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Post-marketing, observational study to evaluate the safety and performance of the ALTUS Powered Stapler in bariatric surgery of "real-world" patients.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treated patients | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stapler | Device | Stapling performed with ALTUS Powered Stapler |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Adults (18 years or older), who underwent bariatric surgery with the use of Altus Powered Stapler
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital IGESP | São Paulo | São Paulo | 01331010 | Brazil |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D013528 | Surgical Staplers |
| ID | Term |
|---|---|
| D013525 | Surgical Instruments |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |