Recovery From Tonsil Surgery.

NCT07598201 | Not Yet Recruiting DMC

• 2 other identifiers: T2025/11001VARHA/17462/13.02.02/2025
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Recurrent Tonsillitis; Chronic Tonsillitis

Keywords

intracapsular tonsillectomy; extracapsular tonsillectomy

Outcome Measures

Primary Outcomes (2)

• 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

  From intervention to the survey at 1 month

• 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).

  From intervention to 12 month follow-up

Secondary Outcomes (7)

• Whether a 7-day sick leave is sufficient after intracapsular and extracapsular tonsillectomy

  From intervention to 30 days follow-up

• Pain interference

  from intervention to 2 weeks

• Return to normal diet.

  From intervention, 1-14 days post-operatively

• 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.

  days 1-14 post op

• The quality of life

  12 months post-operative up to 60 months follow-up

Study Arms (2)

intracapsular tonsillectomy

ACTIVE COMPARATOR

partial tonsillectomy

Procedure: intracapsular tonsillectomy

extracapsular tonsillectomy

ACTIVE COMPARATOR

classical tonsillectomy

Procedure: extracapsular tonsillectomy

Interventions

extracapsular tonsillectomy PROCEDURE

classical tonsillectomy

extracapsular tonsillectomy

intracapsular tonsillectomy PROCEDURE

partial tonsil surgery

intracapsular tonsillectomy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65 years
• Recurrent or chronic tonsillitis (see above)
• Indication for surgical treatment
• Eligible for day care surgery

You may not qualify if:

• 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
• Contraindication to non-steroidal anti-inflammatory drugs (NSAID) or paracetamol
• Other significant co-morbidity
• Other contraindications determined by the investigator

Sponsors & Collaborators

• Turku University Hospital: lead

MeSH Terms

Conditions

Tonsillitis

Condition Hierarchy (Ancestors)

Pharyngitis; Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Study Officials

• Lotta E Ivaska, PhD

  Turku University Hospital and University of Turku

  PRINCIPAL INVESTIGATOR

• Jaakko M Piitulainen, PhD

  Turku University Hospital and University of Turku

  STUDY DIRECTOR

Central Study Contacts

Lotta E Ivaska, PhD, MD

CONTACT

+358400383900; lesaar@utu.fi

Jaakko M Piitulainen, PhD, MD

CONTACT

jaakko.piitulainen@utu.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: May 20, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): December 1, 2030
• Last Updated: May 20, 2026

Record last verified: 2025-12