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
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Sponsor:
Oulu University Hospital
Information provided by (Responsible Party):
Oulu University Hospital
Tracking Information | |||||||||||||||||||
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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 |
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 |
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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 |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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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. |
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Recruitment Information | |||||||||||||||||||
Recruitment Status ICMJE | Completed | ||||||||||||||||||
Actual Enrollment ICMJE |
87 | ||||||||||||||||||
Original Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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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 |