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 intr

SUBMITTER: Kuthe A 

PROVIDER: S-EPMC4848340 | biostudies-literature | 2016 May

REPOSITORIES: biostudies-literature