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.
Study Type
OBSERVATIONAL
Enrollment
150
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.
Ziekenhuis Oost-Limburg, campus St.-Jan
Genk, Belgium
Hôpital de Nivelles, groupe Jolimont
Haine-Saint-Paul, Belgium
Ziekenhuis Maas en Kempen
Maaseik, Belgium
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Follow-up 4: 24 months after the procedure
Device performance
Number of procedures with technical success
Time frame: 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.
Time frame: At index procedure
Clinical efficacy - weight loss
Weight loss
Time frame: Follow-up 1: 1 month after the procedure
Clinical efficacy - weight loss
Weight loss
Time frame: Follow-up 2: 6 months after the procedure
Clinical efficacy - weight loss
Weight loss
Time frame: Follow-up 3: 12 months after the procedure
Clinical efficacy - weight loss
Weight loss
Time frame: 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.
Time frame: Follow-up 3: 12 months after the procedure
Number of participants with a post-operative change of cormorbidities
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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.
Time frame: Follow-up 4: 24 months after the procedure