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.

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. - Cost-effectiveness study on Provox®2 and Groningen ULR prostheses

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON29968

Enrollment

Registered

2006-10-27

Start date

2007-02-12

Completion date

Unknown

Last updated

2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Larynx carcinoma layngeal cancer

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Lifetime of both types of TE shunt prosthesis	—

Secondary

Measure	Time frame
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.	—

Countries

Netherlands

Outcome results