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Recurrent Throat Infections and Tonsillectomy

Recurrent Throat Infections and Tonsillectomy

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00547391
Enrollment
87
Registered
2007-10-22
Start date
2007-11-30
Completion date
2011-06-30
Last updated
2012-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pharyngitis, Tonsillitis

Keywords

adults, children, tonsillectomy

Brief summary

The purpose of this study is to find out if tonsillectomy reduces the short-term risk of having an objectively confirmed (sequential changes in serum crp and procalcitonin levels) delayed pharyngitis episode among patients suffering from recurrent pharyngitis episodes. Other aims are to find out the effect of tonsillectomy to reduce the number of pharyngitis episodes or symptoms. Still, the possible disadvantages of tonsillectomy and changes in the quality of life after tonsillectomy among these patients are examined.

Detailed description

We will have a prospective randomized study. We allocated 87 consecutive patients referred for tonsillectomy randomly in two groups: tonsilectomy group or waiting list(control group). Patients in tonsillectomy group were operated as soon as possible and data on postoperative morbidity was collected. In the control group, patients were placed on our normal waiting list and they were operated on in normal time (about 5-6 months). The data on preoperative morbidity was collected. All the pharyngitis episodes were treated by a study investigator and laboratory tests (crp, procalcitonin) were taken at that time and after three days. In addition, the patients record their symptoms on a diary.

Interventions

PROCEDURETonsillectomy

Tonsillectomy under general anesthesia as a day surgery using diathermy or blunt dissection. Follow up started from the day of surgery.

OTHERno intervention

No intervention (controls). Follow up started from the day of randomization.

Sponsors

Oulu University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients selected among the cases referred to tonsillectomy for recurrent pharyngitis episodes to a tertiary care university ENT clinic (Oulu, Finland). * At least three pharyngitis episodes difficult enough for the patients to seek for medical attention during the past 12 months

Exclusion criteria

* Patients with other serious diseases (day surgery not feasible) * Patients having long time antibiotic treatment for other disease * Patients diagnosed to have peritonsillar abscess * Pregnancy * Age of 12 or under * Patients living outside Oulu or its 8 neighbouring cities (day surgery not feasible) * Patients suffering only from halitosis or bacterial plugs of palatine tonsils

Design outcomes

Primary

MeasureTime frame
Absolute percentage difference between groups of patients having pharyngitis with delayed recovery time defined by symptoms and blood sample values (crp, procalcitonin)5 months follow up

Secondary

MeasureTime frame
Absolute percentage difference of patients having group A streptococcal pharyngitis.5 months follow up
Absolute percentage difference of patients having acute pharyngitis episode with and without medical consultation5 months follow up
Difference in the number and quality (mild, severe) of symptomatic days (fever, sore throat, rhinitis, cough)5 months follow up
Absolute percentage difference having harmful effects related to tonsillectomy (haemorrhage, soft tissue burns etc.)5 months follow up

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026