NCT00547391

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2007

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 19, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 22, 2007

Completed
10 days until next milestone

Study Start

First participant enrolled

November 1, 2007

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

April 19, 2012

Status Verified

February 1, 2012

Enrollment Period

3.1 years

First QC Date

October 19, 2007

Last Update Submit

April 17, 2012

Conditions

TonsillitisPharyngitis

Keywords

adultschildrentonsillectomy

Outcome Measures

Primary Outcomes (1)

  • Absolute percentage difference between groups of patients having pharyngitis with delayed recovery time defined by symptoms and blood sample values (crp, procalcitonin)

    5 months follow up

Secondary Outcomes (4)

  • Absolute percentage difference of patients having group A streptococcal pharyngitis.

    5 months follow up

  • Absolute percentage difference of patients having acute pharyngitis episode with and without medical consultation

    5 months follow up

  • Difference in the number and quality (mild, severe) of symptomatic days (fever, sore throat, rhinitis, cough)

    5 months follow up

  • Absolute percentage difference having harmful effects related to tonsillectomy (haemorrhage, soft tissue burns etc.)

    5 months follow up

Study Arms (2)

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

2

ACTIVE COMPARATOR

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

Procedure: Tonsillectomy

Interventions

TonsillectomyPROCEDURE

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

2
no interventionOTHER

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

1

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oulu University Hospital

Oulu, Finland

Location

Related Publications (1)

  • 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.

    PMID: 23549975DERIVED

MeSH Terms

Conditions

TonsillitisPharyngitis

Interventions

Tonsillectomy

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsPharyngeal DiseasesStomatognathic DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Otorhinolaryngologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

  • Olli-Pekka Alho, professor

    Dept of Otolaryngology, University of Oulu, Finland

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2007

First Posted

October 22, 2007

Study Start

November 1, 2007

Primary Completion

December 1, 2010

Study Completion

June 1, 2011

Last Updated

April 19, 2012

Record last verified: 2012-02

Locations

FI(1)