Recurrent Throat Infections and Tonsillectomy

Phase 4

Completed

• Conditions: Tonsillitis; Pharyngitis
• Interventions: Other: no intervention; Procedure: Tonsillectomy

• Registration Number: NCT00547391
• Lead Sponsor: Oulu University Hospital

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.

Study Timeline

• Study First Submitted: 2007-10-19
• Study First Submitted QC: 2007-10-19
• Study First Posted: 2007-10-22
• Study Start: 2007-11
• Primary Completion: 2010-12
• Study Completion: 2011-06
• Status Verified: 2012-02
• Last Update Submitted: 2012-04-17
• Last Update Posted: 2012-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	no intervention	patients on waiting list for a minimum of 5 months. These patients receive no prophylactic intervention for their recurrent pharyngitis episodes.
2	Tonsillectomy	Tonsillectomy as soon as possible after randomization (within 2-3 weeks).

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 consultation	5 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

Trial Locations

Locations (1)

Oulu University Hospital; 🇫🇮 Oulu, Finland