Gastrostomy, Nissen Sleeve, Obesity, Roux-en-Y Gastric Bypass
Conditions
Brief summary
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.
Interventions
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.
Sponsors
Duomed
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of laparoscopic bariatric surgery using stapling devices (easyEndoTM Universal Linear Cutting Stapler and reloads - Ezisurg Medical) | At index procedure | Number of conversions, number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device performance | At index procedure | Number of procedures with technical success |
| Clinical efficacy - weight loss | Follow-up 1: 1 month after the procedure | Weight loss |
| Number of participants with a post-operative change of cormorbidities | Follow-up 3: 12 months after the procedure | 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. |
Countries
Belgium
Outcome results
None listed