Prospective Case-Series of Ligasure Advance Pistol Grip and LigaSure Blunt Tip
The study is primarily to evaluate the safety and efficacy of the LigaSure Advance™ Pistol Grip and LigaSure™ Blunt Tip using the Force Triad™ Energy Platform during Roux-en-Y and gastric reduction procedures (sleeve gastrectomy or placation), respectively. Also, Economic value of using LigaSure in gastric surgeries will be appraised.
In this prospective case series, 60 patients previously scheduled to undergo a Roux-en-Y or gastric reduction procedure (sleeve gastrectomy or placation) will have hemostasis controlled with LigaSure Advance ™ Pistol Grip or LigaSure™ Blunt Tip, respectively. All subjects undergoing Roux-en-Y or gastric reduction procedures (sleeve gastrectomy or placation) procedure at Durham Regional Hospital will be recruited.
Data Analysis will be performed using the data collected in the software program titled MetaBar at Duke University Medical Center. Categorical variables will be summarized as proportions for each category; continuous measures will be summarized by mean and standard deviation or median and range as appropriated for the data distribution. Procedure-related risks are those typically associated with gastric procedures and general anesthesia including intra-operative bleeding, infection, and injury to surrounding organs and structures. Device related risks include those normally associated with the use of electrosurgery including intra-operative bleeding, unintended tissue burns, electrical shock, and electrical stimulation of muscles and nerves.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Prospective Case-Series of LigaSure Advance Pistol Grip and LigaSure Blunt Tip in Gastric Procedures|
- Safety and Efficacy of the LigaSure Advance Pistol Grip and LigaSure Blunt Tip using the Force Triad Energy Platform during Roux-en-Y and gastric reduction procedures. [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]Primary study variables include patient demographic information (age, pre- and post-operative BMI, gender, and presence of obesity associated co-morbid disease conditions such as hypertension, diabetes, sleep apnea, obesity hypoventilation, heart failure, prior blood clots, etc.), procedure time, American Society of Anesthesiologists (ASA) score, operative blood loss,length of hospital stay, and any complications noted up to one month post-operative.
- Economic value of using LigaSure in gastric surgeries [ Time Frame: 1 month ] [ Designated as safety issue: No ]These variables include the costs of the instrument, duration and costs of anesthesia, postoperative analgesic use, and hospital day rate costs to study the economic impact of different hemostatic devices and observe trends towards cost differences. Outcomes such as perceived ergonomics, multi-functionality, and access to organs will be collected.
|Study Start Date:||September 2011|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
|United States, North Carolina|
|Duke Center for Metabolic and Weightloss Surgery|
|Durham, North Carolina, United States, 27704|
|Principal Investigator:||Dana Portenier, MD||DUMC|