The aim of this study is to investigate the long-term outcomes in patients with BWS that have been surgically treated at our institution with the help of simple, non-invasive, objective study tools. We hope to gain valuable information regarding the…
ID
Source
Brief title
TASTE-study
Condition
- Congenital and hereditary disorders NEC
- Head and neck therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
In total, all participants will visit the outpatient clinic of our craniofacial
research unit one single time to complete the study. Differences in the outcome
of the taste test, the speech assessment test and the evaluation of the
oro-facial development between the study group and the none-operated control
group will be evaluated.
Secondary outcome
Niet van toepassing
Background summary
Reports on the long-term functional outcomes of surgical tongue reduction in
patients with Beckwith Wiedemann Syndrome are sparse and show various results.
The evaluation of tongue function after tongue reduction surgery has been
mainly subjective in previously published reports. The major difficulties when
investigating the long-term functional outcomes after tongue reduction surgery
remain the small number of treated patients and the need of validated tests for
correct assessment of tongue function and taste.
Study objective
The aim of this study is to investigate the long-term outcomes in patients with
BWS that have been surgically treated at our institution with the help of
simple, non-invasive, objective study tools. We hope to gain valuable
information regarding the benefits and possible disadvantages following tongue
surgery, and to create a basis for further research investigating the surgical
treatment options of macroglossia in Beckwith Wiedemann Syndrome.
Study design
A retrospective observational case-control follow-up study.
Study burden and risks
Participants will visit the outpatient clinic of our craniofacial research unit
one single time. The risks are negligible and the burden minimal. We will be
obliged to include minors as participants in our study since BWS is an uncommon
disorder with a consequent limited number of potential participating patients.
Meibergdreef 9
1105 AZ Amsterdam
NL
Meibergdreef 9
1105 AZ Amsterdam
NL
Listed location countries
Age
Inclusion criteria
- Written informed consent
- History of macroglossia
- Patients included in the control group have been diagnosed with BWS and were not treated for macroglossia
- 5 years <= age <= 20 years on the day of participation
- History of good physical and mental health as determined by history taking.
Exclusion criteria
- Serious mental impairment
- History or presence of a medical condition that can influence speech, such as cleft palate, hearing problems or other problems that can potentially cause a developmental delay
- History or presence of a medical condition that can potentially influence taste perception
- History or presence of a medical condition that can potentially influence normal oro-facial development
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL35313.018.11 |