Observational
Conditions
Brief summary
The purpose of this observational study is to evaluate the safety and performance of the Endoscopic Linear Cutter Stapler and reloads from Fengh Medical used in laparoscopic Roux-en-Y gastric bypass surgery to create anastomoses. The goal of the study will be achieved by assessing the device performance and reporting of peri- and postoperative complications in a prospectively maintained database.
Interventions
DEVICEEndoscopic Linear Cutter Stapler and reloads
Endoscopic Linear Cutter Stapler and reloads
Sponsors
Duomed
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age at study entry is at least 18 years. * Patient must sign and date the informed consent form prior to the index-procedure. * Patient has a BMI ≥ 35 kg/m with one or more related co-morbidity. * Patient has a BMI ≥ 40 kg/m.
Exclusion criteria
* Patient is pregnant. * History of bariatric surgery. * Patient is known to be, or suspected of being unable to comply with the study protocol or proposed follow-up visits.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with adverse events related to the index-procedure. | 1 month follow-up | Determination of postoperative anastomotic leaks and intraluminal/intraperitoneal bleeding. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of adverse device effects. | 1, 6, 12 and 24 month follow-up | Determination of staple line disruption. |
| Number of patients with bariatric surgery related re-interventions. | 1, 6, 12 and 24 month follow-up | — |
| Percentage of excess weight loss. | 1, 6, 12 and month follow-up | pre-operative weight (kg) minus postoperative weight (kg) divided by the ideal body weight (kg). |
| Questionnaire on food tolerance. | 1, 6, 12 and 24 month follow-up | — |
Countries
Belgium
Outcome results
None listed