Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
ABR NL12933.042.06
Study information
Scientific title
Acronym
Study hypothesis
Hypothesis 1: the Groningen Ultra Low Resistance (ULR) and the Provox®2 are the same in terms of the replacement method, the burden on the patient and the convenience of the replacement and of the resistance during phonation.
Hypothesis 2: the Groningen ULR has a longer lifetime than the Provox®2 and is thus less expensive in use.
Hypothesis 3: the quality of life of the patient is higher while using the Groningen ULR than when using the Provox®2.
Ethics approval
Ethics approval received from the local medical ethics committee
Study design
Prospective randomised, controlled, crossover group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Tracheoesophageal shunt prostheses
Intervention
Prospective randomised cross-over design with a group of 80 patients aged 45 to 70 out of our population of over 134 post laryngectomy patients that have been using a TracheoEsophageal Shunt Prostheses (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
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Lifetime of both types of TE shunt prosthesis
Secondary outcome measures
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.
Overall trial start date
01/11/2006
Overall trial end date
10/04/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients from our outpatient clinic (Ear, Nose and Throat [ENT] Department at University Medical Centre Groningen [UMCG]): post-laryngectomees that use a TracheoEsophageal (TE) shunt prosthesis for their phonation.
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
80
Participant 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
Recruitment start date
01/11/2006
Recruitment end date
10/04/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
University Medical Center Groningen (UMCG)
Groningen
9700 RB
Netherlands
Sponsor information
Organisation
University Medical Center Groningen (UMCG) (The Netherlands)
Sponsor details
c/o Dr. B. van der Laan
Head of Department of Ear
Nose and Throat Medicine
P.O. Box 30001
Groningen
9700 RB
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Not defined
Funder name
Not provided at time of registration
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list