Marisha L Godek, PhD, MS, Elizabeth Contini, Andrew Miesse, MS, Patrick Mozdzierz, Michael Soltz, PhD, Dwight G Bronson, MS. Covidien Surgical Solutions.
Objective: The purpose of this investigation was to evaluate a novel three row variable height circular surgical stapler in sites with similar (colocolonic) and non-similar (gastrojejunic) thicknesses of apposed tissue and to allow interrogation of early anastomotic healing events in these locations.
Description: In each canine subject one gastrojejunostomy and two colocolostomies were made utilizing a novel three row variable height circular stapler or a control DST Series™ EEA™. Subjects were evaluated at post-operative days 3, 10, 21 and 28 using select complementary interrogative methods including radiography, endoscopy, gross observations upon necropsy, tissue imaging/measurement and histopathology. Each anastomotic site was excised post-mortem, and an anastomotic index was calculated; staple formation was also analyzed. Subject weight loss was also closely tracked post-operatively.
Preliminary Results: All animals survived the surgeries with no adverse events, and post-operative percent weight loss ranged from 0-13.8 %. Radiography provided insight to the location and number of staples in each staple line in real time. Fluoroscopy was beneficial when used in combination with the endoscope to aid in the location of the staple lines. Endoscopy allowed stoma visualization, verification of stoma patency in the stomach and real time assessment of tissue health and healing. Anastomotic index calculations revealed similar results for both devices; notably, the novel device showed less relative contraction in the staple lines placed in the colon by Day 28. Histopathology results indicated adequate to excellent healing responses over the same time frame.
Conclusions: Based on the series of in vivo and post-mortem evaluation criteria presented here, the novel three row variable height yielded results comparable to the gold standard “control” DST Series™ EEA™ device in this model, which assessed tissue apposition at anastomoses with equivalent and non-equivalent tissue thicknesses.
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