Recurrent Throat Infections and Tonsillectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Oulu University Hospital
ClinicalTrials.gov Identifier:
NCT00547391
First received: October 19, 2007
Last updated: April 17, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Tonsillitis
Pharyngitis
Procedure: Tonsillectomy
Other: no intervention
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Recurrent Throat Infections and Tonsillectomy

Resource links provided by NLM:


Further study details as provided by Oulu University Hospital:

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) [ Time Frame: 5 months follow up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Absolute percentage difference of patients having group A streptococcal pharyngitis. [ Time Frame: 5 months follow up ] [ Designated as safety issue: No ]
  • Absolute percentage difference of patients having acute pharyngitis episode with and without medical consultation [ Time Frame: 5 months follow up ] [ Designated as safety issue: No ]
  • Difference in the number and quality (mild, severe) of symptomatic days (fever, sore throat, rhinitis, cough) [ Time Frame: 5 months follow up ] [ Designated as safety issue: No ]
  • Absolute percentage difference having harmful effects related to tonsillectomy (haemorrhage, soft tissue burns etc.) [ Time Frame: 5 months follow up ] [ Designated as safety issue: No ]

Enrollment: 87
Study Start Date: November 2007
Study Completion Date: June 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00547391

Locations
Finland
Oulu University Hospital
Oulu, Finland
Sponsors and Collaborators
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
  More Information

No publications provided by Oulu University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Oulu University Hospital
ClinicalTrials.gov Identifier: NCT00547391     History of Changes
Other Study ID Numbers: Diary nr 106/2007
Study First Received: October 19, 2007
Last Updated: April 17, 2012
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by Oulu University Hospital:
adults
children
tonsillectomy

Additional relevant MeSH terms:
Pharyngitis
Tonsillitis
Otorhinolaryngologic Diseases
Pharyngeal Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Stomatognathic Diseases

ClinicalTrials.gov processed this record on October 29, 2014