Evidence map›Paper›PMID 34294123›Full record

ArticleTrials2021

Tonsillectomy versus tonsillotomy for recurrent acute tonsillitis in children and adults (TOTO): study protocol for a randomized non-inferiority trial.

Orlando Guntinas-Lichius, Katharina Geißler, Thomas Asendorf, Ralf Tostmann, Jan Löhler

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 2 pooled it
1.0field-weighted citation impact, top 26% 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

8 citing papers in PubMed, 2 syntheses or guidelines pooled it, 15 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pediatric intracapsular tonsillectomy: a comprehensive review and expert perspective.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 · 2026
    Review
  4. Article
  5. Article
  6. Article
  7. [Effect of tonsillotomy on the inflammation and immune function in children with chronic tonsillitis].Lin chuang er bi yan hou tou jing wai ke za zhi = Journal of clinical otorhinolaryngology head and neck surgery · 2023
    Article
  8. Review
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

5 authors at 4 institutions in 1 country.

Orlando Guntinas-LichiusDepartment of Otorhinolaryngology, Jena University Hospital, Am Klinikum 1, 07747, Jena, Germany. orlando.guntinas@med.uni-jena.de.ORCID http://orcid.org/0000-0001-9671-0784
Katharina GeißlerDepartment of Otorhinolaryngology, Jena University Hospital, Am Klinikum 1, 07747, Jena, Germany.
Thomas AsendorfDepartment of Medical Statistics, University Medical Center Göttingen, Göttingen, Germany.
Ralf TostmannThe German Study Centre for Otorhinolaryngology, Head and Neck Surgery (DSZ-HNO), Bonn, Germany.
Jan LöhlerThe German Study Centre for Otorhinolaryngology, Head and Neck Surgery (DSZ-HNO), Bonn, Germany.
Universitätsmedizin Göttingen · DEGerman Centre for Higher Education Research and Science Studies · DEHNO Bad Bramstedt · DEJena University Hospital · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTonsillectomy is one of the most frequently performed surgeries in children and young adults worldwide. For decades, tonsillectomy was the surgical treatment of choice for recurrent acute tonsillitis. Tonsillotomy was used in some countries as an alternative to tonsillectomy only for the treatment of obstructive sleep apnea in young children. In recent years, an increase of tonsillotomy also to treat recurrent acute tonsillitis can be observed. Therefore, the German Institute for Quality and Efficiency in Health Care (IQWiG) was commissioned by the Federal Joint Committee (G-BA) to investigate whether tonsillotomy offers advantages compared to tonsillectomy. The meta-analysis of the IQWiG including studies until 2016 revealed that the long-term benefits and harms of tonsillotomy compared to tonsillectomy are unclear. Consequently, the G-BA performed a European call for a clinical trial. A consortium of the German Professional Association of ENT-surgeons (BVHNO), the German Society of Oto-Rhino-Laryngology, Head and Neck Surgery (DGHNO-KHC), and the Jena University Hospital were finally selected to perform the TOTO study.

methodsTOTO is a multicenter, 1:1 two-arm, randomized non-blinded non-inferiority trial. Four hundred fifty-four patients ≥ 3 years of age will be randomly allocated to undergo either tonsillotomy or tonsillectomy as surgical treatment of recurrent acute tonsillitis. All participants will be followed up for a total of 24 months. The primary outcome is the number of sore throat days experienced over the 24-month follow-up. DISCUSSION: TOTO is designed to evaluate the effectiveness and efficiency of tonsillectomy versus tonsillectomy for the management of patients with recurrent acute tonsillitis. Tonsil disease and surgery have a major impact on preschool and school children as well as on economically active young adults, with individual and societal costs through loss of school visits, earnings, and productivity. If tonsillotomy is at least as effective as tonsillectomy but with reduced morbidity, this would reduce costs to the healthcare system and society.

trial registrationGerman Clinical Trials Register DRKS00020823 . Registered on 04 September 2020.

Indexed as

PharyngitisSleep Apnea, ObstructiveTonsillectomyTonsillitisChildChild, PreschoolEquivalence Trials as TopicHumansMeta-Analysis as TopicMulticenter Studies as TopicYoung AdultRandomized controlled trialSore throatSurgeryTonsillectomyTonsillitisTonsillotomy

Identifiers

PMID34294123
PMCPMC8296750
OpenAlexW3184868553

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.