Observational Study of ALTUS Powered Stapler Used in Bariatric Surgery
- Conditions
- Obesity
- Registration Number
- NCT05642663
- Lead Sponsor
- Scitech Produtos Medicos Ltda
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 300
Inclusion Criteria:<br><br> - Patients with grade II obesity (BMI = 35 kg/m^2) with one or more associated<br> comorbidities;<br><br> - Patients with grade III obesity (BMI = 40 kg/m^2) regardless of associated diseases;<br><br> - Patients who underwent sleeve, bypass and revisional bariatric surgery procedure<br> with use of the Altus Powered Stapler;<br><br> - The patient must sign and date the informed consent form during a routine follow-up<br> visit, authorizing the use of their surgery data and contact for follow-up.<br><br>Exclusion Criteria:<br><br> - Impossibility of collecting data related to the surgical procedure<br><br> - Impossibility of contact with the patient to obtain the informed consent form
Not provided
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety - Conversion to open surgery;Safety - Number of reinterventions;Safety - Postoperative anastomotic leaking and intraluminal/intraperitoneal bleeding;Safety- Fistula formation;Safety - Stenosis;Performance - Procedure Success;Performance - Cicatrization of staple line
- Secondary Outcome Measures
Name Time Method Post-operative change in weight