Safety and Feasibility of a Lower-Cost Stapler in Bariatric Surgery
Kurt E Roberts1, L Renee Hilton1,2, Danielle T Friedman3
1Department of Surgery, Gastrointestinal Section, Yale University, 40 Temple Street, Suite 7B, New Haven, CT, 06510, USA.
Background:
Laparoscopic staplers are integral to bariatric surgery. Their pricing significantly impacts the overall cost of procedures. An independent device company has designed a stapler handle and single-use reloads for cross-compatibility and equivalency with existing manufacturers, at a lower cost.
Objectives:
We aim to demonstrate non-inferior function and cross-compatibility of a newly introduced stapler handle and reloads compared to our institution's current stapling system in a large animal survival study.
Setting:
University-affiliated animal research facility, USA.
Methods:
Matched small bowel anastomoses were created in four pigs, one with each stapler (a total of two per animal). After 14 days, investigators blinded to stapler type evaluated the anastomoses grossly and microscopically. Each anastomosis was scored on multiple measures of healing. Individual parameters were added for a global "healing score."
Results:
Clinical stapler function and gross quality of anastomoses were similar between stapler groups. Individual scores for anastomotic ulceration, reepithelialization, granulation tissue, mural healing, eosinophilic infiltration, serosal inflammation, and microscopic adherences were also statistically similar. The mean "healing scores" were equal. While this study was underpowered for subtle differences, safe and reliable performance in large animals still supports the feasibility of introducing new devices into human use.
Conclusions:
The new stapler system delivers a similar technical performance and is cross-compatible with currently marketed stapling devices. An equivalent quality device at a lower price point should enable case cost reduction, helping to maintain hospital case margin and procedure value in the face of potentially declining reimbursement. This device may provide a safe and functional alternative to currently used laparoscopic surgical staplers.
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