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

ABSTRACT: 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.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.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.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.

SUBMITTER: Kuthe A

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

REPOSITORIES: biostudies-literature

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

Kuthe Andreas A Haemmerle Alexander A Ludwig Kaja K Falck Stephan S Hiller Wolfgang W Mainik Frederick F Freys Stephan S Dubovoy Lev L Jaehne Joachim J Oldhafer Karl K

Surgical endoscopy 20150725 5

<h4>Background</h4>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.<h4>Methods</h4>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 conventio ...[more]

PMID: 26208498

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Project description:BackgroundBillroth I (B-I) gastroduodenostomy is an anastomotic procedure that is widely performed after gastric resection for distal gastric cancer. A circular stapler often is used for B-I gastroduodenostomy in open and laparoscopic-assisted distal gastrectomy. Recently, totally laparoscopic distal gastrectomy (TLDG) has been considered less invasive than laparoscopic-assisted gastrectomy, and many institutions performing laparoscopic-assisted distal gastrectomy are trying to progress to TLDG without markedly changing the anastomosis method. The purpose of this report is to introduce the technical details of new methods of intracorporeal gastroduodenostomy using either a circular or linear stapler and to evaluate their technical feasibility and safety.MethodsSeventeen patients who underwent TLDG with the intracorporeal double-stapling technique using a circular stapler (n = 7) or the book-binding technique (BBT) using a linear stapler (n = 10) between February 2010 and April 2011 were enrolled in the study. Clinicopathological data, surgical data, and postoperative outcomes were analyzed.ResultsThere were no intraoperative complications or conversions to open surgery in any of the 17 patients. The usual postoperative complications following gastroduodenostomy, such as anastomotic leakage and stenosis, were not observed. Anastomosis took significantly longer to complete with DST (64 ± 24 min) than with BBT (34 ± 7 min), but more stapler cartridges were needed with BBT than with DST.ConclusionsTLDG using a circular or linear stapler is feasible and safe to perform. DST will enable institutions performing laparoscopic-assisted distal gastrectomy with circular staplers to progress to TLDG without problems, and this progression may be more economical because fewer stapler cartridges are used during surgery. However, if an institution has already been performing δ anastomosis in TLDG but has been experiencing certain issues with δ anastomosis, converting from δ anastomosis to BBT should be beneficial.

Project description:BackgroundMotorized articulating laparoscopic instruments (ALI) offer more degrees of freedom than conventional laparoscopic instruments (CLI). However, a difficult learning curve and complex instrument handling are still a problem of ALI. We compared the performance of new prototypes of motorized ALI with CLI in a series of standardized laparoscopic tasks performed by laparoscopic novices. Further, usability of the new ALI was assessed.MethodsA randomized cross-over study with 50 laparoscopic novices who either started with CLI and then changed to ALI (CA) or vice versa (AC) was conducted. All participants performed the European training in basic laparoscopic urological skills (E-BLUS) with each instrument in given order. Time and errors were measured for each exercise. Instrument usability was assessed.ResultsOverall, using CLI was significantly faster (CLI 4:27 min vs. ALI 4:50 min; p-value 0.005) and associated with fewer exercise failures in needle guidance (CLI 0 vs. ALI 12; p-value 0.0005) than ALI. Median amount of errors was similar for both instruments. Instrument sequence did not matter, as CA and AC showed comparable completion times. Regarding the learning effect, participants were significantly faster in the second attempt of exercises than in the first. In the needle guidance task, participants using CLI last demonstrated a significant speed improvement, whereas ALI were significantly slower in the second run. Regarding usability, CLI were preferred over ALI due to lighter weight and easier handling. Nevertheless, participants valued ALI's additional degrees of freedom.ConclusionUsing new motorized ALI in the E-BLUS examination by laparoscopic novices led to a worse performance compared to CLI. An explanation could be that participants felt overwhelmed by ALI and that ALI have an own distinct learning curve. As participants valued ALI's additional degrees of freedom, however, a future application of ALI could be for training purposes, ideally in combination with CLI.

Project description:IntroductionTotal gastrectomy is often recommended for upper body gastric cancer, and totally laparoscopic total gastrectomy (TLTG) is deemed to be a promising surgical method with the well-known advantages such as less invasion and fast recovery. However, the anastomosis between oesophagus and jejunum is the difficulty of TLTG. Although staplers have promoted the development of TLTG, the choice of suitable staplers to complete oesophagojejunostomy is controversial and unclear. Therefore, a higher level of research evidence is needed to compare the two types of staplers in terms of safety and efficacy for oesophagojejunostomy in TLTG among patients with gastric cancer.Methods and analysisPubMed, Embase, Cochrane Library, China National Knowledge Infrastructure (CNKI) and Wanfang Databases will be comprehensively searched from January 1990 to July 2019. All eligible randomised controlled trials (RCTs), non-RCTs or observational studies comparing the two types of staplers will be included. A meta-analysis will be performed using Review Manager V.5.3 software to compare the safety and efficacy of linear and circular staplers for oesophagojejunostomy in TLTG. The primary outcomes are anastomotic leakage, anastomotic stricture, anastomotic haemorrhage. The secondary outcomes include time to first instance of passing gas after surgery, first feeding time, total operation time, reconstruction time, estimated blood loss. The heterogeneity of this study will be assessed by p values and I2 statistic. Subgroup analyses and sensitivity analyses will be used to explore and explain the heterogeneity. The risk of bias will be assessed using the Cochrane tool or the Newcastle-Ottawa Quality Assessment Scale.Ethics and disseminationEthical approval will not be required because this proposed systematic review and meta-analysis is based on previously published data, which does not include intervention data on patients. The findings of this study will be submitted to a peer-reviewed journal and will be presented at a relevant congress.Prospero registration numberCRD42018111680.

Dataset Information

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

Publications

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

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