Prospective study on cost-effectiveness of the Provox®2 and the Groningen Ultra Low Resistance tracheoesophageal shunt prostheses in voice rehabilitation of post-laryngectomy patients.

Some of the patients with laryngeal cancer have to be treated with a total
laryngectomy. During this procedure the whole larynx is taken out of the
patient which means that after surgery speech rehabilitation will be necessary.
In this rehabilitation a tracheo-esophageal shunt prosthesis (TESP) is used
which is placed in a shunt between the trachea and the esophagus that is formed
during the total laryngectomy. This TESP is made of silicone rubber and has a
valve mechanism that can only be opened in the direction of the esophagus. This
opening happens when air is pushed from the trachea through the prosthesis into
the esophagus while closing the tracheostoma with a thumb or finger. With this
air sound is produced. In the Netherlands and the rest of Europe the Provox®2
and the Groningen Ultra Low Resistance (ULR) TESPs are most frequently used.
Both have a limited lifetime and have to be replaced on a regular basis. The
lifetime of the TESP varies between patients, per worn prosthesis and between
types of TESPs. This was studied in a pilot (n=22) in our clinic: the mean
lifetime of the Groningen ULR was 1,5 times longer than the mean lifetime of
the Provox®2.
The burden on the patient of the replacement procedure is substantial. To
replace the TESP a patient needs to visit an ENT outpatient clinic that has
authorized personnel to perform the replacement. This means that numerous
expenses have to be made for travelling and time. This influences the quality
of life of the patient. Additionally the procedure itself can be very
uncomfortable and can induce pain, minor bleeding, cough and gag reflexes.
Many patients prefer the Provox®2 TESP. First this is because of the
replacement technique. The Provox®2 is anterogradely replaced through the
tracheostoma, a relatively easy procedure. The Groningen ULR was previously
replaced retrogradely through the mouth which was very uncomfortable for the
patient. Nowadays the Groningen ULR is also replaced anterogradely with the
*frontloading system*. A second reason why the Provox®2 was preferable is the
higher resistance during phonation with the older Groningen type TESP. However
the newer Groningen ULR has a speech resistance that is comparable to that of
the Provox®2.
The price of the Provox®2 is between 250-300 euros and that of the Groningen
ULR about 90-100 euros. The Provox®2 is also more expensive in use due to the
more frequent need for replacement.
Hypothesis 1: the Groningen ULR and the Provox®2 are the same in terms of the
replacement method, the burden on the patient and the convenience of the
replacement and of the resistance during phonation.
Hypothesis 2: the Groningen ULR has a longer lifetime than the Provox®2 and is
thus less expensive in use.
Hypothesis 3: the quality of life of the patient is higher while using the
Groningen ULR than when using the Provox®2.

The objective of the study is a prospective study to evaluate which type of TE
shunt prosthesis is the most cost-effective.

A prospective randomized cross-over design with a group of 80 patients aged
45-70 out of our population of over 134 post laryngectomy patients that have
been using a TESP for their phonation for at least six months. The patients are
randomly divided into four groups according to the following schedule:

Group N Baseline Interval 0 Interval 1 Interval 2
1 20 G/P G G G
2 20 G/P G G P
3 20 G/P P P G
4 20 G/P P P P


G= groningen ultra low resistance
P= Provox®2

In this way, individual differences and preferences can be found.

The burden on the patient exists from filling in the questionnaires on set
times during the two years of research. These questions are very non-invasive.
There is no higher risk for the patient because in the techniques used this
study are already standard techniques in our clinic and the rest of Europe.
The patient can quit the study at any time, for example if a patient is very
unhappy with the type of prosthesis used at one moment in the study, the
patient can change to the prosthesis of his or her choice at any time.