Page 67 - World Journal of Laparoscopic Surgery

ORIGINAL RESEARCH
Medtronic I-Drive vs Ethicon Echelon: A Head-to-head

Randomized Controlled Trial

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Chelsey McKinnon , Ryan Yang , Cara Reitz , Aaron Lane , Daniel Roubik , John P Schriver , Eric P Ahnfeldt 7
AbstrAct
The views expressed in this publication/presentation are those of the author(s) and do not reflect the official policy or position of William
Beaumont Army Medical Center, Department of the Army, Defense Health Agency, or the US Government.
Background: There have been numerous studies comparing various aspects of bariatric surgery, such as hand sewn vs stapled anastomoses,
electronic vs manual staplers, and reinforced vs nonreinforced staple lines. There has never been a randomized controlled trial comparing
different staplers in sleeve gastrectomies.
Methods: Our study was a randomized control trial comparing the staple reload time, complications, and stapler cost for the Medtronic I-Drive
and the Ethicon Echelon. Our primary endpoints were time, hemostasis, bleeding, necessity for transfusion, and leak rate in a military system.
Results: Sixty-three patients were consented for the study with a final number of 26 in the Echelon arm and 25 in the I-Drive arm after fallout.
There were a total of 140 stapler reloads in the Echelon arm and 123 in the I-Drive arm. The median staple reload times were 39.78 seconds
for the I-Drive and 41.77 seconds for the Echelon (p = 0.42). The total time for sleeve creation was 12.14 minutes in the Echelon arm and
14.26 minutes in the I-Drive arm (p = 0.04). There were two misfires in each group (four total) and no positive leak tests, transfusions, or
postoperative complications. The average cost for staplers, reloads, and reinforcement for the I-Drive was $2,037.26 for the civilian rate and
$2,097.66 for the government rate. The average cost for the Echelon was $1,835.65 for the civilian rate and $2,268.97 for the government rate.
Conclusion: The Medtronic I-Drive and the Ethicon Echelon are comparable in reload time, stapler misfires, leak test rates, and cost.
WBAMC IRB Study Trial Number: NCT02731079.
Keywords: Bariatric surgery, Linear stapler, Minimally invasive surgery.
World Journal of Laparoscopic Surgery (2022): 10.5005/jp-journals-10033-1498

IntroductIon 1–7 Department of General Surgery, William Beaumont Army Medical
Obesity rates in the United States continue to rise and with the Center, El Paso, Texas, United States of America
CDC reporting the prevalence rate of obesity in adults at 42.4% Corresponding Author: Ryan Yang, Department of General Surgery,
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as of 2018. The rate of bariatric surgeries in the United States has William Beaumont Army Medical Center, El Paso, Texas, United States
risen in a concomitant fashion. The total number almost doubled of America, Phone: +(847) 481 9370, e-mail: ryan.c.yang.mil@mail.mil
between 2011 and 2018 with 252,000 bariatric surgeries performed How to cite this article: McKinnon C, Yang R, Reitz C, et al. Medtronic
in 2018 and sleeve gastrectomies representing the predominant I-Drive vs Ethicon Echelon: A Head-to-head Randomized Controlled
growth at 61.4% of bariatric interventions. 2 Trial. World J Lap Surg 2022;15(1):65–68.
In the late 1980s, Dr Doug Hess developed the sleeve gastrectomy Source of support: Nil
as an alternative to the vertical gastrectomy, which imparted a Conflict of interest: None
restrictive function to the biliopancreatic diversion. 3–5 Addition of
a gastrectomy to the biliopancreatic diversion also allowed for a
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reduction in the length of bowel bypassed without compromising reinforcement material, and placing biological sealant. There is a
weight loss results and preservation of the pylorus aids in general consensus that any staple line reinforcement is superior in
decreasing complications like dumping. 6–8 In the early 2000s, sleeve preventing leaks compared to no reinforcement, but evidence for a
gastrectomies developed into a shorter, safer initial operation for the superior type of reinforcement remains controversial. 18–20
super morbidly obese population in preparation for a more extensive With a rising popularity in sleeve gastrectomies among
operation, such as the Roux-en-Y gastric bypass or the biliopancreatic bariatric surgeons and patients, comprehensively researching
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diversion. However, in recent years, sleeve gastrectomies have all aspects of the operation is critical for optimizing patient
established their role as a safe, single-stage operation. 10 outcomes. There have been many studies evaluating the safety
The most significant early postoperative complication is and efficacy of sleeve gastrectomies, but to our knowledge,
bleeding from the long staple line with reported rates as high as there is a paucity of data available for head-to-head analyzes of
16% with an average of 3.6%. 11–13 Another serious complication is the the time and cost differential between competing linear stapler
development of a gastric leak with reported incidences as high as devices with an absorbable polymer membrane reinforcement.
3.7%, which are more commonly found at the proximal anastomosis We sought to compare the Ethicon Echelon Flex with Seamguard
compared to the distal. 14–16 Various proposed modalities for bioabsorbable reinforcement (W.L. Gore & Associates, Inc.) with
decreasing the rates of these complications include oversewing the Covidien Endo GIA reinforced reload with tri-staple technology
the staple line, buttressing the staple line with organic or synthetic (Medtronic, Minneapolis, Minnesota, USA).

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