Tonsillitis Chronic Clinical Trial
Official title:
Partial or Total Surgical Removal of Palatal Tonsils to Change Quality of Life for Adults With Chronic or Recurrent Tonsillitis: Randomized Controlled Trial.
Verified date | June 2023 |
Source | Oulu University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Tonsil surgery is common in adults with recurrent or chronic tonsillitis. The surgical techniques include either partial or total surgical removal of the palatal tonsils (tonsillotomy, TT, and tonsillectomy, TE, respectively). The aim of this study is to find out, whether tonsil surgery improves the quality of life in these patients and whether the lighter TT is as effective as TE. Our main outcome is the disease-specific Tonsillectomy Outcome Inventory-14 (TOI-14) quality of life questionnaire score at 6 months follow-up.
Status | Completed |
Enrollment | 147 |
Est. completion date | June 9, 2023 |
Est. primary completion date | June 9, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | The inclusion criteria are: - Recurrent tonsillitis episodes: - At least 4 episodes in the previous 12 months or at least 3 episodes in 6 months - Episodes are disabling, prevent normal functioning and are severe enough for the patient to seek medical attention - Episodes are thought to involve the palatine tonsils based on signs found during the episodes (e.g. edema, erythema, exudative tonsillitis, anterior cervical lymphadenitis) - No throat cultures or antigen/molecular tests to show infection with group A streptococcus are needed - Chronic tonsillitis: - Recurrent or chronic throat pain for at least 6 months - At least one symptom or sign that indicate that symptoms originate from the palatal tonsils (disturbing tonsil stones, halitosis, anterior cervical lymphadenitis, tonsillar exudates, abnormal tonsillar crypts) - Symptomatic treatment has not been effective The exclusion criteria are: - Age less than 18 years - Pregnancy - History of peritonsillar abscess - Previous illness that make prompt same-day surgery unfeasible - No electronic identity verification tools |
Country | Name | City | State |
---|---|---|---|
Finland | Länsi-Pohja Central Hospital | Kemi | |
Finland | Keski-Pohjanmaa Central Hospital | Kokkola | |
Finland | Oulu University Hospital | Oulu | |
Finland | Lapland Central Hospital | Rovaniemi | Lapland |
Finland | Seinäjoki Central Hospital | Seinäjoki | |
Finland | Turun yliopistollinen keskussairaala | Turku | |
Finland | Vaasan keskussairaala | Vaasa |
Lead Sponsor | Collaborator |
---|---|
Oulu University Hospital |
Finland,
Koskenkorva T, Koivunen P, Laara E, Alho OP. Predictive factors for quality of life after tonsillectomy among adults with recurrent pharyngitis: a prospective cohort study. Clin Otolaryngol. 2014 Aug;39(4):216-23. doi: 10.1111/coa.12263. — View Citation
Laajala A, Autio TJ, Ohtonen P, Alho OP, Koskenkorva TJ. Interpretation of Tonsillectomy Outcome Inventory-14 scores: a prospective matched cohort study. Eur Arch Otorhinolaryngol. 2020 May;277(5):1499-1505. doi: 10.1007/s00405-020-05832-z. Epub 2020 Feb 14. — View Citation
Laajala A, Tokola P, Autio TJ, Koskenkorva T, Tastula M, Ohtonen P, Laara E, Alho OP. Total or partial tonsillar resection (tonsillectomy or tonsillotomy) to change the quality of life for adults with recurrent or chronic tonsillitis: study protocol for a randomised controlled trial. Trials. 2021 Sep 15;22(1):617. doi: 10.1186/s13063-021-05539-4. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Tonsillectomy Outcome Inventory -14 (TOI-14) follow-up score | TOI-14 is a disease-specific quality of life questionnaire for throat related symptoms in adults. TOI-14 summary scores vary between 0 and 100 with higher values indicating poorer quality of life. Analysis is described in the Detailed Description section. | At the end of five to six months follow-up | |
Secondary | 36-Item short Form Survey (SF-36, RAND-36) follow-up score | Difference in RAND-36 domains scores between groups. RAND-36 instrument produces eight individual values between 0 and 100 (one for each domain), with higher scores indicating better quality of life | At the end of five to six months follow-up | |
Secondary | Proportion benefiting | Difference in proportions of patients benefiting clinically significantly from the intervention between the groups (minimum important change in TOI-14 score) | At the end of five to six months follow-up | |
Secondary | Days with throat pain | Difference in the number of days patients have throat pain (severity scaled 0-10) between the groups | At the end of five to six months follow-up | |
Secondary | Days with halitosis | Difference in the number of days patients have bad breath (severity scaled 0-10) between the groups | At the end of five to six months follow-up | |
Secondary | Days with bleeding | Difference in the number of days patients have bleeding from the throat (severity scaled 0-10) between the groups | At the end of five to six months follow-up | |
Secondary | Days with tonsil stones | Difference in the number of days patients have bothering tonsil stones (severity scaled 0-10) between the groups | At the end of five to six months follow-up | |
Secondary | Days with absence from work | Difference in the number of days patients are absent from work or school due to throat symptoms between the groups | At the end of five to six months follow-up | |
Secondary | Days with dexketoprofen | Difference in the number of days patients take deksketoprofen 25 mg pain medication due to throat pain between the groups | At the end of five to six months follow-up | |
Secondary | Days with acetaminophen | Difference in the number of days patients take acetaminophen 1 g pain medication due to throat pain between the groups | At the end of five to six months follow-up | |
Secondary | Days with oxycodone/naloxone | Difference in the number of days patients take oxycodone/naloxone 5mg/2.5mg pain medication due to throat pain between the groups | At the end of five to six months follow-up | |
Secondary | Medical visits | Difference in the number of medical visit for throat symptoms between the groups | At the end of five to six months follow-up | |
Secondary | Antibiotic courses | Difference in the number of antibiotic courses for throat symptoms between the groups | At the end of five to six months follow-up | |
Secondary | Adverse effect-postoperative bleeding | Frequency of postoperative bleeding in the surgical groups | At the end of five to six months follow-up | |
Secondary | Adverse effect - postoperative pain | Frequency of postoperative pain in the surgical groups | At the end of five to six months follow-up | |
Secondary | Adverse effect - postoperative infection | Frequency of postoperative infections in the surgical groups | At the end of five to six months follow-up | |
Secondary | Adverse effect - dental injury | Frequency of dental injury in the surgical groups | At the end of five to six months follow-up | |
Secondary | Adverse effect -anesthetic complication | Frequency of anesthetic complication in the surgical groups | At the end of five to six months follow-up | |
Secondary | Adverse effect - tightness/globus | Difference in proportions having feeling of tightness/globus in throat between the groups | At the end of five to six months follow-up | |
Secondary | Adverse effect - voice problems | Difference in proportions having voice problems between the groups | At the end of five to six months follow-up | |
Secondary | Adverse effect - jaw problems | Difference in proportions having mandibular joint problems between the groups | At the end of five to six months follow-up |
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