Observational Study of ALTUS Powered Stapler Used in Bariatric Surgery

Study Overview
=================
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.

Official Title
-----------------
Post-marketing, Observational Study of ALTUS Powered Stapler Used in Bariatric Surgery

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Device: Stapler


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Treated patients<br>Patients with grade II (with one or more associated comorbidities) and grade III obesity who went through sleeve, bypass and revisional bariatric surgery procedure with the use of Altus Powered Stapler | Device: Stapler<br>* Stapling performed with ALTUS Powered Stapler<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety - Conversion to open surgery | Number of conversions to open surgery during the index procedure | Intraoperative | 
| Safety - Number of reinterventions | Number of reinterventions within 1 week after the procedure | Up to 1 week | 
| Safety - Postoperative anastomotic leaking and intraluminal/intraperitoneal bleeding | Presence of complications of anastomotic leaking and intraluminal/intraperitoneal bleeding within 30 days after procedure | 30 days | 
| Safety- Fistula formation | Presence of fistula within 30 days after procedure | 30 days | 
| Safety - Stenosis | Detection of stenosis within 90 days after procedure | 90 days | 
| Performance - Procedure Success | Defined by completion of technique with the device for its intended use | Intraoperative | 
| Performance - Cicatrization of staple line | The absence of oozing/bleeding at the staple line | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative change in weight | Defined by preoperative weight (kg) minus postoperative weight (kg) divided by ideal body weight (kg) at the end of 12 months. | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stapler, ALTUS, Bariatric surgery