Tonsil Surgery in Recurrent or Chronic Tonsillitis
- Conditions
- Tonsillitis ChronicTonsillitis Recurrent
- Interventions
- Procedure: TonsillotomyProcedure: Tonsillectomy
- Registration Number
- NCT04657549
- Lead Sponsor
- Oulu University Hospital
- 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.
- Detailed Description
Rationale
Surgical removal of palatal tonsils is among the most common ear, nose and throat operations in adults in Finland. The vast majority of these operations are done for recurrent and chronic tonsillitis. Internationally accepted guidelines for the treatment of these diseases are lacking and the indications for tonsil surgery are practice-based rather than evidence-based. The choice of the surgical technique further confuses the picture. The traditional surgical technique has been the total removal of tonsils (tonsillectomy, TE). The relatively recent introduction of partial resection of tonsils, namely tonsillotomy (TT), is suggested to have the benefits of less postoperative pain and smaller risk of post-operative hemorrhage as compared to TE. The relative efficacy of these two techniques to alleviate infective tonsillar diseases is still unclear.
Objectives
The main aim of this study is to obtain reliable evidence on, whether tonsil surgery improves the quality of life in adult patients suffering from recurrent or chronic tonsillitis, and whether the lighter TT would be as effective as TE. We will also compare the scores of a generic quality of life questionnaire as well as several other subjective and objective beneficial and harmful outcomes between the groups.
Methods
In this pragmatic multi-center randomized controlled trial, adult patients suffering from recurrent or chronic tonsillitis will be randomly allocated to three groups: tonsillotomy group (TT), tonsillectomy group (TE) and control group with watchful waiting (WW) in ratio 2:2:1. The patients in the surgical groups are blinded to the operation type (TT or TE). Our hypothesis is that both surgical treatments are more effective than watchful waiting in enhancing quality of life without significant risks (superiority assumption) and that TT is non-inferior to TE when the surgical groups are compared (non-inferiority assumption). Our principal outcome is disease-specific quality of life questionnaire score (Tonsillectomy Outcome Inventory (TOI)-14) at 6 months follow-up. We have validated this questionnaire in Finnish and explored the interpretation of the scores. Secondary outcomes have been listed in the Outcomes section.
Separate random allocation lists for the main research center (Oulu University Hospital) and for the four other centers collectively as well as for recurrent and for chronic tonsillitis will be used. Random permuted blocks is used with block size varying between 5 and 10. Based on our earlier study, the principal outcome, TOI-14 score, will most probably be left-truncated at zero and right-skewed. Therefore, both tobit-analysis and covariate analysis is used with log (1+y) transformation. The primary analysis has two phases. Firstly, the TOI-14 score in the combined surgical group (TT+TE) is compared to that in the WW group. Secondly, the score in the TT group is compared to that in the TE group. Effects will be estimated by adjusted mean differences in the log-transformed scores with 95% confidence intervals. Based on our earlier observational studies on the subject, the following covariates are included in the multivariable adjusted model: gender and baseline TOI-14 score together with stratification factors: enrolling center (Oulu vs. others) and main complaint (recurrent vs. chronic tonsillitis). In case there is missing data on the primary outcome, a multiple imputation method will be used. The analyses will be performed on an intention to treat basis. Per protocol analysis will be performed as sensitivity analysis and results from comparisons on secondary outcomes and subgroup analysis (main complaint) are used to generate hypothesis for future trials.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 147
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tonsillotomy Tonsillotomy Patients will undergo tonsillotomy under general anesthesia within three weeks after enrollment. Tonsillectomy Tonsillectomy Patients will undergo tonsillectomy under general anesthesia within three weeks after enrollment.
- Primary Outcome Measures
Name Time Method Tonsillectomy Outcome Inventory -14 (TOI-14) follow-up score At the end of five to six months follow-up 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.
- Secondary Outcome Measures
Name Time Method Days with halitosis At the end of five to six months follow-up Difference in the number of days patients have bad breath (severity scaled 0-10) between the groups
Days with throat pain At the end of five to six months follow-up Difference in the number of days patients have throat pain (severity scaled 0-10) between the groups
Days with bleeding At the end of five to six months follow-up Difference in the number of days patients have bleeding from the throat (severity scaled 0-10) between the groups
Days with tonsil stones At the end of five to six months follow-up Difference in the number of days patients have bothering tonsil stones (severity scaled 0-10) between the groups
Days with dexketoprofen At the end of five to six months follow-up Difference in the number of days patients take deksketoprofen 25 mg pain medication due to throat pain between the groups
Days with acetaminophen At the end of five to six months follow-up Difference in the number of days patients take acetaminophen 1 g pain medication due to throat pain between the groups
Days with absence from work At the end of five to six months follow-up Difference in the number of days patients are absent from work or school due to throat symptoms between the groups
Days with oxycodone/naloxone At the end of five to six months follow-up Difference in the number of days patients take oxycodone/naloxone 5mg/2.5mg pain medication due to throat pain between the groups
Medical visits At the end of five to six months follow-up Difference in the number of medical visit for throat symptoms between the groups
Antibiotic courses At the end of five to six months follow-up Difference in the number of antibiotic courses for throat symptoms between the groups
Adverse effect - tightness/globus At the end of five to six months follow-up Difference in proportions having feeling of tightness/globus in throat between the groups
Adverse effect - voice problems At the end of five to six months follow-up Difference in proportions having voice problems between the groups
Adverse effect - jaw problems At the end of five to six months follow-up Difference in proportions having mandibular joint problems between the groups
Adverse effect-postoperative bleeding At the end of five to six months follow-up Frequency of postoperative bleeding in the surgical groups
Adverse effect - postoperative pain At the end of five to six months follow-up Frequency of postoperative pain in the surgical groups
Adverse effect - postoperative infection At the end of five to six months follow-up Frequency of postoperative infections in the surgical groups
Adverse effect -anesthetic complication At the end of five to six months follow-up Frequency of anesthetic complication in the surgical groups
Adverse effect - dental injury At the end of five to six months follow-up Frequency of dental injury in the surgical groups
36-Item short Form Survey (SF-36, RAND-36) follow-up score At the end of five to six months follow-up 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
Proportion benefiting At the end of five to six months follow-up Difference in proportions of patients benefiting clinically significantly from the intervention between the groups (minimum important change in TOI-14 score)
Trial Locations
- Locations (7)
Keski-Pohjanmaa Central Hospital
🇫🇮Kokkola, Finland
Turun yliopistollinen keskussairaala
🇫🇮Turku, Finland
Vaasan keskussairaala
🇫🇮Vaasa, Finland
Lapland Central Hospital
🇫🇮Rovaniemi, Lapland, Finland
Oulu University Hospital
🇫🇮Oulu, Finland
Seinäjoki Central Hospital
🇫🇮Seinäjoki, Finland
Länsi-Pohja Central Hospital
🇫🇮Kemi, Finland