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CO2-lasertonsillotomy versus tonsillectomy in adult patients; a multicenter randomized controlled trial

CO2-lasertonsillotomy versus tonsillectomy in adult patients; a multicenter randomized controlled trial - TOMTOM-study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON50550
Enrollment
198
Registered
2016-09-06
Start date
2018-01-22
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

tonsilrelated diseases

Interventions

One group will undergo CO2-lasertonsillotomy, the other group will undergo a classical tonsillectomy. Study treatment The CO2-lasertonsillotomies will be performed in our outpatient department whic

Sponsors

HagaZiekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - age > 18 years - tonsilrelated complaints with an indication for intervention (chronic/rec. tonsillitis, tonsillolithiasis, halitosis, dysphagia, OSAS (tonsilrelated))

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
- Number of days after the intervention until resumption of daily activities

Secondary

MeasureTime frame
- Presence or absence of tonsil related complaint - Number of tonsillitis episodes per year objectified by their general practitioner or ENT specialist - Number of antibiotic treatment regimens required for tonsillitis (per year) - Average number of sick days due to the tonsil-related complaints (per year) - Pain during / after the procedure (using VAS score) - Duration of the procedure - Resumption of daily activities (return to work / school resumption) - Complications (short and long term) - Patient satisfaction

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Aug 9, 2026