A Registry of Laparoscopic Bariatric Surgery Using Stapling Devices: Observation of Safety and Clinical Efficacy

Study Overview
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Brief Summary
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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.

Official Title
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A Multicentric Prospective Registry of Laparoscopic Bariatric Surgery Using Stapling Devices: Observation of Safety and Clinical Efficacy

Conditions
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Obesity, Roux-en-Y Gastric Bypass, Gastrostomy, Nissen Sleeve

Intervention / Treatment
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* Device: easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient ≥ 18 years of age at registry entry Patient and investigator signed and dated the informed consent form prior to the index-procedure. Patient has a BMI ≥ 35 kg/m2, with one or more related co-morbidities. Patient has a BMI ≥ 40 kg/m2. Patient is eligible for laparoscopic bariatric surgery. Exclusion Criteria: Patient is unable/unwilling to provide informed consent. Patient has a history of bariatric surgery. Patient is unable to comply with the registry protocol or the proposed follow-up visits. Patient has a contra-indication for laparoscopic bariatric surgery.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Obese patients eligible for laparoscopic bariatric surgery<br> | Device: easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo. | Follow-up 4: 24 months after the procedure | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |