---|
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| 1 day |
| Rate of post-polipectomy syndrome | The post-polipectomy syndrome is defined by the presence of fever or abdominal pain | 1 day |
| perforation | Rate of perforation and delayed perforation | 1 day |
| Time | Average time of procedure and polyp resection time | 1 day |