Surgical Treatment of Tonsillar Abscess

April 5, 2023 updated by: François Voruz, University Hospital, Geneva

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Incision drainage
Adult 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.
Procedure: Incision drainage

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.
Active Comparator: Tonsillectomy
Adult 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.
Procedure: Tonsillectomy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of treatment success (%)
Time Frame: 3 days
Disappearance of fever if any + decrease in leukocytosis and CRP value + no sign of recollection nor cervical extension of the infection.
3 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence rate (%)
Time Frame: 3 and 12 months
Reccurence of a tonsillar abscess on the same side post-operatively.
3 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Geneva

Investigators

  • Principal Investigator: François Voruz, MD, University Hospital, Geneva

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

May 31, 2024

Study Registration Dates

First Submitted

September 2, 2020

First Submitted That Met QC Criteria

September 2, 2020

First Posted (Actual)

September 10, 2020

Study Record Updates

Last Update Posted (Actual)

April 7, 2023

Last Update Submitted That Met QC Criteria

April 5, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-01516

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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