Tonsil Surgery in Recurrent or Chronic Tonsillitis
Partial or Total Surgical Removal of Palatal Tonsils to Change Quality of Life for Adults With Chronic or Recurrent Tonsillitis: Randomized Controlled Trial.
1 other identifier
interventional
147
1 country
7
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2020
Typical duration for not_applicable
7 active sites
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
November 16, 2020
CompletedFirst Posted
Study publicly available on registry
December 8, 2020
CompletedStudy Start
First participant enrolled
December 8, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 9, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 9, 2023
CompletedJune 12, 2023
June 1, 2023
2.5 years
November 16, 2020
June 9, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (20)
36-Item short Form Survey (SF-36, RAND-36) follow-up score
At the end of five to six months follow-up
Proportion benefiting
At the end of five to six months follow-up
Days with throat pain
At the end of five to six months follow-up
Days with halitosis
At the end of five to six months follow-up
Days with bleeding
At the end of five to six months follow-up
- +15 more secondary outcomes
Study Arms (3)
Tonsillectomy
ACTIVE COMPARATORPatients will undergo tonsillectomy under general anesthesia within three weeks after enrollment.
Tonsillotomy
ACTIVE COMPARATORPatients will undergo tonsillotomy under general anesthesia within three weeks after enrollment.
Watchful waiting
NO INTERVENTIONPatients will be closely monitored for the 5-6 months monitoring period.
Interventions
Tonsillectomy is done by monopolar electrocautery, bipolar scissors or cold instruments. First the mucosa of the anterior palatinal arch is incised and tonsillar capsule identified, then tonsillar tissue is removed along the capsule. Any bleeding is coagulated either with monopolar or bipolar electrocautery.
Tonsillotomy is done using monopolar electrosurgery, bipolar scissors or coblator device. Most of the tonsillar tissue is removed, exceeding the removal behind the line between anterior and posterior palatinal arch so that only thin layer of tonsil tissue is left over the tonsillar capsule.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Age less than 18 years
- Pregnancy
- History of peritonsillar abscess
- Previous illness that make prompt same-day surgery unfeasible
- No electronic identity verification tools
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Lapland Central Hospital
Rovaniemi, Lapland, FIN-96400, Finland
Länsi-Pohja Central Hospital
Kemi, FIN-94100, Finland
Keski-Pohjanmaa Central Hospital
Kokkola, FIN-67200, Finland
Oulu University Hospital
Oulu, FIN-90029, Finland
Seinäjoki Central Hospital
Seinäjoki, FIN-60220, Finland
Turun yliopistollinen keskussairaala
Turku, Finland
Vaasan keskussairaala
Vaasa, Finland
Related Publications (3)
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.
PMID: 32060601BACKGROUNDKoskenkorva 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.
PMID: 24863677BACKGROUNDLaajala 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.
PMID: 34526073BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Olli-Pekka Alho, MD, PhD
Oulu University Hospital, University of Oulu
- STUDY CHAIR
Aleksi EJ Laajala, MD
Oulu University Hospital, University of Oulu
- STUDY CHAIR
Paulus Tokola, MD
Oulu University Hospital, University of Oulu
- STUDY CHAIR
Timo J Autio, MD, PhD
Oulu University Hospital
- STUDY CHAIR
Timo J Koskenkorva, MD, PhD
University of Oulu
- STUDY CHAIR
Pasi Ohtonen, M. Sc.
Division of Operative Care, Oulu University Hospital, Finland
- STUDY CHAIR
Esa Läärä, PhD.
Oulu University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Patients in active arms don't know if they are in tonsillectomy or tonsillotomy group
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, MD
Study Record Dates
First Submitted
November 16, 2020
First Posted
December 8, 2020
Study Start
December 8, 2020
Primary Completion
June 9, 2023
Study Completion
June 9, 2023
Last Updated
June 12, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- Study protocol will be sent for publication within 12 months from the beginning of recruiting. Data from the study will be available starting six months after publication.
- Access Criteria
- The data generated or analyzed during this study will be available from the corresponding investigator on reasonable request.
Study protocol that includes the Informed Consent Form will be sent to a journal for publication, Statistical analysis Plan will be published later in ClinicalTrials.gov web site. The data generated or analyzed during this study will be available from the corresponding investigator on reasonable request.