Safety and Feasibility of a Lower-Cost Stapler in Bariatric Surgery.

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Abstrakt

Tytuł:: Safety and Feasibility of a Lower-Cost Stapler in Bariatric Surgery.
Autorzy:: Roberts KE; Department of Surgery, Gastrointestinal Section, Yale University, 40 Temple Street, Suite 7B, New Haven, CT, 06510, USA.
Renee Hilton L; Department of Surgery, Gastrointestinal Section, Yale University, 40 Temple Street, Suite 7B, New Haven, CT, 06510, USA.; Department of Surgery, Minimally Invasive and Digestive Diseases, Augusta University, Augusta, GA, USA.
Friedman DT; Department of Surgery, Gastrointestinal Section, Yale University, 40 Temple Street, Suite 7B, New Haven, CT, 06510, USA. .
Frieder JS; Universidad Central de Venezuela, Caracas, Venezuela.
Zhang X; Department of Surgical Pathology, Yale University, New Haven, CT, 06520, USA.
Duffy AJ; Department of Surgery, Gastrointestinal Section, Yale University, 40 Temple Street, Suite 7B, New Haven, CT, 06510, USA.
Źródło:: Obesity surgery [Obes Surg] 2019 Feb; Vol. 29 (2), pp. 401-405.
Typ publikacji:: Evaluation Study; Journal Article; Research Support, Non-U.S. Gov't
Język:: English
Imprint Name(s):: Publication: 2006- : New York : Springer Science + Business Media
Original Publication: Oxford, OX, UK : Rapid Communications of Oxford, [1991-
MeSH Terms:: Bariatric Surgery*/economics
Bariatric Surgery*/instrumentation
Bariatric Surgery*/methods
Bariatric Surgery*/mortality
Obesity, Morbid/*surgery
Surgical Staplers/*economics
Surgical Stapling/*economics
Surgical Stapling/*instrumentation
Anastomosis, Surgical/economics ; Anastomosis, Surgical/instrumentation ; Anastomosis, Surgical/methods ; Anastomosis, Surgical/mortality ; Animals ; Costs and Cost Analysis ; Disease Models, Animal ; Feasibility Studies ; Humans ; Intestine, Small/pathology ; Intestine, Small/surgery ; Laparoscopy/economics ; Laparoscopy/instrumentation ; Laparoscopy/methods ; Laparoscopy/mortality ; Obesity, Morbid/economics ; Obesity, Morbid/mortality ; Obesity, Morbid/pathology ; Surgical Stapling/methods ; Surgical Stapling/mortality ; Swine
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Contributed Indexing:: Keywords: Bariatric surgery; New technology; Surgical devices; Value
Entry Date(s):: Date Created: 20181110 Date Completed: 20191230 Latest Revision: 20200309
Update Code:: 20240105
DOI:: 10.1007/s11695-018-3580-6
PMID:: 30411224
: Czasopismo naukowe

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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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