Prospective, multi-center study will evaluate a pulsing technique with the ECHELON FLEX GST system for hemostasis at the staple line in laparoscopic sleeve gastrectomy procedures.
Prospective, multi-center study will evaluate a pulsing technique with the ECHELON FLEX GST system for hemostasis at the staple line in laparoscopic sleeve gastrectomy procedures. Data collected for the study consists of videography imaging and audio. Video recordings (no subject identifiers) will involve the use of two cameras providing: 1. Synchronized Internal and external views of devices used, including the hands of the surgeon firing the endocutter; and 2. Audio of the procedure to record the motor noise of the device while firing (audio will help identify the surgeon's pulsing technique during the procedure). Surgeon satisfaction with transection technique will also be collected. Videography will be evaluated for staple line hemostasis and need for surgical intervention at the staple line (defined in Criteria for Evaluation).
Study Type
OBSERVATIONAL
Enrollment
62
Laparoscopic sleeve procedures with powered stapler
Surgical Specialists of Louisiana
Metairie, Louisiana, United States
State University of New York at Buffalo
Buffalo, New York, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Occurrence of oozing/bleeding at the staple line
Investigate whether use of a prescribed pulsing technique may provide potential reduction in the occurrence of oozing/bleeding at the staple line.
Time frame: Intraoperative
Occurence of sugical interventions required to achieve hemostasis at the staple line
Investigate whether use of a prescribed pulsing technique may provide potential reduction in the occurrence of surgical interventions required to achieve hemostasis at the staple line.
Time frame: Intraoperative
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