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Recurrent Throat Infections and Tonsillectomy

Primary Purpose

Tonsillitis, Pharyngitis

Status
Completed
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
Tonsillectomy
no intervention
Sponsored by
Oulu University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tonsillitis focused on measuring adults, children, tonsillectomy

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Oulu University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

1

2

Arm Description

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

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

Outcomes

Primary Outcome Measures

Absolute percentage difference between groups of patients having pharyngitis with delayed recovery time defined by symptoms and blood sample values (crp, procalcitonin)

Secondary Outcome Measures

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

Full Information

First Posted
October 19, 2007
Last Updated
April 17, 2012
Sponsor
Oulu University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00547391
Brief Title
Recurrent Throat Infections and Tonsillectomy
Official Title
Recurrent Throat Infections and Tonsillectomy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oulu University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tonsillitis, Pharyngitis
Keywords
adults, children, tonsillectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
87 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
No Intervention
Arm Description
patients on waiting list for a minimum of 5 months. These patients receive no prophylactic intervention for their recurrent pharyngitis episodes.
Arm Title
2
Arm Type
Active Comparator
Arm Description
Tonsillectomy as soon as possible after randomization (within 2-3 weeks).
Intervention Type
Procedure
Intervention Name(s)
Tonsillectomy
Intervention Description
Tonsillectomy under general anesthesia as a day surgery using diathermy or blunt dissection. Follow up started from the day of surgery.
Intervention Type
Other
Intervention Name(s)
no intervention
Intervention Description
No intervention (controls). Follow up started from the day of randomization.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Absolute percentage difference of patients having group A streptococcal pharyngitis.
Time Frame
5 months follow up
Title
Absolute percentage difference of patients having acute pharyngitis episode with and without medical consultation
Time Frame
5 months follow up
Title
Difference in the number and quality (mild, severe) of symptomatic days (fever, sore throat, rhinitis, cough)
Time Frame
5 months follow up
Title
Absolute percentage difference having harmful effects related to tonsillectomy (haemorrhage, soft tissue burns etc.)
Time Frame
5 months follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Petri Koivunen, MD
Organizational Affiliation
Dept of Otolaryngology, University of Oulu, Finland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Aila Kristo, MD
Organizational Affiliation
Dept of Otolaryngology, University of Oulu, Finland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Onni Niemelä
Organizational Affiliation
Laboratory, University of Oulu, Finland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Markku Koskela
Organizational Affiliation
Microbiological Laboratory, University of Oulu, Finland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Timo J Koskenkorva, MD
Organizational Affiliation
Dept of Otolaryngology, University of Oulu, Finland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Olli-Pekka Alho, professor
Organizational Affiliation
Dept of Otolaryngology, University of Oulu, Finland
Official's Role
Study Chair
Facility Information:
Facility Name
Oulu University Hospital
City
Oulu
Country
Finland

12. IPD Sharing Statement

Citations:
PubMed Identifier
23549975
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.
Results Reference
derived

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Recurrent Throat Infections and Tonsillectomy

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