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Conventional tonsillectomy versus outpatient CO2-lasertonsillotomy in adult patients; a randomised controlled trial

Conventional tonsillectomy versus outpatient CO2-lasertonsillotomy in adult patients; a randomised controlled trial - SMOKE protocol

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON35754
Enrollment
470
Registered
2011-07-29
Start date
2011-11-01
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

recurrent tonsillitis tonsil related complaints

Interventions

One group will undergo CO2-lasertonsillotomy, the other group will undergo a classical tonsillectomy. Study treament The CO2-lasertonsillotomies take place in our outpatient department that met th

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, hallitosis)

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 tonsilsize and cooperation) - immunocompromised - hemorrhagic diathesis - cardiac history

Design outcomes

Primary

MeasureTime frame
Presence or absence of the complaints which the patient has undergone surgery (chronic / recurrent tonsillitis, tonsillolithiasis, hallitosis). - Number of tonsillitis episodes per year objectified by their GP or ENT specialist - Number of antibiotics associated with tonsillitis per year - Average number of sick days per year due to the tonsil-related complaints - Presence / absence of hallitosis - Presence / absence of tonsillolithiasis

Secondary

MeasureTime frame
- 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)