Samer G Mattar, MD, Frank Bendewald, MD, Sarah Dutkevitch, RN OCN, Heather Kemp, MBA CCRP. Indiana University
Objective: The objectives of this clinical trial are to assess in a pilot, single center, prospective, non-randomized setting the overall performance and safety of the Endo GIA TM Reloads with Tri-StapleTM Technology & Endo GIA™ Ultra Universal Staplers (Covidien, North Haven, CT) when used in a gastric bypass procedure.
Methods and Procedures: Patients presenting for non-revisional RYGB with BMI<60 were approached for enrollment. Demographics and pre-operative labs were recorded. Patients underwent laparoscopic RYGB using Endo GIATM Ultra Universal Staplers and Endo GIATM Reloads with Tri-StapleTM Technology. OR time, length of stay, incidence of stapler malfunctions/misfires, incidence of serosal tearing at the staple line, incidence of intra-operative staple line bleeding requiring intervention, peri-operative and post-operative complications were recorded. Patients were assessed 1 month after surgery. As a single-arm pilot study, all results were summarized by descriptive statistics, including baseline patient characteristics, operative and post-operative data, and adverse events. Categorical variables were summarized as proportions for each category; continuous measures were summarized by mean and standard deviation or median and range as appropriate for the data distribution.
Results: Thirty patients, of whom 26 were women, were consented and enrolled. Twenty-six have completed surgery. Twenty-three have completed their 1 month visit. Pre-operative BMI averaged 44 (35-59). Post-operative BMI averaged 40 (31-55).One hundred-ninety-six Endo GIA™ Reloads with Tri-StapleTM Technology were used to date. A mix of 45 mm and 60 mm Tan and Purple reloads along with the Ultra Universal Stapler were used in all cases. All gastric bypass procedures were successful as defined by the uneventful creation of a functional staple line. A functional staple line in this study is defined by “B” shaped staples, normal firing forces, fully intact (complete or undisrupted) staple lines at each reloads’ initial firing. Operative time averaged 120 minutes (89-158 minutes). There was no evidence of serosal tearing in any of the 26 cases. Two malfunctions were reported (reload wouldn’t immediately open, reload wouldn’t fire) but did not affect patient safety or outcomes. Tan Endo GIATM Reloads with Tri-StapleTM Technology were used on mesentery in first eight cases. Blood loss amounts of 10-15cc and 50 cc were reported in two of the initial eight cases requiring intervention of cautery or clips. Subsequent cases were performed with Endo GIA RoticulatorTM 2.0mm grey vascular SULUs on the mesentery and blood loss amounts were reduced (less than 5cc in those cases). Complications reported were severe nausea (n=1), self-limited GI bleeding (n=1), and anastomotic stricture (n=1).
Conclusions: The Endo GIA TM Ultra Universal and Reloads with Tri-StapleTM Technology can be used safely and efficiently with a low complication rate for gastric pouch creation.
Program Number: P418