Clinical trial NCT00547391: Recurrent Throat Infections and Tonsillectomy
Official title: Recurrent Throat Infections and Tonsillectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tonsillitis
Pharyngitis
Keywords: adults
children
tonsillectomy
Lead sponsor: Oulu University Hospital
Sponsor class: OTHER
First posted: 2007-10-22
Enrollment: 87
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Absolute percentage difference between groups of patients having pharyngitis with delayed recovery time defined by symptoms and blood sample values (crp, procalcitonin)
timeFrame: 5 months follow up
Secondary outcomes:
measure: Absolute percentage difference of patients having group A streptococcal pharyngitis.
timeFrame: 5 months follow up
measure: Absolute percentage difference of patients having acute pharyngitis episode with and without medical consultation
timeFrame: 5 months follow up
measure: Difference in the number and quality (mild, severe) of symptomatic days (fever, sore throat, rhinitis, cough)
timeFrame: 5 months follow up
measure: Absolute percentage difference having harmful effects related to tonsillectomy (haemorrhage, soft tissue burns etc.)
timeFrame: 5 months follow up
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: Oulu University Hospital
Study officials:
affiliation: Dept of Otolaryngology, University of Oulu, Finland
name: Petri Koivunen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept of Otolaryngology, University of Oulu, Finland
name: Aila Kristo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Laboratory, University of Oulu, Finland
name: Onni Niemelä
role: PRINCIPAL_INVESTIGATOR
affiliation: Microbiological Laboratory, University of Oulu, Finland
name: Markku Koskela
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept of Otolaryngology, University of Oulu, Finland
name: Timo J Koskenkorva, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept of Otolaryngology, University of Oulu, Finland
name: Olli-Pekka Alho, professor
role: STUDY_CHAIR
References:
citation: Koskenkorva T, Koivunen P, Koskela M, Niemela O, Kristo A, Alho OP. Short-term outcomes of tonsillectomy in adult patients with recurrent pharyngitis: a randomized controlled trial. CMAJ. 2013 May 14;185(8):E331-6. doi: 10.1503/cmaj.121852. Epub 2013 Apr 2.