Recurrent Throat Infections and Tonsillectomy - Full Text View

Sponsored by:	Oulu University Hospital
Information provided by:	Oulu University Hospital
ClinicalTrials.gov Identifier:	NCT00547391

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 IV

MedlinePlus related topics: Sore Throat Tonsils and Adenoids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:	Recurrent Throat Infections and Tonsillectomy

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	110
Study Start Date:	November 2007
Estimated Study Completion Date:	December 2009

Arms	Assigned Interventions
1: No Intervention 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.
2: Active Comparator 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 allocate 110 consecutive patients referred for tonsillectomy randomly in two groups: tonsilectomy group or waiting list(control group). Patients in tonsillectomy group will be operated as soon as possible and data on postoperative morbidity is collected. In the control group, patients are placed on our normal waiting list and they will be operated on in normal time (about 5-6 months). The data on preoperative morbidity is collected. All the pharyngitis episodes are treated by a study investigator and laboratory tests (crp, procalcitonin) are 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

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

Contacts

Contact: Timo J Koskenkorva, MD	+35883153466	timo.koskenkorva@ppshp.fi
Contact: Olli-Pekka Alho, professor	+35883153473	olli-pekka.alho@oulu.fi

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

More Information

No publications provided

Study ID Numbers:	Diary nr 106/2007
Study First Received:	October 19, 2007
Last Updated:	October 19, 2007
ClinicalTrials.gov Identifier:	NCT00547391 History of Changes
Health Authority:	Finland: National Agency for Medicines

Keywords provided by Oulu University Hospital:

adults
children
tonsillectomy

Study placed in the following topic categories:

Otorhinolaryngologic Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Anesthetics
Tonsillitis

Stomatognathic Diseases
Pharyngitis
Pharyngeal Diseases
Recurrence

Additional relevant MeSH terms:

Otorhinolaryngologic Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Tonsillitis

Stomatognathic Diseases
Pharyngitis
Pharyngeal Diseases

ClinicalTrials.gov processed this record on May 07, 2009