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

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 post-operative
morbidity. Our hypothesis is that CO2-lasertonsillotomy is followed by a
significantly shorter recovery period, effective as treatment for tonsil
related complaints and has better secondary outcome results compared to,
classical tonsillectomy.

The purpose of this study is to evaluate the added value of CO2-laser
tonsillotomy for tonsil related diseases.

Open multicenter randomized controlled trial. The patient will randomly be
selected for either a classic tonsillectomy or a CO2-lasertonsillotomy. Per
hospital block-randomization will be used. We want to prove a difference in
days until resumption of daily activities of at least 3. The average recovery
time after tonsillectomy is 10 days (SD 5). With a power of 90% and a two sided
alpha of 5% we need 59 patients per treatment group. With a maximum expected
drop-out of 40% we need to include a total of 198 patients.
As the difference in secondary outcomes between both treatment-groups is
expected to be greater than the primary outcome, the previously calculated
number of patients should be sufficient for assessment of these outcomes as
well.

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
which meets the criteria for performing laser treatments. Patient will be
instructed to take 1000 mg paracetamol one hour prior to the procedure. The
superior, middle and lower part of the tonsil will be infiltrated bilaterally
with xylocaine 2% and adrenaline 1: 80,000. The CO2 laser will be equipped with
a F125 laser tube (Lumenis) and set in continuous wave mode with a 3mm laser
beam. Depending on tonsil-size, the power will be set to a maximum of 29 watts.
After presenting the tonsil with a tongue blade the surface of the tonsil will
be evaporated in a continuous sweeping motion repeatedly until total
cryptolysis has been accomplished and the tonsillar capsule has been reached.
The patient is instructed to take a deep breath before activation of the laser
and exhale slowly during the laser procedure to minimize doctor*s loss of
vision due to intra oral smoke accumulation. After deactivation of the laser
the patient should exhale residual breath before taking a first breath. During
the procedure there will be continuous suction of the smoke. When a persistent
local bleeding emerges, bipolar coagulation will be used.


Control treatment
The classical tonsillectomy will be planned in daycare or short clinical stay
in one of the participating centers. Before the operation patients get a drip.
In the operation room the patient receives general anesthesia. The patient is
placed in supine position after intubation. The mouth is opened using a mouth
gag. An Alyss clip will be attached to the superior pole of the tonsil after
which an incision is made through the anterior pillar of the tonsil to view the
underlying tonsillar capsule. The incision is made close to the anterior fold
and will be extended through the mucosa up to the base of the tonsil. Using a
tonsil plier the tonsil will be removed. Gauzes are used to stop the bleeding.
After 5 minutes the gauzes are removed and if necessary persistent bleeding
will be stopped using electro-coagulation. The anesthesiologist will decide on
post-operative pain medication / anti-emetics if necessary.

Complications of lasertonsillotomy
- 10% of patients is not free of primary complaint(s) and requires a subsequent
classical tonsillectomy
- In total, approximately 22% of patients undergo more than 1 laser treatment
- Wound infection (+- 3-4%)
- Bleeding for which intervention is required (<1%)
- Allergic reaction to local anesthetic
- Side effects of local anesthesia (xylocaine 2% / adrenaline 1:80.000) as
described in the leaflet

Complications classical tonsillectomy
- Bleeding for which intervention is required (+ - 1.4%)
- Wound infection (+- 2-5%)
- General anesthesia complications