Cost-effectiveness study on the Provox®2 and the Groningen Ultra Low Resistance tracheoesophageal shunt prostheses.

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.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON22831

Enrollment

Registered

2006-10-03

Start date

2006-11-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

None listed

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 leas

Eligibility

Inclusion criteria

Inclusion criteria: Patients from our outpatient clinic (ENT, UMCG): post-laryngectomees that use a TE shunt prosthesis for their phonation.

Exclusion criteria

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

Design outcomes

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.	—

Primary

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

Contacts

Public ContactK. Harms

University Medical Center Groningen (UMCG), Department of Ear- Nose and Throat (ENT), P.O. Box 30001

k.harms@kno.umcg.nl

Outcome results