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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR788 |
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Date of registration:
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03/10/2006 |
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Primary sponsor: |
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Public title:
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Cost-effectiveness study on the Provox®2 and the Groningen Ultra Low Resistance tracheoesophageal shunt prostheses.
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Scientific title:
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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 |
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Date of first enrolment:
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1/11/2006 |
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Target sample size:
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80 |
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Recruitment status: |
recruiting |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=788 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: None; Control: Active; Group: Crossover; Type: -
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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K.
Harms |
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Address:
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University Medical Center Groningen (UMCG),
Department of Ear- Nose and Throat (ENT),
P.O. Box 30001
9700 RB
Groningen
The Netherlands |
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Telephone:
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Email:
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k.harms@kno.umcg.nl |
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Affiliation:
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Name:
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K.
Harms |
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Address:
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University Medical Center Groningen (UMCG),
Department of Ear- Nose and Throat (ENT),
P.O. Box 30001
9700 RB
Groningen
The Netherlands |
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Telephone:
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Email:
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k.harms@kno.umcg.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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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
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Tracheoesophageal shunt
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Intervention(s)
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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
P= Provox®2
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Primary Outcome(s)
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Lifetime of both types of TE shunt prosthesis
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Secondary Outcome(s)
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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.
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Secondary ID(s)
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ABR NL12933.042.06
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ISRCTN31438086
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Source(s) of Monetary Support
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None
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