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Recurrent Throat Infections and Tonsillectomy

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ClinicalTrials.gov Identifier: NCT00547391
Recruitment Status : Completed
First Posted : October 22, 2007
Last Update Posted : April 19, 2012
Sponsor:
Information provided by (Responsible Party):
Oulu University Hospital

Tracking Information
First Submitted Date  ICMJE October 19, 2007
First Posted Date  ICMJE October 22, 2007
Last Update Posted Date April 19, 2012
Study Start Date  ICMJE November 2007
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 19, 2007)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 19, 2007)
  • Absolute percentage difference of patients having group A streptococcal pharyngitis. [ Time Frame: 5 months follow up ]
  • Absolute percentage difference of patients having acute pharyngitis episode with and without medical consultation [ Time Frame: 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 ]
  • Absolute percentage difference having harmful effects related to tonsillectomy (haemorrhage, soft tissue burns etc.) [ Time Frame: 5 months follow up ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Recurrent Throat Infections and Tonsillectomy
Official Title  ICMJE Recurrent Throat Infections and Tonsillectomy
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Tonsillitis
  • Pharyngitis
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • No Intervention: 1
    patients on waiting list for a minimum of 5 months. These patients receive no prophylactic intervention for their recurrent pharyngitis episodes.
    Intervention: Other: no intervention
  • Active Comparator: 2
    Tonsillectomy as soon as possible after randomization (within 2-3 weeks).
    Intervention: Procedure: Tonsillectomy
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 17, 2012)
87
Original Estimated Enrollment  ICMJE
 (submitted: October 19, 2007)
110
Actual Study Completion Date  ICMJE June 2011
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00547391
Other Study ID Numbers  ICMJE Diary nr 106/2007
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Oulu University Hospital
Study Sponsor  ICMJE Oulu University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Oulu University Hospital
Verification Date February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP