Recurrent Throat Infections and Tonsillectomy

Pharyngitis Clinical Trial

Official title:

Recurrent Throat Infections and Tonsillectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00547391
• Other study ID #: Diary nr 106/2007
• Status: Completed
• Phase: Phase 4
• First received: October 19, 2007
• Last updated: April 17, 2012
• Start date: November 2007
• Est. completion date: June 2011

Study information

• Verified date: February 2012
• Source: Oulu University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: June 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pharyngitis
• Tonsillitis

Intervention

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

Other:
• no intervention
No intervention (controls). Follow up started from the day of randomization.

Locations

Country	Name	City	State
Finland	Oulu University Hospital	Oulu

Sponsors (1)

Lead Sponsor	Collaborator
Oulu University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Absolute percentage difference of patients having group A streptococcal pharyngitis.		5 months follow up	No
Secondary	Absolute percentage difference of patients having acute pharyngitis episode with and without medical consultation		5 months follow up	No
Secondary	Difference in the number and quality (mild, severe) of symptomatic days (fever, sore throat, rhinitis, cough)		5 months follow up	No
Secondary	Absolute percentage difference having harmful effects related to tonsillectomy (haemorrhage, soft tissue burns etc.)		5 months follow up	No