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Tonsillar AbscessNCT04543708

Surgical Treatment of Tonsillar Abscess

A study testing Incision drainage and Tonsillectomy in people with Tonsillar Abscess, run by University Hospital, Geneva at 1 site in Switzerland.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The diagnosis and treatment of tonsillar abscess are very physician-dependent, as sufficient prospective medical literature is lacking to choose the most efficient regimen. The proposed study aims to assess the therapeutic efficacy of tonsillectomy compared to drainage under local anesthesia. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Tonsillar Abscess
What is being tested?
Incision drainage and Tonsillectomy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteSwitzerland
Study dates
1 Oct 2020to 22 Feb 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients ≥18 years of age with clinical suspicion of unilateral tonsillar abscess without signs of "extra-capsular" complication.
  • Obtaining informed consent.

Who cannot join

  • Contraindications to injected CT or drainage in local anesthesia (allergy to iodinated contrast product, allergy to local anesthetics, phobia of needles, major trismus).
  • Parapharyngeal or retropharyngeal abscess, or associated venous thrombosis found on CT.
  • Imminent threat to the upper respiratory tract (glottic edema, acute dyspnea).
  • Inability to understand the different procedures (dementia, impossible communication, substance abuse).
  • Anamnestic pregnancy.
  • Antiaggregant or anticoagulant treatment.
  • Treatment of corticosteroids during the management of emergencies and in hospital.

Trial locations and contacts

1 site in 1 country.

Switzerland1 site
  • University Hospitalas Geneva

    Geneva, Canton of Geneva, 1211

Other trials in Switzerland

About this study

Official title: Treatment of Tonsillar Abscess: A Randomized Clinical Trial in a Tertiary Center

The diagnosis and treatment of tonsillar abscess are very physician-dependent, as sufficient prospective medical literature is lacking to choose the most efficient regimen. The proposed study aims to assess the therapeutic efficacy of tonsillectomy compared to drainage under local anesthesia. This is a prospective, randomized clinical trial in adults in a tertiary care center in Geneva (Switzerland).

Read the detailed description

Introduction:

Tonsillar abscess is the most common complication of acute bacterial angina. The abscess is located in the majority of cases in the capsular space and occasionally within the tonsil itself. The ethiopathogenesis is polymicrobial, composed mainly of Streptococcus Pyogenes (aerobic) and Fusobacterium Necrophorum (anaerobe). This condition mainly affects young adults, smokers and significantly impacts quality of life. Symptoms are noisy, characterized by severe odynodysphagia, often limited mouth opening (trismus), and occasionally dyspnea, fever, and decreased general condition. Its complications include upper airway obstruction, spread of infection into the deep tissues of the neck and mediastinum, septic venous thrombosis, and arterial hemorrhage from contact necrosis. The descriptions of the management of this pathology are centuries old, but even today there is a need to drain the pus. We estimate that around 200 patients per year present to our University Hospital in Geneva (Switzerland) with suspected tonsillar abscess.

Diagnosis:

The medical literature describes several diagnostic methods without clear consensus on the most effective. The doctor's clinical suspicion varies according to the examiner's experience, although certain criteria are recognized as good predictors of the presence of an abscess (trismus, edema, uvula deviation, "hot potato voice", reflex otalgia), but with limited sensitivity and specificity. When clinically suspected, confirmation of the presence of pus can be determined by direct puncture or drainage, allowing immediate diagnosis, but with a high proportion of false negatives and requiring a painful invasive procedure. Ultrasound (US) and Computed Tomography (CT) provide a painless diagnosis, but US requires a specific oral probe and may be unfeasible in case of trismus, and its interpretation is very examiner-dependent. CT remains an irradiating, costly and time-consuming exam, but it is sensitive and can formally exclude any associated complication (venous thrombosis, retro- or parapharyngeal extension, contralateral involvement). The gold-standard for the diagnosis of a tonsillar abscess is the direct visualization of pus during drainage.

Treatment:

Regarding the treatment, here too the evidence-based literature is not clear about the most effective (except in children, in whom local anesthesia intervention is most of the time impractical). It usually consists of a combination of medical and surgical therapy. Medical therapy generally includes - in addition to hydration and pain-killers - intravenous antibiotics and requires approximately 3 days of hospitalization. There are several described technics for the surgical drainage. Repeated needle punctures, incisional drainage under local anesthesia, and tonsillectomy under general anesthesia. The latter two are favored because they are more effective on immediate pain. To our knowledge, only two prospective randomized studies (partially for one) of 51 and 53 patients have studied the efficacy of these two interventions and their conclusions only relate to the absence of difference in the length of hospital stay.

The retrospective data show good efficacy of both modalities (incision drainage under local anesthesia vs tonsillectomy under general anesthesia) and the choice of their execution is strongly center- and physician-dependent. Incision drainage avoids general anesthesia but is extremely unpleasant, requiring repeated rinsing which is painful for the patient and time-consuming for the medical team. This modality is grafted with a failure rate of around 20% in the literature as well as in our own experience, requiring further tonsillectomy under general anesthesia. Furthermore, the recurrence rate is estimated at 9-22%. Conversely, the first-line tonsillectomy requires a general anesthesia but immediately relieves some of the pain and the trismus, allows an almost certain resolution of the infection, prevents any recurrence, seems economically more advantageous and does not require the collaboration of the patient during the procedure.

As the medical literature does not offer clear guidelines based on prospective trials, the proposed study aims to prospectively evaluate the therapeutic efficacy of the tonsillectomy compared to the drainage under local anesthesia.

This is a prospective, randomized clinical trial by adults in a tertiary care center in Geneva (Switzerland).

Being tested
Incision drainage, Tonsillectomy
Keywords
Tonsil, Abscess, Tonsillectomy, Local anesthesia, CT-scan
Medical subject headings
Abscess

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Incision drainageProcedure or surgery

    Oropharyngeal pre-anesthesia is performed with 10% xylocaine spray, then submucosal anesthesia of the anterior pillar of the tonsil is performed with 2 ml of Rapidocaine or Rapidocaine 1 or 2% adrenaline. A scalpel incision is made with the search for the abscess pocket with a crile. If pus is present, a NaCl / Betadine rinse is performed. A syringe puncture can help locate the abscess if needed. The duration is approximately 15 minutes.

    If no purulent pouch is found, the procedure is completed with tonsillectomy under general anesthesia.

  • TonsillectomyProcedure or surgery

    Under general anesthesia, in dorsal decubitus, an autostatic mouth opener is placed, an incision of the anterior pillar of the tonsil allows the opening of the capsular space, along which the entire tonsil is dissected until complete extraction, hemostasis is performed, then the patient is awakened. The duration is approximately 30 minutes.

Study groups in NCT04543708
Study groupRoleWhat they receive
Incision drainageActive comparatorAdult with clinical suspicion of tonsillar abscess who underwent a CT-scan confirming the abscess will be randomly assigned to one arm or the other. "Incision drainage" arm will benefit from drainage of the tonsillar abscess under local anesthesia and then be hospitalized for intravenous antibiotics. If the incision drainage fails, they will get a tonsillectomy under general anesthesia.
Receives: Procedure: Incision drainage
TonsillectomyActive comparatorAdult with clinical suspicion of tonsillar abscess who underwent a CT-scan confirming the abscess will be randomly assigned to one arm or the other. "Tonsillectomy" arm will benefit from tonsillectomy under general anesthesia and then be hospitalized for intravenous antibiotics.
Receives: Procedure: Tonsillectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of treatment success (%)

    Disappearance of fever if any + decrease in leukocytosis and CRP value + no sign of recollection nor cervical extension of the infection.

    Measured: 3 days

Secondary outcomes (1)
  1. Recurrence rate (%)

    Reccurence of a tonsillar abscess on the same side post-operatively.

    Measured: 3 and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2020
  2. Study start1 Oct 2020
  3. Primary completion22 Feb 2024
  4. Study completion22 Feb 2024

Why it stopped: For efficacy reasons

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04543708
Sponsor's protocol ID
2020-01516
Status last verified
Apr 2026
First submitted
2 Sep 2020
Last updated
1 May 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Powell EL, Powell J, Samuel JR, Wilson JA. A review of the pathogenesis of adult peritonsillar abscess: time for a re-evaluation. J Antimicrob Chemother. 2013 Sep;68(9):1941-50. doi: 10.1093/jac/dkt128. Epub 2013 Apr 23.

    PubMed 23612569
  • Windfuhr JP, Toepfner N, Steffen G, Waldfahrer F, Berner R. Clinical practice guideline: tonsillitis II. Surgical management. Eur Arch Otorhinolaryngol. 2016 Apr;273(4):989-1009. doi: 10.1007/s00405-016-3904-x. Epub 2016 Feb 16.

    PubMed 26882912
  • Albertz N, Nazar G. Peritonsillar abscess: treatment with immediate tonsillectomy - 10 years of experience. Acta Otolaryngol. 2012 Oct;132(10):1102-7. doi: 10.3109/00016489.2012.684399. Epub 2012 Jun 18.

    PubMed 22708633
  • Lehnerdt G, Senska K, Fischer M, Jahnke K. [Smoking promotes the formation of peritonsillar abscesses]. Laryngorhinootologie. 2005 Sep;84(9):676-9. doi: 10.1055/s-2005-870289. German.

    PubMed 16142623
  • Powell J, Powell EL, Conroy K, Hopkins C, Moor JW, Wilson JA. Throat-related quality of life in peritonsillar abscess sufferers: application of the adult tonsil outcome inventory. J Laryngol Otol. 2013 Dec;127(12):1190-3. doi: 10.1017/S0022215113003071. Epub 2013 Nov 20.

    PubMed 24252628
  • Grant MC, Raggio B, Barton B, Guarisco JL. Establishing the Need for an Evidence-Based Treatment Algorithm for Peritonsillar Abscess in Children. Clin Pediatr (Phila). 2018 Oct;57(12):1385-1390. doi: 10.1177/0009922818778048. Epub 2018 May 29.

    PubMed 29808740
  • Scott PM, Loftus WK, Kew J, Ahuja A, Yue V, van Hasselt CA. Diagnosis of peritonsillar infections: a prospective study of ultrasound, computerized tomography and clinical diagnosis. J Laryngol Otol. 1999 Mar;113(3):229-32. doi: 10.1017/s0022215100143634.

    PubMed 10435129
  • Salihoglu M, Eroglu M, Yildirim AO, Cakmak A, Hardal U, Kara K. Transoral ultrasonography in the diagnosis and treatment of peritonsillar abscess. Clin Imaging. 2013 May-Jun;37(3):465-7. doi: 10.1016/j.clinimag.2012.09.023. Epub 2012 Oct 25.

    PubMed 23102927
  • Carratola MC, Frisenda G, Gastanaduy M, Guarisco JL. Association of Computed Tomography With Treatment and Timing of Care in Adult Patients With Peritonsillar Abscess. Ochsner J. 2019 Winter;19(4):309-313. doi: 10.31486/toj.18.0168.

    PubMed 31903053
  • Patel KS, Ahmad S, O'Leary G, Michel M. The role of computed tomography in the management of peritonsillar abscess. Otolaryngol Head Neck Surg. 1992 Dec;107(6 Pt 1):727-32. doi: 10.1177/019459988910700603.1.

    PubMed 1470448
  • Teschner M, Aljeraisi T, Giesemann A, Gotz F, Lenarz T, Kontorinis G. [The role of CT in the diagnosis of peritonsillar abscesses after Punctio Sicca]. Laryngorhinootologie. 2013 Jan;92(1):25-9. doi: 10.1055/s-0032-1327709. Epub 2012 Nov 19. German.

    PubMed 23165703
  • Johnson RF, Stewart MG, Wright CC. An evidence-based review of the treatment of peritonsillar abscess. Otolaryngol Head Neck Surg. 2003 Mar;128(3):332-43. doi: 10.1067/mhn.2003.93.

    PubMed 12646835
  • Powell J, Wilson JA. An evidence-based review of peritonsillar abscess. Clin Otolaryngol. 2012 Apr;37(2):136-45. doi: 10.1111/j.1749-4486.2012.02452.x.

    PubMed 22321140
  • Hur K, Zhou S, Kysh L. Adjunct steroids in the treatment of peritonsillar abscess: A systematic review. Laryngoscope. 2018 Jan;128(1):72-77. doi: 10.1002/lary.26672. Epub 2017 May 31.

    PubMed 28561258
  • Fagan JJ, Wormald PJ. Quinsy tonsillectomy or interval tonsillectomy--a prospective randomised trial. S Afr Med J. 1994 Oct;84(10):689-90.

    PubMed 7839259

Questions about this trial

What is this clinical trial studying?

A study testing Incision drainage and Tonsillectomy in people with Tonsillar Abscess, run by University Hospital, Geneva at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: For efficacy reasons). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of treatment success (%) (time frame: 3 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04543708, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.

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