Recurrent Throat Infections and Tonsillectomy

Oulu University Hospital

Status and phase: Completed; Phase 4

Conditions: Pharyngitis; Tonsillitis

Treatments: Other: no intervention; Procedure: Tonsillectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT00547391

Diary nr 106/2007

Details and patient eligibility

About

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.

Full 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.

Enrollment: 87 patients

Sex: All

Ages: 13+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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87 participants in 2 patient groups

1

No Intervention group

Description:

patients on waiting list for a minimum of 5 months. These patients receive no prophylactic intervention for their recurrent pharyngitis episodes.

Treatment:

Other: no intervention

2

Active Comparator group

Description:

Tonsillectomy as soon as possible after randomization (within 2-3 weeks).

Treatment:

Procedure: Tonsillectomy