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.
Recruiting
- Conditions
- Larynx carcinomalayngeal cancer1003866610029107
- Registration Number
- NL-OMON29968
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- 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. Patients have to have at least 6 months of experience with the use of the TE shunt prosthesis. Patient should be 45-70 years of age.
Exclusion Criteria
Patients that have a metastasis or recurrence of their previous larynx carcinoma.
Patients with less than 6 months of experience with the TE shunt prosthesis.
Patients younger than 45 or older than 70.
Patients that currently smoke tobacco.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Lifetime of both types of TE shunt prosthesis</p><br>
- Secondary Outcome Measures
Name Time Method <p>1. Total costs for the use of both the Provox®2 and Groningen ULR TE shunt<br /><br>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.</p><br>