Recurrent Throat Infections and Tonsillectomy

April 17, 2012 updated by: Oulu University Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

87

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Oulu, Finland
        • Oulu University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 1
patients on waiting list for a minimum of 5 months. These patients receive no prophylactic intervention for their recurrent pharyngitis episodes.
Other: no intervention
No intervention (controls). Follow up started from the day of randomization.
Active Comparator: 2
Tonsillectomy as soon as possible after randomization (within 2-3 weeks).
Procedure: Tonsillectomy
Tonsillectomy under general anesthesia as a day surgery using diathermy or blunt dissection. Follow up started from the day of surgery.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oulu University Hospital

Investigators

  • Principal Investigator: Petri Koivunen, MD, Dept of Otolaryngology, University of Oulu, Finland
  • Principal Investigator: Aila Kristo, MD, Dept of Otolaryngology, University of Oulu, Finland
  • Principal Investigator: Onni Niemelä, Laboratory, University of Oulu, Finland
  • Principal Investigator: Markku Koskela, Microbiological Laboratory, University of Oulu, Finland
  • Principal Investigator: Timo J Koskenkorva, MD, Dept of Otolaryngology, University of Oulu, Finland
  • Study Chair: Olli-Pekka Alho, professor, Dept of Otolaryngology, University of Oulu, Finland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

October 19, 2007

First Submitted That Met QC Criteria

October 19, 2007

First Posted (Estimate)

October 22, 2007

Study Record Updates

Last Update Posted (Estimate)

April 19, 2012

Last Update Submitted That Met QC Criteria

April 17, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Diary nr 106/2007

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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