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The purpose of this observational study is to evaluate the safety and performance of the Endoscopic Linear Cutter Stapler and reloads from Fengh Medical used in laparoscopic Roux-en-Y gastric bypass surgery to create anastomoses. The goal of the study will be achieved by assessing the device performance and reporting of peri- and postoperative complications in a prospectively maintained database.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RYGB surgery | Obese patients eligible for laparoscopic Roux-en-Y gastric bypass (RYGB) surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic Linear Cutter Stapler and reloads | Device | Endoscopic Linear Cutter Stapler and reloads |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with adverse events related to the index-procedure. | Determination of postoperative anastomotic leaks and intraluminal/intraperitoneal bleeding. | 1 month follow-up |
| Number of patients with adverse events related to the index-procedure. | Determination of postoperative anastomotic leaks and intraluminal/intraperitoneal bleeding. | 6 months follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse device effects. | Determination of staple line disruption. | 1, 6, 12 and 24 month follow-up |
| Number of patients with bariatric surgery related re-interventions. | 1, 6, 12 and 24 month follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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Obese patients eligible for laparoscopic Roux-en-Y gastric bypass surgery.
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| Name | Affiliation | Role |
|---|---|---|
| Hans Verhelst, Dr. | ZOL, Genk | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ziekenhuis Oost-Limburg | Genk | Limburg | 3600 | Belgium |
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| Percentage of excess weight loss. | pre-operative weight (kg) minus postoperative weight (kg) divided by the ideal body weight (kg). | 1, 6, 12 and month follow-up |
| Questionnaire on food tolerance. | 1, 6, 12 and 24 month follow-up |