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.
Study Type
OBSERVATIONAL
Enrollment
100
Endoscopic Linear Cutter Stapler and reloads
Ziekenhuis Oost-Limburg
Genk, Limburg, Belgium
Number of patients with adverse events related to the index-procedure.
Determination of postoperative anastomotic leaks and intraluminal/intraperitoneal bleeding.
Time frame: 1 month follow-up
Number of patients with adverse events related to the index-procedure.
Determination of postoperative anastomotic leaks and intraluminal/intraperitoneal bleeding.
Time frame: 6 months follow-up
Number of adverse device effects.
Determination of staple line disruption.
Time frame: 1, 6, 12 and 24 month follow-up
Number of patients with bariatric surgery related re-interventions.
Time frame: 1, 6, 12 and 24 month follow-up
Percentage of excess weight loss.
pre-operative weight (kg) minus postoperative weight (kg) divided by the ideal body weight (kg).
Time frame: 1, 6, 12 and month follow-up
Questionnaire on food tolerance.
Time frame: 1, 6, 12 and 24 month follow-up
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