Cost-effectiveness study on the Provox®2 and the Groningen Ultra Low Resistance tracheoesophageal shunt prostheses.
Recruiting
- Registration Number
- NL-OMON22831
- Lead Sponsor
- Dr. B.F.A.M. van der LaanHead of department of Ear, Nose and Throat medicine University Medical Centre Groningen
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 80
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ifetime of both types of TE shunt prosthesis
- Secondary Outcome Measures
Name Time Method 1. Total costs for the use of both the Provox®2 and Groningen ULR TE shunt prostheses. An incremental cost analysis.<br /><br>2. Quality of life<br /><br>3. Evaluation of both types of prostheses<br /><br>4. Preference of patients for one of both types of prostheses.<br /><br>5. Experience with replacement and -technique.<br /><br>6. Diet. Food products that influence lifetime of the TE shunt prosthesis<br /><br>7. Expenses made by patient.<br />