Recovery From Tonsil Surgery.
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorTurku University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-65 years
Recurrent or chronic tonsillitis (see above)
Indication for surgical treatment
Eligible for day care surgery
Disqualifiers
Peritonsillar abscess less than month ago
Previous palatine tonsil surgery (excluding small incision or biopsy)
Current or positive history of a malignant disease
Anticoagulant medication
Trial design
Design model
Parallel
Treatments tested in this trial
extracapsular tonsillectomy
Procedure/Surgeryclassical tonsillectomy
intracapsular tonsillectomy
Procedure/Surgerypartial tonsil surgery
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: intracapsular tonsillectomyActive comparator 1 intervention
Group B: extracapsular tonsillectomyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Is 10-day sick leave sufficient following intracapsular and extracapsular tonsillectomy
(yes/no, dichotomous variable). Proportion of the patients for whom it is enough. 3 days difference between groups is clinically significant
Time frame
From intervention to the survey at 1 month2
Is to assess whether ICTE is non-inferior to ECTE, with ECTE serving as the control.
The analysis is based on a non-inferiority design using 12 months post operative TOI-14 scores, assuming ICTE is not worse than ECTE. Less than 10 points difference between groups is assumed and minimum important change in both groups pre-operative-\> post-operative is 10 points. The total score can range between 0 (no problems) and 100 (most severe problems).
Time frame
From intervention to 12 month follow-upSecondary outcomes
1
Whether a 7-day sick leave is sufficient after intracapsular and extracapsular tonsillectomy
yes/no, dichotomous variable). The proportion of patients for whom it is enough.
Time frame
From intervention to 30 days follow-up2
Pain interference
measured with Brief Pain Inventory, Visual Analogue Scale (VAS 0-10, 0=no pain, 10=worst pain)
Time frame
from intervention to 2 weeks3
Return to normal diet.
Mean pain interference, Visual Analogue Scale (VAS 0-10), proportion with score \<4 during postoperative days 1-14
Time frame
From intervention, 1-14 days post-operatively4
The adequacy of NSAID and paracetamol alone (steps 1 and 2) for pain management after intracapsular tonsillectomy, or whether rescue analgesia with opioids (step 3) is required.
Proportion of the patients needing rescue analgesia, compared between groups.
Time frame
days 1-14 post opLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: