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

When conservative treatment fail in patients with tonsil related complaints, a
tonsillectomy using the classical dissection technique van be performed. In
adults substantial morbidity is reported following classical tonsillectomy
under general anesthesia. An interesting alternative treatment for a specific
selection of adult patients could be the CO2-lasertonsillotomy under local
anethesia 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 effective and there are better
secondairy outcome results.

The purpose of this study is to demonstrate the effectiveness of treatment
using the CO2-laser in one selected group of patients compared with a classical
tonsillectomy. We also compare peri-operative en post-operative morbidity,
pain, complications and patient satisfaction.

Unblinded randomnised controlled trial. The patient will tickets for a classic
or a CO2 lasertonsillotomie tonsillectomy after informed consent. The draw will
be done using a block-randomization in every participating hospital. That means
that in each hospital closed envelopes will be used in which the treatment the
patient will undergo is documentated. In every hospital 50% of the cases will
recieve a traditional surgery and 50% a laser treatment. This ensures that the
two treatments will be equally divided after inclusion of all hospitals,
regardless of the number of patients in each participating hospital. We want a
to demonstrate a difference in the percentage of patients free of symptoms
between the two treatment groups of 80% vs 90%. With a power of 80% and a
2-sided alpha of 5%, there are 196 patients needed in both treatment groups. We
will take into account a loss of approximately 20%. Therefore we want a total
of 235 patients per group included.
We expect in the secondary outcomes greater differences between the two
treatment groups. The number of these patients to demonstrate greater
differences will certainly be sufficent.

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
the criteria for performing laser treatments. Patient will be instructed to
take 1000 mg Paracetamol one hour prior to the procedure. Both the physician
and the patient were safety laser goggles and outside the room a warning lamp
is clearly visible while the laser is in operation.
The patient is half lying. Subsequently, the superior, lateral and anterior
parts of the tonsillar pillars will be infiltrated bilaterally with Xylocaine
2% and Adrenaline 1: 80,000. The F125 laser tube by Lumenis will be used with
the laser in the continuous wave mode of operation and a beam diameter of 3 mm.
Depending on the tonsil size, the power can be raised to 29 watts. With a
tongue blade the tonsil will be presented and the tonsil surface is evaporated
in a continuous sweeping motion. This act repeated layer by layer until a total
cryptolysis occurred. The patient is instructed to hold his breath during
activation of the laser and to exhale slowly after deactivation, to avoid
inhaling the resulting smoke. On average a patient can hold his breath for 45
seconds (range 8-98 seconds). During the procedure the resulting smoke was
continuously aspirated using a smoke evacuator. When a persistent local
bleeding emerged, bipolar coagulation was used.

Control treatment
The classical tonsillectomy will be planned in daycare or short clinical stay
wich is possible in all participating centra. Before the operation patients get
a peripheral infuse. In the operation room the patient recieves general
anesthesia. The patient is placed in supine position after which the patient is
intubated. The mouth is opened using a mouth gag. An Alyss clip wil be attached
to the superior pole of the tonsil. Then 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 to the base of the tonsil. The space can be enlarged using scissors if
necessary. Using a tonsil pliers the tonsil will be removed. Gauze are used to
stop the bleeding. After 5 minutes we remove the guazes and check whether the
wound is dry and, if necessary bleeding can be coagulated. The mouth gag is
removed if the wound is dry. After surgery, the patient will be transported to
the recovery and then to the day care unit . The anaesthesiologist will decide
on post-operative pain medication / anti-emetics if necessary.

Complications laser treatment:
- About 10% is not free of complaints and has so many complaints that they get
a classical tonsillectomy after laser treatment
- In total, approximately 22% of patients undergo more than 1 laser treatment
- Wound infection
- 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
- General anesthesia complications