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| Name | Class |
|---|---|
| University of Sao Paulo | OTHER |
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Randomized, comparative and prospective study between Conventional Endoscopic Mucosal Resection for the removal of flat or sessile colorectal lesions without previous attempt to resection.
This prospective randomized trial was conducted in 2 academic services: Instituto do Câncer do Estado de São Paulo and Centro de Diagnóstico em Gastroenterologia, both linked to the University of São Paulo. The clinical study was performed in accordance to the Declaration of Helsinki.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Mucosal Resection | Active Comparator | C-EMR will be made with saline injection with the indigo carmine. |
|
| Underwater Mucosal Resection | Experimental | UW-EMR will be made after the complete filling of lumen with water. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional Endoscopic Mucosal Resection | Procedure | Conventional Endoscopic Mucosal Resection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Technical success rate | three years | |
| Safety (incidence of complications); | three years | |
| Local recurrence. | Four years |
| Measure | Description | Time Frame |
|---|---|---|
| Resection rate en bloc | three years | |
| Time of resection | Three years | |
| Sydney resection ratio (characterized by the following equation - lesion size in millimeters |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luciano Lenz, PhD | Cancer Institute of the state of São Paulo (ICESP) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto do Cancer do Estado de Sao Paulo | São Paulo | 01246-000 | Brazil |
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| Underwater Endoscopic Mucosal Resection | Procedure | Underwater Endoscopic Mucosal Resection |
|
|
| Three years |
| ID | Term |
|---|---|
| D000236 | Adenoma |
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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