Multicenter prospective evaluation of a new articulating 5-mm endoscopic linear stapler
| Autor: | Joachim Jaehne, W. F. A. Hiller, Kaja Ludwig, Stephan Falck, Lev Dubovoy, Frederick Mainik, Alexander Haemmerle, Karl J. Oldhafer, Stephan Freys, Andreas Kuthe |
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| Rok vydání: | 2015 |
| Předmět: |
Adult
Male Laparoscopic surgery medicine.medical_specialty Gastrointestinal Diseases Anastomosis medicine.medical_treatment 030230 surgery Article Prospective evaluation 03 medical and health sciences Postoperative Complications Surgical Staplers 0302 clinical medicine Internal medicine Surgical Stapling medicine Humans Prospective Studies Surgical stapler Laparoscopy Prospective cohort study Aged medicine.diagnostic_test business.industry General surgery Middle Aged Hepatology equipment and supplies Surgery Gastrointestinal Tract surgical procedures operative Staples Female 030211 gastroenterology & hepatology business Abdominal surgery |
| Zdroj: | Surgical Endoscopy |
| ISSN: | 1432-2218 0930-2794 |
| DOI: | 10.1007/s00464-015-4406-4 |
| Popis: | Background The objective of this study was to evaluate the safety and efficacy of a novel 5-mm laparoscopic linear stapler in clinical gastrointestinal surgical applications. Methods A prospective, single-arm study with an open enrollment of subjects requiring stapling of the gastrointestinal (GI) tract was performed. The study endpoints were the number of complications and technical failures associated with the use of a novel stapler when compared to similar events with conventional staplers as described in the medical literature. Results Seven centers enrolled 160 subjects, 150 of which were followed up to at least 30 days postoperatively. Intraoperative success: In 423 deployments, there were two staple line leaks and five staple line bleeds, all of which were intraoperatively resolved. In addition, incomplete staple lines were noted as a result of user error (n = 15) or device-related issues (n = 22), all of which were immediately resolved and none of which resulted in a complication or a change of the surgical procedure. Late outcomes: A total of 13 surgical complications in 160 patients were related to a GI transection or anastomosis, 12 of which related to a hand-sewn anastomosis or use of other commercially available staplers. One event (1/153, 0.065 %) on POD 1, involving bleeding of the staple line, was felt to be related to the use of the new stapler. Conclusion The study confirmed that the new device was user-friendly (9 % incidence of problems firing the device), reliable (3 % device failures) and safe ( |
| Databáze: | OpenAIRE |
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