Multicenter prospective evaluation of a new articulating 5-mm endoscopic linear stapler

Abstract

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 (<1 % complication rate related to the stapler). Based on these results, it would seem that this new 5-mm stapler is a safe and effective alternative to standard 12-mm staplers.

Keywords: Anastomosis; Laparoscopic surgery; Laparoscopy; Staples; Surgical stapler.

Fig. 1

Comparison of “D-Shaped” (left) and “B-Shaped” (right) and staple forms. Pre-deployment forms are shown on the top and post-deployment forms are shown on the bottom

Fig. 2

Technical description of MicroCutter XCHANGE 30

Fig. 3

MicroCutter XCHANGE 30 End-effector in 80° articulation

Fig. 4

Surgical procedures

Fig. 5

Consort Diagram

Fig. 6

Rate of instrument failures over the enrollment period