No registrations found.
ID
Source
Brief title
Health condition
tonsillitis, tonsillolithiasis, halitosis, dysphagia, OSAS (tonsilrelated),
chronisch/recidiverende tonsillitiden, tonsillolithiasis, halitosis, dysfagie, OSAS (tonsilgerelateerd)
Sponsors and support
LUMC
Viecuri
HMC
ZGT
RdG
MCL
JBZ
Gelderse Vallei
WZA
Amphia
Flevoziekenhuis
Intervention
Outcome measures
Primary outcome
Number of postoperative recovery days until resumption of daily activities.
Secondary outcome
• Presence or absence of tonsil related complaint(s)
• Number of tonsillitis episodes per year
• Number of antibiotic treatment regimens required for tonsillitis (per year)
• Average number of sick days due to the tonsilrelated complaints (per year)
• Pain during / after the procedure (using VAS score)
• Duration of the procedure
• Patient satisfaction regarding the intervention and reduction of tonsilrelated complaints
• Resumption of daily activities (return to work / school resumption)
• Number of days absence from work / school
• Complications (short and long term)
• Budget impact of CO2-lasertonsillotomy versus cold dissection tonsillectomy
• Cost effectiveness (analysis) of CO2-lasertonsillotomy versus cold dissection tonsillectomy
Background summary
When conservative treatment fails in patients with tonsil related complaints, a tonsillectomy using the classical dissection technique can be performed.
In adults substantial morbidity following classical tonsillectomy under general anesthesia has been reported. An interesting alternative treatment for a specific selection of adult patients could be the CO2 lasertonsillotomy
under local anesthesia in an outpatient clinical setting.
Several articles describe good treatment results and a decrease in perioperative and postoperative morbidity.
Our hypothesis is that CO2 lasertonsillotomy under local anesthesia is followed by a significantly shorter recovery period, that it is an effective treatment for tonsil related complaints and that it has better secondary outcome results compared to classical tonsillotomy
Study objective
Our hypothesis is that CO2 lasertonsillotomy under local anesthesia is followed by a significantly shorter recovery period, that it is an effective treatment for tonsil related complaints and that it has better secondary outcome results compared to classical tonsillotomy.
Study design
- pre-intervention
- 2 weeks post-intervention
- 6 weeks post-intervention
- 6 monts post-intervention
- 1 year post-intervention
- 2 year post-intervention
Intervention
- CO2-lasertonsillotomy under local anesthesia
- Cold dissection tonsillectomy
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
- history of peritonsillar abcess
- Friedman grade IV tonsils
- immunocompromised
- hemorrhagic diathesis / use of anticoagulants
- history of allergic reaction to local anesthetics
- in case of significant contra-indication for narcosis
- pregnancy
- extreme gag-reflex
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6866 |
| NTR-old | NTR7044 |
| CCMO | NL57496.098.16 |
| OMON | NL-OMON50550 |