Recurrent Throat Infections and Tonsillectomy

NCT ID: NCT00547391

Last Updated: 2012-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 87 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2011-06-30

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.

Conditions

Tonsillitis; Pharyngitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

patients on waiting list for a minimum of 5 months. These patients receive no prophylactic intervention for their recurrent pharyngitis episodes.

Group Type: NO_INTERVENTION

no intervention

Intervention Type: OTHER

No intervention (controls). Follow up started from the day of randomization.

2

Tonsillectomy as soon as possible after randomization (within 2-3 weeks).

Group Type: ACTIVE_COMPARATOR

Tonsillectomy

Intervention Type: PROCEDURE

Tonsillectomy under general anesthesia as a day surgery using diathermy or blunt dissection. Follow up started from the day of surgery.

Interventions

Tonsillectomy

Tonsillectomy under general anesthesia as a day surgery using diathermy or blunt dissection. Follow up started from the day of surgery.

Intervention Type: PROCEDURE

no intervention

No intervention (controls). Follow up started from the day of randomization.

Intervention Type: OTHER

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

• Minimum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oulu University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Petri Koivunen, MD

Role: PRINCIPAL_INVESTIGATOR

Dept of Otolaryngology, University of Oulu, Finland

Aila Kristo, MD

Role: PRINCIPAL_INVESTIGATOR

Dept of Otolaryngology, University of Oulu, Finland

Onni Niemelä

Role: PRINCIPAL_INVESTIGATOR

Laboratory, University of Oulu, Finland

Markku Koskela

Role: PRINCIPAL_INVESTIGATOR

Microbiological Laboratory, University of Oulu, Finland

Timo J Koskenkorva, MD

Role: PRINCIPAL_INVESTIGATOR

Dept of Otolaryngology, University of Oulu, Finland

Olli-Pekka Alho, professor

Role: STUDY_CHAIR

Dept of Otolaryngology, University of Oulu, Finland

Locations

Oulu University Hospital

Oulu, , Finland

Countries

Finland

References

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.

Reference Type: DERIVED

PMID: 23549975 (View on PubMed)

Other Identifiers

Diary nr 106/2007

Identifier Type: -

Identifier Source: org_study_id