An interventional study of Tonsillectomy and Tonsillotomy in Tonsillitis Recurrent and Tonsillitis Chronic, sponsored by Oulu University Hospital. Completed at 7 sites in Finland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-12.
Sponsored by Oulu University Hospital · Not applicable, Interventional, and Treatment
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.
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.
103 studies on the registry are indexed under Tonsillitis; 12 are open to participants now.
This study's enrollment of 147 is above the median of 100 across 87 interventional studies indexed under Tonsillitis.
Browse Tonsillitis studies →Oulu University Hospital is the lead sponsor of 40 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The inclusion criteria are:
Recurrent tonsillitis episodes:
Chronic tonsillitis:
The exclusion criteria are:
Patients will undergo tonsillectomy under general anesthesia within three weeks after enrollment.
Procedure: Tonsillectomy
Patients will undergo tonsillotomy under general anesthesia within three weeks after enrollment.
Procedure: Tonsillotomy
Patients will be closely monitored for the 5-6 months monitoring period.
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.
Also known as: Extracapsular tonsillectomy, ECTE
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.
Also known as: Intracapsular tonsillectomy, ICTE. Subtotal/intracapsular/partial tonsillectomy, SIPT.
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.
Time frame: At the end of five to six months follow-up
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
Time frame: At the end of five to six months follow-up
Proportion benefiting
Difference in proportions of patients benefiting clinically significantly from the intervention between the groups (minimum important change in TOI-14 score)
Time frame: At the end of five to six months follow-up
Days with throat pain
Difference in the number of days patients have throat pain (severity scaled 0-10) between the groups
Time frame: At the end of five to six months follow-up
Days with halitosis
Difference in the number of days patients have bad breath (severity scaled 0-10) between the groups
Time frame: At the end of five to six months follow-up
Days with bleeding
Difference in the number of days patients have bleeding from the throat (severity scaled 0-10) between the groups
Time frame: At the end of five to six months follow-up
Days with tonsil stones
Difference in the number of days patients have bothering tonsil stones (severity scaled 0-10) between the groups
Time frame: At the end of five to six months follow-up
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
Time frame: At the end of five to six months follow-up
Days with dexketoprofen
Difference in the number of days patients take deksketoprofen 25 mg pain medication due to throat pain between the groups
Time frame: At the end of five to six months follow-up
Days with acetaminophen
Difference in the number of days patients take acetaminophen 1 g pain medication due to throat pain between the groups
Time frame: At the end of five to six months follow-up
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
Time frame: At the end of five to six months follow-up
Medical visits
Difference in the number of medical visit for throat symptoms between the groups
Time frame: At the end of five to six months follow-up
Antibiotic courses
Difference in the number of antibiotic courses for throat symptoms between the groups
Time frame: At the end of five to six months follow-up
Adverse effect-postoperative bleeding
Frequency of postoperative bleeding in the surgical groups
Time frame: At the end of five to six months follow-up
Adverse effect - postoperative pain
Frequency of postoperative pain in the surgical groups
Time frame: At the end of five to six months follow-up
Adverse effect - postoperative infection
Frequency of postoperative infections in the surgical groups
Time frame: At the end of five to six months follow-up
Adverse effect - dental injury
Frequency of dental injury in the surgical groups
Time frame: At the end of five to six months follow-up
Adverse effect -anesthetic complication
Frequency of anesthetic complication in the surgical groups
Time frame: At the end of five to six months follow-up
Adverse effect - tightness/globus
Difference in proportions having feeling of tightness/globus in throat between the groups
Time frame: At the end of five to six months follow-up
Adverse effect - voice problems
Difference in proportions having voice problems between the groups
Time frame: At the end of five to six months follow-up
Adverse effect - jaw problems
Difference in proportions having mandibular joint problems between the groups
Time frame: At the end of five to six months follow-up
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — 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.
Supporting information: Study protocol, Informed consent form
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.
Ran from Dec 2020 to primary completion in Jun 2023, 30 months.
Of 29 non-industry interventional studies with no phase under Tonsillitis, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 49. This study's 30 months is above that.
Counting every sponsor, half of 29 studies reached it within 20 months; a quarter within 10 and three quarters within 49.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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Oulu University Hospital