Recurrent Throat Infections and Tonsillectomy

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

Tracking Information

• First Submitted Date: October 19, 2007
• First Posted Date: October 22, 2007
• Last Update Posted Date: April 19, 2012
• Study Start Date: November 2007
• Actual Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Recurrent Throat Infections and Tonsillectomy
• Official Title: 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Tonsillitis
• Pharyngitis

Intervention

• 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

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 17, 2012): 87
• Original Estimated Enrollment (submitted: October 19, 2007): 110
• Actual Study Completion Date: June 2011
• Actual Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 13 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Finland

Administrative Information

• NCT Number: NCT00547391
• Other Study ID Numbers: Diary nr 106/2007
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Oulu University Hospital
• Study Sponsor: Oulu University Hospital
• Collaborators: Not Provided

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

• PRS Account: Oulu University Hospital
• Verification Date: February 2012