|- candidate number||2278|
|- NTR Number||NTR788|
|- Date ISRCTN created||28-dec-2006|
|- date ISRCTN requested||18-dec-2006|
|- Date Registered NTR||3-okt-2006|
|- Secondary IDs||ABR NL12933.042.06 |
|- Public Title||Cost-effectiveness study on the Provox®2 and the Groningen Ultra Low Resistance tracheoesophageal shunt prostheses.|
|- Scientific Title||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.|
|- ACRONYM||Cost-effectiveness study on Provox®2 and Groningen ULR prostheses|
|- hypothesis||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.
|- Healt Condition(s) or Problem(s) studied||Tracheoesophageal shunt|
|- Inclusion criteria||Patients from our outpatient clinic (ENT, UMCG): post-laryngectomees that use a TE shunt prosthesis for their phonation.
|- Exclusion criteria||1. Patients younger than 45 or older than 70.|
2. Patients that have a metastasis or recurrence of their previous larynx carcinoma.
3. Patients that smoke tobacco
|- mec approval received||yes|
|- multicenter trial||no|
|- planned startdate ||1-nov-2006|
|- planned closingdate||10-apr-2008|
|- Target number of participants||80|
|- Interventions||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 1, 20 persons: G-G-G
Group 2, 20 persons: G-G-P
Group 3, 20 persons: P-P-G
Group 4, 20 persons: P-P-P
G= groningen ultra low resistance
|- Primary outcome||Lifetime of both types of TE shunt prosthesis |
|- Secondary outcome||1. Total costs for the use of both the Provox®2 and Groningen ULR TE shunt prostheses. An incremental cost analysis.|
2. Quality of life
3. Evaluation of both types of prostheses
4. Preference of patients for one of both types of prostheses.
5. Experience with replacement and -technique.
6. Diet. Food products that influence lifetime of the TE shunt prosthesis
7. Expenses made by patient.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Drs. K. Harms|
|- CONTACT for SCIENTIFIC QUERIES||Drs. K. Harms|
|- Sponsor/Initiator ||University Medical Center Groningen (UMCG), Department of Ear, Nose and Throat medicine|
(Source(s) of Monetary or Material Support)
|- Brief summary||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.|
|- Main changes (audit trail)|
|- RECORD||3-okt-2006 - 29-dec-2006|