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Completed

NCT Number: NCT00547391

Recurrent Throat Infections and Tonsillectomy

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.

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Key information

Age range

13 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Oulu University Hospital

Oulu, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tonsillectomy

Procedure

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

No intervention

Other

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

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)

    Time frame: 5 months follow up

Secondary outcomes

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

    Time frame: 5 months follow up

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

    Time frame: 5 months follow up

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

    Time frame: 5 months follow up

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

    Time frame: 5 months follow up

Sponsors and collaborators

Lead sponsor

Oulu University Hospital

Other

Registry information

Important dates

Study start
2007
Primary completion
2010
Study completion
2011
First posted
Oct 22, 2007
Registry last updated
Apr 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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