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| Name | Class |
|---|---|
| University Hospital, Montpellier | OTHER |
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The Nissen Sleeve technique consists of creating a gastric total fundoplication (Nissen technique) before to perform the removal of 2/3 of the stomach (SLEEVE technique), intends for decrease the rate of gastroesophageal reflux disease (GERD). This study aims to evaluate the influence of the Nissen Sleeve technique on GERD. However, the Ezisurg easyEndoTM Linear Cutting Stapler and Loading Units for Single Use were used in this study, and its safety and performance could be evaluated at the same time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ezisurg stapler | Experimental | easyEndoTM Lite Linear Cutting Stapler (U12L60) and Loading Units (N60G) manufactured by Ezisurg |
|
| Ethicon Stapler | Active Comparator | ECHELONâ„¢ Powered Stapler and reload (GST60G) manufactured by Johnson & Johnson. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ezisurg stapler SLEEVE technique | Procedure | The Nissen Sleeve technique consists of creating a gastric total fundoplication (Nissen technique) before to perform the removal of 2/3 of the stomach (SLEEVE technique) |
| Measure | Description | Time Frame |
|---|---|---|
| The rate of patients with GERD at 24 months | The main objective of the study was to evaluate the impact of Sleeve Gastrectomy procedure with a Nissen fundoplication (Nissen-Sleeve) on the rate of patients with GERD at 24 months. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Surgery time | Perioperative/Periprocedural | |
| Intra-operation incidents | Perioperative/Periprocedural | |
| Hospital stays |
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Inclusion Criteria
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Français du Levant | Montpellier | Hérault | 34295 | France |
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| Ethicon Stapler SLEEVE technique | Procedure | The Nissen Sleeve technique consists of creating a gastric total fundoplication (Nissen technique) before to perform the removal of 2/3 of the stomach (SLEEVE technique) |
|
| Perioperative/Periprocedural |
| Rate of re-intervention | two-year |
| Rate of re-hospital | two-year |
| One-year Endoscopy finding | One-year |
| Early & Long term post-operative complication | two-year |
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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