Condition category
Ear, Nose and Throat
Date applied
28/12/2006
Date assigned
28/12/2006
Last edited
29/12/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr K Harms

ORCID ID

Contact details

University Medical Center Groningen (UMCG)
Deparment of ENT
P.O. Box 30001
Groningen
9700 RB
Netherlands

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 measures

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

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

http://www.rug.nl/umcg/index?lang=en

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes