E66.0
Conditions
Interventions
Group 1: Study group Sleeve gastrectomy using Disposable
Powered Articulating Endoscopic Linear Cutter Stapler &
Reloads technology with flat deck 50% of cases
Group 2: Study group Sleeve gastrectom
Sponsors
Rivolution GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Written informed consent - Age > 18 years - BMI Grad II (= 35(kg/m²) and Grad III (=40 kg/m²) - Patient considered for Sleeve Gastrectomy according to national and international guideline and according to the standards of the individual bariatric center - Patients with a BMI = 35 kg/m2 with one or more obesity-associated comorbidities such as type 2 diabetes mellitus, coronary heart disease, heart failure, hyperlipidemia, arterial hypertension, obstructive sleep apnea syndrome (OSAS), obesity hypoventilation syndrome, Pickwick syndrome, non-alcoholic Fatty liver disease (NAFLD) or non-alcoholic steaoto- hepatitis (NASH), pseudotumor cerebri, gastroesophageal reflux disease (GERD), asthma, chronic venous insufficiency, urinary incontinence, immobilizing joint disease, fertility impairment, or polycystic ovary syndrome, bariatric surgery - A primary indication in the sense of metabolic surgery can be made with a BMI = 40 kg/m² and coexisting type 2 diabetes mellitus if the improvement of the glycemic metabolism is more important than weight reduction as the treatment goal.
Exclusion criteria
Exclusion criteria: The following exclusion criteria will be considered: • Pregnancy, or the non-exclusion of pregnancy (for women of childbearing potential) * • Previous gastric surgery • Known Coagulopathy and/or Anticoagulation therapy • Esophageal Varices, • Liver cirrhosis • Lack of legal capacity • Vulnerable persons according to the law • Participating in another study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency and severity of intra- and postoperative bleeding and staple line leakage in both groups | — |
Secondary
| Measure | Time frame |
|---|---|
| - 5-point Likert-type scale for bleeding severity: 1: No bleeding [yes/no], 2: Minimal bleeding [yes/no], 3: Moderate bleeding [yes/no] 4: Excessive bleeding [yes/no], 5: Profuse bleeding [yes/no] - Usability ->> firing force, firing speed, general handling surgeon satisfaction - Number of FulGrip Reloads used in group SG - Number of Flat Deck Reloads used in group SG | — |
Countries
Germany
Contacts
Public ContactKarl Peter Rheinwalt
St. Franziskus-Hospital, Köln
Outcome results
None listed