Recovery From Tonsil Surgery.

Overview

The goal of this study is to optimize the duration of sick leave and the usage of opioids following partial tonsillar surgery in adults by comparing the recovery after extracapsular tonsillectomy (ECTE) with recovery after intracapsular tonsillectomy (ICTE). An additional objective is to confirm that ICTE is as effective as ECTE when comparing TOI-14 scores after 12 months post-operatively. The main questions the study aims to answer are: * Is 10 days sick leave enough after partial tonsillectomy (ICTE)? * Are opioids needed at all after partial tonsillectomy (ICTE)? * Is ICTE as effective as ECTE when comparing TOI-14 symptom scores after 12 months from the surgery? Adult patients who are scheduled to tonsil surgery are randomised into 2 groups: ICTE and ECTE. Patients are blinded. Postoperatively they will answer structured questions about the recovery and effectiveness of the surgery. The last follow up survey is 60 months after the surgery.

General Study Outline * Adult patients scheduled for day-surgery tonsillectomy based on out-patient clinic evaluation done by ENT specialists will be recruited starting January 2026. A participant information sheet will be given to these patients. * If the patient is scheduled to tonsil surgery by referral letter, the participant information sheet will be sent along with other materials related to the surgery. * Research doctor will contact the patient by phone to inquire about their interest in participating the study and to assess the eligibility. If the patient expresses interest and meets the inclusion criteria more detailed information will be provided by phone. The number of patients meeting the inclusion criteria, those who are invited to participate, and those who provide informed consent will be recorded. If the patient is eligible and will participate the study, a consent will be obtained. With their written informed consent, all patients will be registered into a common electronic database (Research Electronic Data Capture, REDCap 10.6.9 2021 Vanderbilt University, Nashville, Tennessee, USA) at the University of Turku and the baseline patient-reported outcome measure questionnaires will be sent by e-mail (RedCap). * On the morning of the surgery baseline data will be checked and patients will be randomized to undergo either intracapsular tonsillectomy using coblation instrument or extracapsular tonsillectomy using monopolar, both day surgery. 10 days of sick-leave will be written to all patients. Non-steroidal anti-inflammatory drugs (NSAIDs) and paracetamol are advised to use as analgesics. Rescue opioid is prescribed. * On the day 7 after the surgery study coordinator will call each patient and ask structured questions. * Days 0-14 after surgery, patients will fill in data about recovery and usage of analgesics. Data is recorded in RedCap. * Follow-up surveys via RedCap will be sent after 1, 12, 24 and 60 months after the surgery. Patients and Methods Eligibility criteria The indication for tonsil surgery will be due to clinical condition. The patient is eligible for this study if the indication for the surgery is: at least 3 tonsillitis during the last 12 months or chronic tonsillitis, which is defined as a prolonged tonsil-derived throat pain and at least one symptom or sign indicating that symptoms are tonsil-related (ie. enlarged tonsils, tonsillar exudates, halitosis, tonsillar stones, enlarged and tender submandibular lymph nodes). Additionally, these symptoms should have affected patient's everyday life for at least 3 months. The diagnosis and the decision of the tonsil surgery along with a general ORL examination will be made by otorhinolaryngologist at a visit to out-patient clinic. Surgery will be scheduled according to queue situation. Recruitment Research doctors will recruit patients from the tonsillectomy queue via phone call. Furthermore, inclusion and exclusion criteria will be verified on the phone and an assessment for eligibility form filled in and recorded in RedCap and on the servers of The wellbeing services county of Southwest Finland (VARHA). Sufficient information is given to the patient to make an informed decision, both verbally and in written form. Patients will receive a participant information sheet to read before giving consent. They will be given the opportunity to ask questions about the research. Participation in the study is voluntary for the patient. All patients called are considered assessed for eligibility and the data will be stored anonymously. Additionally, all non-eligible patients, along with the reasons for ineligibility, will be documented. Those who are eligible but choose not to participate will also be recorded anonymously. Finally, a study group will be formed consisting of eligible patients who have provided written consents. Consent and registration A written informed consent will be collected from all study participants before any study procedures. The ENT surgeon who operates the patient will collect the written consent before the surgery in the morning. Clinical and other study related data will be collected systematically into a university provided and approved common electronic database (Research Electronic Data Capture, REDCap 10.6.9 2021 Vanderbilt University, Nashville, Tennessee, USA) at the University of Turku. Personal data and baseline characteristics will be recorded in REDCap. Subject withdrawal/replacement If any health conditions listed in the exclusion criteria are identified either prior to the procedure or during the follow-up period, the participant's involvement in the study may need to be discontinued. Participants have the right to withdraw from the study at any time, without providing a reason. Withdrawal of consent will not result in any negative consequences for the participant and will not affect their status as a healthcare client. Data collected up to the point of withdrawal will be used as part of the study material and for safety assessments. Randomisation and blinding Randomisation will be done with SAS (SAS 9.4, SAS Institute, Cary, North Carolina, USA) and will be performed using permuted blocks into two groups: * Group 1: Intracapsular tonsillectomy with coblator (ICTE). * Group 2: Extracapsular tonsillectomy with monopolar (ECTE). Randomisation will be carried out by the operating surgeon using the REDCap randomisation module, either on the morning of surgery or the day before. Allocation will be computer-generated in a 1:1 ratio, assigning participants to either intracapsular coblation tonsillectomy or extracapsular monopolar tonsillectomy. The surgeon will be informed of the assigned group, while participants will remain blinded to the allocation. The operation will be recorded in the medical records as "Tonsil surgery" without a definition of the technique. Bleeding and adverse events will be recorded as usual. The participant will remain unaware of their group assignment until the 5 years follow-up. In an emergency situation the assignment can be unblinded earlier if needed. In case of a serious adverse event, Suspected Unexpected Serious Adverse Event (SUSAR) form will be filled in. All statistical analyses will be performed by a professional statistician. Intervention In the FINITE-2 trial the treatment arms will be extracapsular tonsillectomy vs intracapsular tonsillectomy. * Surgery will be performed under general anesthesia by experienced otorhinolaryngologist who are familiar with both techniques (at least over 20 procedures done by both techniques). * The extracapsular tonsillectomy will be performed using monopolar diathermy unit with 15-25-Watts power with a pen electrode and a blunt-needle tip. * Using a pen electrode, the anterior palatinal arch is incised through, identifying the correct dissection plane between the tonsillar capsule and the pharyngeal muscle layer and the entire tonsil is removed. * NaCl moistened gaze sponges are placed into the tonsillar fossa. * Hemostasis is achieved with the same settings using pinpoint cautery. * If needed, gaze sponges soaked in Adrenaline 1 mg/ml can be used. * The intracapsular tonsillectomy will be performed by coblation wand ('Procise EZ' or other) Coblator II base unit, Smith \& Nephew plc, Watford, UK). Power settings will be set to default "7/3 coblation" and may be adjusted if needed. * Approximately 90% of the tonsil tissue is removed and the tonsil capsule will not be breached. * NaCl moistened gaze sponges are placed into the tonsillar fossa. * Haemostasis is primarily achieved by compression with NaCl moistened round gaze sponges. * If needed "coagulation" mode of the coblation instrument can be used for the haemostasis. * If needed, gaze sponges soaked in Adrenaline 1 mg/ml can be used. The postoperative analgesic treatment will be divided into three steps: Step 1: Ibuprofen 600 mg x 3 and paracetamol 500mg x 3 daily. If that is insufficient patients are advised to proceed to the next step. Step 2: Ibuprofen 600 mg x 4 and paracetamol 1000mg x 3 daily. If this is still not enough the rescue analgesia (step 3) is recommended. Step 3: Step 2 analgesics and the combination product of oxycodone 5mg + naloxone 2.5mg (Targiniq) x 1-4 daily. Participant timeline and follow-up Randomisation into extracapsular and intracapsular tonsillectomy group will be done before surgery. All the patients will be prescribed 10 days sick leave after surgery and if needed extension up to 14 days can be given by phone call to Turku University ENT department, open 24/7. Our study coordinator will call the study patients on day 7 after the surgery and asks standardized questions about sick leave duration and a standardized report form will be filled in. After 1 month the patients will be sent an e-mail survey via RedCap and asked if 10 days sick leave was enough, how long should the sick leave have been and what was the duration of absence from work eventually after surgery using a standardized report form. Patients will fill in the TOI-14 questionnaire at baseline, and at 12, 24 and 60 months after surgery. Post operative pain and the use of analgesics will be recorded by using Brief Pain Inventory questionnaire (BPI) on days 0-14 after surgery. Nordic Tonsil Surgery Register will be filled in by the patients at 1, 12, 24 and 60 months after surgery. Assessments Sick leave duration: Phone interview at 7 days and 1 month survey by RedCap. The post-operative pain, medication and recovery: Brief Pain Inventory (BPI) days 1-14 post-operative. Safety, complications: Nordic Tonsil Surgery Register (NTSR) 1 month post-operative Efficacy: Tonsillectomy Outcome Inventory-14 (TOI-14) at pre-operative and 12, 24 and 60 months post-operative. Glasgow Benefit Inventory (GBI) at 12 months post-operative Quality of Life: TOI-14 at pre-operative and 12, 24 and, 60 months post-operative. Glasgow Benefit Inventory (GBI) at 12 months post-operative, NTSR at 12-, 24- and 60-months post-operative. Adverse events Adverse events are defined as any undesirable event during the clinical trial. All adverse events reported by the study patients or observed by the investigators are recorded in the medical records. Study participants will receive the standard tonsillectomy postoperative care instructions currently in use. Recovery following tonsillectomy is often associated with nausea, painful recovery, and postoperative bleeding in 5-10% of cases. The prescribed pain medication may occasionally prove insufficient. These possible and common adverse effects will be monitored primarily through the Nordic Tonsil Surgery Register (1-month) questionnaire completed 30 days after surgery. The severity and causal relationship of adverse effects will be assessed using entries in the patient's medical records. Statistical Methods The primary hypothesis is that sick leave after ICTE is 3 days shorter than after ECTE. And ICTE is non-inferior to ECTE when comparing TOI-14 scores 12 months postoperatively. The sample size was calculated based on previous studies. The primary variables are whether 10 days sick leave is enough, yes/no and whether ICTE in non-inferior to ECTE according to TOI-14 scores 12 month after surgery. The analysis is based on a non-inferiority design, assuming ICTE is not worse than ECTE by more than a pre-specified margin. Baseline Assumptions: 10 days of sick leave is enough for 80% of the study patients undergoing ICTE and for 50% undergoing ECTE. ICTE is non-inferior to ECTE. Clinically significant difference: Clinically relevant group difference of 3 days of sick leave. Non-inferiority is defined as a between-group difference of less than 10 TOI-points 12 months post operatively. Statistical Parameters: Groups to compare: Two (ECTE, ICTE) Significance level: 5%. Power: 80%. Sample Size Adjustment for Dropouts: For the non-inferiority test, one-sided significance level of 2.5%, a statistical power of 90%, and a non-inferiority margin of 10 is used. Accounting for an anticipated 10% dropout rate, the sample size per group is adjusted to n = 45, with a total recruitment target of 90 participants. Planned Measurement Methods and Statistical Analyses The statistical analyses will be conducted following the completion of the study, with the dataset compiled by the principal investigator and analyzed by a designated biostatistician. Study groups will remain blinded until the final interpretation of the results. Analysis Populations The variables listed in Table 1, along with the background information of the recruited participants, will be presented using descriptive methods in two groups. Differences between the groups will be assessed using Student's t-test for continuous variables and Pearson's chi-square test for categorical variables, as well as their non-parametric counterparts if necessary. The normality of the variable distributions will be evaluated using Kolmogorov-Smirnov or Shapiro-Wilk test. In addition, a generalized linear model from the exponential family will be fitted to the primary outcome variable; is 10 days sick leave enough, as well as to each secondary variable, in order to explore interactions between multiple variables across groups. The model fit will be evaluated by examining the distribution of the residuals. Presentation of Results All baseline and background comparisons will be reported with standard deviations and p-values. All statistical model results will be reported with 95% confidence intervals and p-values. Illustrative figures will be drawn for relevant results. The significance level will be 5%, adjusted based on the number of comparisons conducted. Software All statistical analyses will be performed using R software (version 3.5.0 or newer). Data blinding will remain intact until the final statistical analyses and reporting. Documentation and data protection Data will be recorded in online database using REDCap platform (University of Turku) and on the servers of The wellbeing services county of Southwest Finland (VARHA). All data will be managed confidentially, and the information in the datasets is pseudonymised. Data are gathered from the out-patient clinical visits before and after the surgery, during the hospital stay, from the phone interviews and from questionnaires filled in by the study patients. The research coordinators will monitor the proper completion of questionnaires. The electronic system (REDCap) will send automated reminders, and follow-up phone calls are made if necessary. The research coordinators will systematically validate data quality on a monthly basis, collaborating with the principal investigator when required. The protocol authors will be responsible of the common database with full access to the data. Online database will not be used for other purposes during the trial. Original data will be stored on servers managed by the University of Turku and The wellbeing services county of Southwest Finland (VARHA) Finland for 20 years. Access to the research data is restricted to the named members of the research team. The data will not be archived unless a justified public interest arises. The principal investigator is responsible for data deletion or archiving decisions.