Evidence map›Paper›PMID 26208498›Full record

ArticleSurgical endoscopy2016

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

Andreas Kuthe, Alexander Haemmerle, Kaja Ludwig, Stephan Falck, Wolfgang Hiller, Frederick Mainik, Stephan Freys, Lev Dubovoy, Joachim Jaehne, Karl Oldhafer

Open access · hybridAbstract readMulticenter Study
In one paragraph

Article in Surgical endoscopy, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.5field-weighted citation impact, top 31% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 7 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
  4. A Single Institution Review of Initial Application of a 5-mm Stapler.Journal of laparoendoscopic & advanced surgical techniques. Part A · 2016
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 5 institutions in 1 country.

Andreas KutheDRK-Krankenhaus Clementinenhaus, Allgemein-, Viszeral- und Unfallchirurgie, Lützerodestr. 1, 30161, Hannover, Germany. akuthe@clementinenhaus.de.
Alexander HaemmerleSana Klinikum Hameln-Pyrmont, Klinik für Allgemein- und Visceralchirurgie, Saint-Maur-Platz 1, 31785, Hameln, Germany.
Kaja LudwigKlinikum Suedstadt Rostock, Klinik für Allgemein- und Visceralchirurgie, Sudring 81, 18059, Rostock, Germany.
Stephan FalckAsklepios Klinik Barmbek, Allgemein-, Viszeralchirurgie, Rübenkamp 220, 22291, Hamburg, Germany.
Wolfgang HillerKlinikum Lippe, Allgemein- und Viszeralchirurgie Detmold, Röntgenstraße 18, 32756, Detmold, Germany.
Frederick MainikDRK-Krankenhaus Clementinenhaus, Allgemein-, Viszeral- und Unfallchirurgie, Lützerodestr. 1, 30161, Hannover, Germany.
Stephan FreysDIAKO Ev. Diakonie-Krankenhaus, Klinik für Allgemein-und Visceralchirurgie, Gröpelinger Heerstraße 406 - 408, 28239, Bremen, Germany.
Lev DubovoyHenriettenstiftung Hannover, Klinik für Allgemein- und Visceralchirurgie, Marienstraße 72-90, 30171, Hannover, Germany.
Joachim JaehneHenriettenstiftung Hannover, Klinik für Allgemein- und Visceralchirurgie, Marienstraße 72-90, 30171, Hannover, Germany.
Karl OldhaferAsklepios Klinik Barmbek, Allgemein-, Viszeralchirurgie, Rübenkamp 220, 22291, Hamburg, Germany.
Asklepios Klinik Barmbek · DEHannoversche Kinderheilanstalt · DEMartin-Luther-Krankenhaus · DEKlinikum Lippe · DEKlinikum Südstadt Rostock · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe objective of this study was to evaluate the safety and efficacy of a novel 5-mm laparoscopic linear stapler in clinical gastrointestinal surgical applications.

methodsA 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.

resultsSeven 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.

conclusionThe 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.

Indexed as

Surgical StaplersAdultAgedFemaleGastrointestinal DiseasesGastrointestinal TractHumansLaparoscopyMaleMiddle AgedPostoperative ComplicationsProspective StudiesSurgical StaplingAnastomosisLaparoscopic surgeryLaparoscopyStaplesSurgical stapler

Identifiers

PMID26208498
PMCPMC4848340
OpenAlexW1841786669

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.