Cost-effectiveness study on the provox®2 and the Groningen ultra low resistance tracheoesophageal shunt prostheses
| ISRCTN | ISRCTN31438086 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31438086 |
| Secondary identifying numbers | ABR NL12933.042.06, NL777, NTR788 |
- Submission date
- 28/12/2006
- Registration date
- 28/12/2006
- Last edited
- 06/01/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Ear, Nose and Throat
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr K Harms
Scientific
Scientific
University Medical Center Groningen (UMCG)
Deparment of ENT
P.O. Box 30001
Groningen
9700 RB
Netherlands
Study information
| Study design | Prospective randomised, controlled, crossover group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | Cost-effectiveness study on the provox®2 and the Groningen ultra low resistance tracheoesophageal shunt prostheses |
| Study objectives | 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(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Tracheoesophageal shunt prostheses following laryngectomy |
| 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 |
| 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 study start date | 01/11/2006 |
| Completion date | 10/04/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | 80 |
| Total final enrolment | 80 |
| Key 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. |
| Key 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 |
| Date of first enrolment | 01/11/2006 |
| Date of final enrolment | 10/04/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Medical Center Groningen (UMCG)
Groningen
9700 RB
Netherlands
9700 RB
Netherlands
Sponsor information
University Medical Center Groningen (UMCG) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
c/o Dr. B. van der Laan
Head of Department of Ear, Nose and Throat Medicine
P.O. Box 30001
Groningen
9700 RB
Netherlands
| Website | http://www.rug.nl/umcg/index?lang=en |
|---|---|
"ROR" |
https://ror.org/03cv38k47 |
Funders
Funder type
Not defined
Not provided at time of registration
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2011 | 06/01/2021 | Yes | No |
Editorial Notes
06/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
3. The NTR numbers have been added.
