Obesity
Conditions
Keywords
Stapler, ALTUS, Bariatric surgery
Brief summary
Post-marketing, observational study to evaluate the safety and performance of the ALTUS Powered Stapler in bariatric surgery of real-world patients.
Detailed description
Up to 300 patients who underwent sleeve, bypass or revisional bariatric surgery with the use of Altus Powered Stapler will be included in the study. The stapler should be used according to the Instructions for Use and according to the local practice. The Altus Powered Stapler is used in open or laparoscopic surgeries and simultaneously cuts and staples soft tissues. In order to avoid great physical efforts by the physician and ensure excellent tissue suturing, the cutting and stapling mechanism is driven by the 12-volt battery that comes with the stapler. Patients will be followed by 7, 30 and 90 days and 12 months after the procedure, as per the research center's standard routine.
Interventions
DEVICEStapler
Stapling performed with ALTUS Powered Stapler
Sponsors
Scitech Produtos Medicos Ltda
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with grade II obesity (BMI ≥ 35 kg/m\^2) with one or more associated comorbidities; * Patients with grade III obesity (BMI ≥ 40 kg/m\^2) regardless of associated diseases; * Patients who underwent sleeve, bypass and revisional bariatric surgery procedure with use of the Altus Powered Stapler; * The patient must sign and date the informed consent form during a routine follow-up visit, authorizing the use of their surgery data and contact for follow-up.
Exclusion criteria
* Impossibility of collecting data related to the surgical procedure * Impossibility of contact with the patient to obtain the informed consent form
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Performance - Cicatrization of staple line | 90 days | The absence of oozing/bleeding at the staple line |
| Safety - Conversion to open surgery | Intraoperative | Number of conversions to open surgery during the index procedure |
| Safety - Number of reinterventions | Up to 1 week | Number of reinterventions within 1 week after the procedure |
| Safety - Postoperative anastomotic leaking and intraluminal/intraperitoneal bleeding | 30 days | Presence of complications of anastomotic leaking and intraluminal/intraperitoneal bleeding within 30 days after procedure |
| Safety- Fistula formation | 30 days | Presence of fistula within 30 days after procedure |
| Safety - Stenosis | 90 days | Detection of stenosis within 90 days after procedure |
| Performance - Procedure Success | Intraoperative | Defined by completion of technique with the device for its intended use |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative change in weight | 12 months | Defined by preoperative weight (kg) minus postoperative weight (kg) divided by ideal body weight (kg) at the end of 12 months. |
Countries
Brazil
Outcome results
None listed