Evidence map›Paper›PMID 34338876›Full record

Trial reportEuropean archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery2022

A novel electrosurgical divider: performance in a self-controlled tonsillectomy study.

Gerold Besser, Stefan Grasl, Elias L Meyer, Julia Schnoell, Tina J Bartosik, Faris F Brkic, Gregor Heiduschka

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03793816 (Tonsillectomy Using BiZact™ - a Randomized Side-controlled Clinical Trial), which is not on this map. Cited by 3 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 2 pooled it
1.1field-weighted citation impact, top 25% 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.

NCT03793816 nacompletednot on this map

Tonsillectomy Using BiZact™ - a Randomized Side-controlled Clinical Trial

TypeinterventionalSponsorMedical University of ViennaRan2019 to 2020Enrolled48ConditionsTonsillitis Chronic, Tonsillectomy, Hemorrhage, Postoperative PainArmsBiZactTM Open Sealer/Divider
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 2 syntheses or guidelines pooled it, 9 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. BiZact versus cold steel for post-tonsillectomy hemorrhage: a multicenter randomized trial.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2025
    Trial
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors at 1 institution in 1 country.

Gerold BesserDepartment of Otorhinolaryngology, Head and Neck Surgery, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria. gerold.besser@meduniwien.ac.at.ORCID http://orcid.org/0000-0003-3168-7477
Stefan GraslDepartment of Otorhinolaryngology, Head and Neck Surgery, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria.ORCID http://orcid.org/0000-0001-9523-7489
Elias L MeyerSection for Medical Statistics, CeMSIIS, Medical University of Vienna, Vienna, Austria.
Julia SchnoellDepartment of Otorhinolaryngology, Head and Neck Surgery, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria.ORCID http://orcid.org/0000-0001-9772-4395
Tina J BartosikDepartment of Otorhinolaryngology, Head and Neck Surgery, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria.ORCID http://orcid.org/0000-0002-6326-7402
Faris F BrkicDepartment of Otorhinolaryngology, Head and Neck Surgery, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria.ORCID http://orcid.org/0000-0002-0770-6677
Gregor HeiduschkaDepartment of Otorhinolaryngology, Head and Neck Surgery, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria.ORCID http://orcid.org/0000-0003-1862-5992
Medical University of Vienna · AT

Funding

Medtronic ERP-2018-11289
6 · The paper itself

Abstract

purposeTonsillectomies are among the most common surgeries in otorhinolaryngology. A novel electrosurgical temperature-controlled instrument (device) promises rapid tonsillectomies and might reduce postoperative pain, but comparative studies to assess performance are warranted.

methodsThis randomized self-controlled clinical trial was conducted from October 2019 to October 2020 at the Department of Otorhinolaryngology, Head and Neck Surgery of the Medical University of Vienna. Forty-eight patients underwent a tonsillectomy with the device on one side and using cold-steel with localized bipolar cauterization on the other side (control). Main outcomes were the time for tonsil removal (per side) and the time to stop bleeding (per side). Secondary measurements were postoperative pain, assessed once on day 0 and five times on days 1, 3, 5, 7, and 10. Postoperative bleeding episodes and consequences were recorded.

resultsDevice tonsillectomies were performed significantly faster than controls; the mean surgical time difference was 209 s (p < 0.001, 95% CI 129; 288). Intraoperative blood loss was significantly lower on the device side (all p < 0.05). Postoperative measurements of pain and bleeding were similar for both sides. Two return-to-theatre secondary bleeding events were recorded for the control side.

conclusionThe novel electrosurgical temperature-controlled divider reduced the tonsillectomy surgical time and intraoperative blood loss, with no apparent negative effects on postoperative pain or bleeding, compared to a cold-steel tonsillectomy with localized bipolar cauterization. In time-restricted settings, the device could be beneficial, particularly after familiarization with device handling.

trial registrationClinicalTrials.gov Identifier: NCT03793816.

Indexed as

TonsillectomyTonsillitisBlood Loss, SurgicalElectrosurgeryHumansPalatine TonsilPostoperative HemorrhagePostoperative PainHaemorrhagePainPalatine tonsilSurgical deviceTonsillitis

Identifiers

PMID34338876
PMCPMC8930875
OpenAlexW3189859573

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

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.