Surgical Treatment of Tonsillar Abscess

Tonsillar Abscess Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04543708
• Other study ID #: 2020-01516
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: May 31, 2024

Study information

• Verified date: April 2023
• Source: University Hospital, Geneva
• Contact: François Voruz, MD
• Phone: +141795533927
• Email: francois.voruz[@]hcuge.ch
• Is FDA regulated: No
• Study type: Interventional

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: May 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Abscess
• Peritonsillar Abscess
• Tonsillar Abscess

Intervention

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.
• 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.

Locations

Country	Name	City	State
Switzerland	University Hospitalas Geneva	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

References & Publications (18)

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. — View Citation

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. — View Citation

Chowdhury CR, Bricknell MC. The management of quinsy--a prospective study. J Laryngol Otol. 1992 Nov;106(11):986-8. doi: 10.1017/s002221510012153x. — View Citation

Clerc S, Soldati D. [Socioeconomic aspects in the therapy of peritonsillar absscess]. Schweiz Med Wochenschr. 2000;Suppl 125:17S-19S. French. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Yung AK, Cantrell RW. Quinsy tonsillectomy. Laryngoscope. 1976 Nov;86(11):1714-7. doi: 10.1288/00005537-197611000-00015. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 days
Secondary	Recurrence rate (%)	Reccurence of a tonsillar abscess on the same side post-operatively.	3 and 12 months