Tonsillitis RecurrentNCT04657549
Tonsil Surgery in Recurrent or Chronic Tonsillitis
A study testing Tonsillectomy and Tonsillotomy in people with Tonsillitis Recurrent and Tonsillitis Chronic, run by Oulu University Hospital at 7 sites in Finland.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tonsillitis Recurrent, Tonsillitis Chronic
- What is being tested?
- Tonsillectomy and Tonsillotomy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 7 sitesFinland
- Study dates
- 8 Dec 2020to 9 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Finland7 sites
Länsi-Pohja Central Hospital
Kemi, FIN-94100
Keski-Pohjanmaa Central Hospital
Kokkola, FIN-67200
Oulu University Hospital
Oulu, FIN-90029
Lapland Central Hospital
Rovaniemi, Lapland, FIN-96400
Seinäjoki Central Hospital
Seinäjoki, FIN-60220
Turun yliopistollinen keskussairaala
Turku
Vaasan keskussairaala
Vaasa
About this study
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.
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.
Read the 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.
- Conditions
- Tonsillitis Recurrent, Tonsillitis Chronic
- Being tested
- Tonsillectomy, Tonsillotomy
- Keywords
- tonsillitis, tonsillectomy, tonsillotomy, tonsil surgery
- Medical subject headings
- Tonsillitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TonsillectomyProcedure or surgery
Also called Extracapsular tonsillectomy, ECTE
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.
TonsillotomyProcedure or surgery
Also called Intracapsular tonsillectomy, ICTE. Subtotal/intracapsular/partial tonsillectomy, SIPT.
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.
| Study group | Role | What they receive |
|---|---|---|
| Tonsillectomy | Active comparator | Patients will undergo tonsillectomy under general anesthesia within three weeks after enrollment. Receives: Procedure: Tonsillectomy |
| Tonsillotomy | Active comparator | Patients will undergo tonsillotomy under general anesthesia within three weeks after enrollment. Receives: Procedure: Tonsillotomy |
| Watchful waiting | No intervention | Patients will be closely monitored for the 5-6 months monitoring period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: At the end of five to six months follow-up
Adverse effect-postoperative bleeding
Frequency of postoperative bleeding in the surgical groups
Measured: At the end of five to six months follow-up
Adverse effect - postoperative pain
Frequency of postoperative pain in the surgical groups
Measured: At the end of five to six months follow-up
Adverse effect - postoperative infection
Frequency of postoperative infections in the surgical groups
Measured: At the end of five to six months follow-up
Adverse effect - dental injury
Frequency of dental injury in the surgical groups
Measured: At the end of five to six months follow-up
Adverse effect -anesthetic complication
Frequency of anesthetic complication in the surgical groups
Measured: 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
Measured: At the end of five to six months follow-up
Adverse effect - voice problems
Difference in proportions having voice problems between the groups
Measured: At the end of five to six months follow-up
Adverse effect - jaw problems
Difference in proportions having mandibular joint problems between the groups
Measured: At the end of five to six months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2020
- Study start8 Dec 2020
- Primary completion9 Jun 2023
- Study completion9 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Tonsillitis RecurrentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oulu University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olli-Pekka Alho, MD, Oulu University Hospital
- Investigators
- Olli-Pekka Alho, MD, PhD, Principal investigator, Oulu University Hospital, University of OuluAleksi EJ Laajala, MD, Study chair, Oulu University Hospital, University of OuluPaulus Tokola, MD, Study chair, Oulu University Hospital, University of OuluTimo J Autio, MD, PhD, Study chair, Oulu University HospitalTimo J Koskenkorva, MD, PhD, Study chair, University of OuluPasi Ohtonen, M. Sc., Study chair, Division of Operative Care, Oulu University Hospital, FinlandEsa Läärä, PhD., Study chair, Oulu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04657549
- Sponsor's protocol ID
- Diary number 113/2020
- Status last verified
- Jun 2023
- First submitted
- 16 Nov 2020
- Last updated
- 12 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 32060601Koskenkorva 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.
PubMed 24863677Laajala 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.
PubMed 34526073
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04657549
- Acronym / sponsor ID
- Diary number 113/2020
- Conditions
- Tonsillitis Recurrent, Tonsillitis Chronic
- Keywords
- tonsillitis, tonsillectomy, tonsillotomy, tonsil surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Oulu University HospitalUniversity, hospital or other
- Study start
- 8 Dec 2020 (actual)
- Primary completion
- 9 Jun 2023 (actual)
- Study completion
- 9 Jun 2023 (actual)
- First posted
- 8 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tonsillectomy | Active comparator | Procedure: TonsillectomyPatients will undergo tonsillectomy under general anesthesia within three weeks after enrollment. |
| Tonsillotomy | Active comparator | Procedure: TonsillotomyPatients will undergo tonsillotomy under general anesthesia within three weeks after enrollment. |
| Watchful waiting | No intervention | –Patients will be closely monitored for the 5-6 months monitoring period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TonsillectomyAlso: Extracapsular tonsillectomy, ECTETonsillectomy 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. | Procedure or surgery | Tonsillectomy |
| TonsillotomyAlso: Intracapsular tonsillectomy, ICTE. Subtotal/intracapsular/partial tonsillectomy, SIPT.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. | Procedure or surgery | Tonsillotomy |
Primary outcome
Tonsillectomy Outcome Inventory -14 (TOI-14) follow-up score
Time frame: 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.
20 secondary outcomes
36-Item short Form Survey (SF-36, RAND-36) follow-up score
Time frame: At the end of five to six months follow-up
Proportion benefiting
Time frame: At the end of five to six months follow-up
Days with throat pain
Time frame: At the end of five to six months follow-up
Days with halitosis
Time frame: At the end of five to six months follow-up
Days with bleeding
Time frame: At the end of five to six months follow-up
Days with tonsil stones
Time frame: At the end of five to six months follow-up
Days with absence from work
Time frame: At the end of five to six months follow-up
Days with dexketoprofen
Time frame: At the end of five to six months follow-up
Days with acetaminophen
Time frame: At the end of five to six months follow-up
Days with oxycodone/naloxone
Time frame: At the end of five to six months follow-up
Medical visits
Time frame: At the end of five to six months follow-up
Antibiotic courses
Time frame: At the end of five to six months follow-up
Adverse effect-postoperative bleeding
Time frame: At the end of five to six months follow-up
Adverse effect - postoperative pain
Time frame: At the end of five to six months follow-up
Adverse effect - postoperative infection
Time frame: At the end of five to six months follow-up
Adverse effect - dental injury
Time frame: At the end of five to six months follow-up
Adverse effect -anesthetic complication
Time frame: At the end of five to six months follow-up
Adverse effect - tightness/globus
Time frame: At the end of five to six months follow-up
Adverse effect - voice problems
Time frame: At the end of five to six months follow-up
Adverse effect - jaw problems
Time frame: At the end of five to six months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2023.
- Background: PubMed 32060601Laajala 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.
- Background: PubMed 24863677Koskenkorva 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.
- Background: PubMed 34526073Laajala 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olli-Pekka Alho, MD, PhD principal investigator
Oulu University Hospital, University of Oulu
Aleksi EJ Laajala, MD study chair
Oulu University Hospital, University of Oulu
Paulus Tokola, MD study chair
Oulu University Hospital, University of Oulu
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tonsillectomy and Tonsillotomy in people with Tonsillitis Recurrent and Tonsillitis Chronic, run by Oulu University Hospital at 7 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tonsillectomy Outcome Inventory -14 (TOI-14) follow-up score (time frame: At the end of five to six months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04657549, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2023.