CO2-lasertonsillotomy versus tonsillectomy in adult patients; a multicenter randomized controlled trial
Completed
- Conditions
- tonsilrelated diseases10038737
- Registration Number
- NL-OMON50550
- Lead Sponsor
- HagaZiekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 198
Inclusion Criteria
- age > 18 years
- tonsilrelated complaints with an indication for intervention
(chronic/rec. tonsillitis, tonsillolithiasis, halitosis, dysphagia, OSAS
(tonsilrelated))
Exclusion Criteria
- not cooperative / restless
- unable to open the mouth for a longer period
- presence of a strong gag reflex
- history of peritonsillar abcess
- estimated duration of treatment > 30 min (based on tonsil size and
cooperation)
- immunocompromised
- hemorrhagic diathesis
- cardiac history
- history of allergic reaction to local anesthetics
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- Number of days after the intervention until resumption of daily activities </p><br>
- Secondary Outcome Measures
Name Time Method <p>- Presence or absence of tonsil related complaint<br /><br>- Number of tonsillitis episodes per year objectified by their general<br /><br>practitioner or ENT specialist<br /><br>- Number of antibiotic treatment regimens required for tonsillitis (per year)<br /><br>- Average number of sick days due to the tonsil-related complaints (per year)<br /><br>- Pain during / after the procedure (using VAS score)<br /><br>- Duration of the procedure<br /><br>- Resumption of daily activities (return to work / school resumption)<br /><br>- Complications (short and long term)<br /><br>- Patient satisfaction </p><br>