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The purpose of this observational registry is to evaluate the safety and performance of the easyEndoTM Universal Linear Cutting Stapler and reloads from Ezisurg Medical used in laparoscopic RYGB 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 |
|---|---|---|---|
| Obese patients eligible for laparoscopic RYGB surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) | Device | Device for creation of anastomoses during laparoscopic RYGB surgery manufactured by Ezisurg Medical. |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) | Number of participants with peri-operative anastomotic leaks and intraluminal/intraperitoneal bleeding. | at index-procedure |
| To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) | Number of participants with post-operative anastomotic leaks and intraluminal/intraperitoneal bleeding. | at discharge, up to 1 week |
| To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) | Number of participants with post-operative anastomotic leaks and intraluminal/intraperitoneal bleeding. | at 6 weeks follow-up |
| To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) | Number of participants with post-operative anastomotic leaks and intraluminal/intraperitoneal bleeding. | at 6 months follow-up |
| To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) | Number of participants with postoperative anastomotic leaks and intraluminal/intraperitoneal bleeding. | at 12 months follow-up |
| To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) | Number of participants with post-operative anastomotic leaks and intraluminal/intraperitoneal bleeding. | at 24 months follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the performance of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) | Number of procedures with technical success, defined as laparoscopic Roux-en-Y gastric bypass formation as intended without technical difficulties and without conversion to open laparotomy. | at index-procedure |
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Inclusion Criteria:
Exclusion Criteria:
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Obese patients eligible for laparoscopic RYGB surgery. This registry will collect data from 150 laparoscopic RYGB procedures in which anastomoses are created with the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AZ Sint-Jan Brugge | Bruges | West Flanders | 8000 | Belgium |
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| To evaluate the performance of the easyEndoTM Universal Linear Cutting |
Assessment of device performance (e.g. sharpness of the blade, staple-line formation, etc.). |
| at index-procedure |
| To evaluate the efficacy of the laparoscopic RYGB surgery | Number of participants with peri-operative complications such as but not limited to: peritonitis, anastomotic stenosis/stricture, internal hernia, small bowel obstruction, ulceration, fistula formation, ventral hernia, iatrogenic splenic injury, wound infection, pneumonia, pulmonary embolism, kidney failure, gallstones, arrhythmia, stroke, infarction, death. | at index-procedure |
| To evaluate the efficacy of the laparoscopic RYGB surgery | Number of participants with post-operative complications such as but not limited to: peritonitis, anastomotic stenosis/stricture, internal hernia, small bowel obstruction, ulceration, fistula formation, ventral hernia, iatrogenic splenic injury, wound infection, pneumonia, pulmonary embolism, kidney failure, gallstones, arrhythmia, stroke, infarction, death. | at discharge, up to 1 week |
| To evaluate the efficacy of the laparoscopic RYGB surgery | Number of participants with post-operative complications such as but not limited to: peritonitis, anastomotic stenosis/stricture, internal hernia, small bowel obstruction, ulceration, fistula formation, ventral hernia, iatrogenic splenic injury, wound infection, pneumonia, pulmonary embolism, kidney failure, gallstones, arrhythmia, stroke, infarction, death. | at 6 weeks follow-up |
| To evaluate the efficacy of the laparoscopic RYGB surgery | Number of participants with post-operative complications such as but not limited to: peritonitis, anastomotic stenosis/stricture, internal hernia, small bowel obstruction, ulceration, fistula formation, ventral hernia, iatrogenic splenic injury, wound infection, pneumonia, pulmonary embolism, kidney failure, gallstones, arrhythmia, stroke, infarction, death. | at 6 months follow-up |
| To evaluate the efficacy of the laparoscopic RYGB surgery | Number of participants with post-operative complications such as but not limited to: peritonitis, anastomotic stenosis/stricture, internal hernia, small bowel obstruction, ulceration, fistula formation, ventral hernia, iatrogenic splenic injury, wound infection, pneumonia, pulmonary embolism, kidney failure, gallstones, arrhythmia, stroke, infarction, death. | at 12 months follow-up |
| To evaluate the efficacy of the laparoscopic RYGB surgery | Number of participants with post-operative complications such as but not limited to: peritonitis, anastomotic stenosis/stricture, internal hernia, small bowel obstruction, ulceration, fistula formation, ventral hernia, iatrogenic splenic injury, wound infection, pneumonia, pulmonary embolism, kidney failure, gallstones, arrhythmia, stroke, infarction, death. | at 24 months follow-up |
| To evaluate the efficacy of the laparoscopic RYGB surgery | Number of participants with bariatric surgery related re-interventions since the laparoscopic RYGB procedure. | at discharge, up to 1 week |
| To evaluate the efficacy of the laparoscopic RYGB surgery | Number of participants with bariatric surgery related re-interventions since the laparoscopic RYGB procedure. | at 6 weeks follow-up |
| To evaluate the efficacy of the laparoscopic RYGB surgery | Number of participants with bariatric surgery related re-interventions since the laparoscopic RYGB procedure. | at 6 months follow-up |
| To evaluate the efficacy of the laparoscopic RYGB surgery | Number of participants with bariatric surgery related re-interventions since the laparoscopic RYGB procedure. | at 12 months follow-up |
| To evaluate the efficacy of the laparoscopic RYGB surgery | Number of participants with bariatric surgery related re-interventions since the laparoscopic RYGB procedure. | at 24 months follow-up |
| To evaluate the efficacy of the laparoscopic RYGB surgery | Change of patient's weight | at 6 weeks follow-up |
| To evaluate the efficacy of the laparoscopic RYGB surgery | Change of patient's weight | at 6 months follow-up |
| To evaluate the efficacy of the laparoscopic RYGB surgery | Change of patient's weight | at 12 months follow-up |
| To evaluate the efficacy of the laparoscopic RYGB surgery | Change of patient's weight | at 24 months follow-up |
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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