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The purpose of this observational registry is to evaluate the safety and the clinical efficacy of laparoscopic bariatric surgery using stapling devices (easyEndoTM Universal Linear Cutting Stapler and reloads from Ezisurg Medical). The goal of the study will be achieved by reporting peri- and postoperative complications and the clinical outcome after surgery in a prospectively maintained database.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Obese patients eligible for laparoscopic bariatric surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) | Device | Investigational device: easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical). Device for the creation of anastomoses during laparoscopic bariatric surgery manufactured by Ezisurg Medical. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of laparoscopic bariatric surgery using stapling devices (easyEndoTM Universal Linear Cutting Stapler and reloads - Ezisurg Medical) | Number of conversions, number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo. | At index procedure |
| Safety of laparoscopic bariatric surgery using stapling devices (easyEndoTM Universal Linear Cutting Stapler and reloads - Ezisurg Medical) | Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo. | At discharge up to 1 week |
| Safety of laparoscopic bariatric surgery using stapling devices (easyEndoTM Universal Linear Cutting Stapler and reloads - Ezisurg Medical) | Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo. | Follow-up 1: 1 month after the procedure |
| Safety of laparoscopic bariatric surgery using stapling devices (easyEndoTM Universal Linear Cutting Stapler and reloads - Ezisurg Medical) | Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo. | Follow-up 2: 6 months after the procedure |
| Safety of laparoscopic bariatric surgery using stapling devices (easyEndoTM Universal Linear Cutting Stapler and reloads - Ezisurg Medical) | Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo. | Follow-up 3: 12 months after the procedure |
| Safety of laparoscopic bariatric surgery using stapling devices (easyEndoTM Universal Linear Cutting Stapler and reloads - Ezisurg Medical) |
| Measure | Description | Time Frame |
|---|---|---|
| Device performance | Number of procedures with technical success | At index procedure |
| Device performance | Scoring of: easy of intra-abdominal device positioning, grasping/climbing force, sharpness of the blades, staple-line formation, device stability, device maneuverability, device consistency and reliability, ergonomic design, hemostasis. Each of the aforementioned items receives a score from 0 to 4, with 0 indicating that the user is very unsatisfied and 4 indicating that the user is very satisfied. |
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Inclusion Criteria:
Exclusion Criteria:
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Obese patients eligible for laparoscopic bariatric surgery. This registry will collect data from 250 laparoscopic bariatric procedures in which anastomoses are created with the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical).
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| Name | Affiliation | Role |
|---|---|---|
| Salvatore Lobue, MD | Hôpital de Nivelles (groupe Jolimont), Haine-Saint-Paul, Belgium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ziekenhuis Oost-Limburg, campus St.-Jan | Genk | Belgium | ||||
| Hôpital de Nivelles, groupe Jolimont |
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|
Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo. |
| Follow-up 4: 24 months after the procedure |
| At index procedure |
| Clinical efficacy - weight loss | Weight loss | Follow-up 1: 1 month after the procedure |
| Clinical efficacy - weight loss | Weight loss | Follow-up 2: 6 months after the procedure |
| Clinical efficacy - weight loss | Weight loss | Follow-up 3: 12 months after the procedure |
| Clinical efficacy - weight loss | Weight loss | Follow-up 4: 24 months after the procedure |
| Number of participants with a post-operative change of cormorbidities | Comorbidities (diabetes mellitus, peripheral arterial disease, coronary arterial disease, sleep disordered breathing, hypertension, dyslipidemia, hypercholesterolemia, hypertriglyceridemia, asthma, congestive heart failure, degenerative joint disease, gastroesophageal reflux, chronic obstructive pulmonary disease, use of immunosuppressants) 12 months after the surgical procedure as compared to the patients' comorbidities at baseline. | Follow-up 3: 12 months after the procedure |
| Number of participants with a post-operative change of cormorbidities | Comorbidities (diabetes mellitus, peripheral arterial disease, coronary arterial disease, sleep disordered breathing, hypertension, dyslipidemia, hypercholesterolemia, hypertriglyceridemia, asthma, congestive heart failure, degenerative joint disease, gastroesophageal reflux, chronic obstructive pulmonary disease, use of immunosuppressants) 24 months after the surgical procedure as compared to the patients' comorbidities at baseline. | Follow-up 4: 24 months after the procedure |
| Haine-Saint-Paul |
| Belgium |
| Ziekenhuis Maas en Kempen | Maaseik | Belgium |
| 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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