To investigate the differences in facial analysis, between patients with acromegaly, being in remission, and healthy subjects, and to investigate the changes in relational proportions between these facial structures.
ID
Source
Brief title
Condition
- Other condition
- Hypothalamus and pituitary gland disorders
- Bone disorders (excl congenital and fractures)
Synonym
Health condition
weke delen van het gelaat
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The comparison of cephalometricand facial analyses of both 3D stereophotography
and 3D cone beam CT data in patients with acromegaly and healthy
subjects.Furthermore, the average face scan be computed based on the 3D
photographs acquired in this study. An average face will be computed for
acromegalic patients and healthy subjects. After computation, the average faces
can be compared to analyze the overall differences in facial differences
between both groups.
Secondary outcome
The following parameters will also be collected: sex, date of birth, length,
weight, oral/maxillofacial surgical treatment in the past, pre-operative IGF-1,
GH and oral glucose tolerance test, pituitary MRI results (micro/macro
adenoma), date of diagnosis, date of operation, post-operative IGF-1, GH and
oral glucose tolerance test, duration of follow-up, last IGF-1 result and
presence of hypopituitarism.
Background summary
Acromegaly is the clinical syndrome that results from an excess of the growth
hormone (GH) caused by GH producing pituitary adenoma. This can cause systemic
complications due to alterations of metabolism and somatic overgrowth.
Craniofacial disproportions due to soft tissue swelling and new bone formation
are highly prevalent in patients with acromegaly and are not fully reversible
after treatment. Besides the cosmetic aspects, these changes can impair the
quality of life because of the significant morbidity with respect to oral and
maxillofacial pathologies as well as respiratory problems such as sleep apnea
that they cause. Patients require careful work-up of oral and maxillofacial
examinations in collaboration with dentists and dental surgeons even long after
the acromegaly has been treated. Facial analysis, after achieving remission
through transsphenoidal pituitary surgery, can give information about the
persistent craniofacial disproportions. With the conventional diagnostic
examinations it is impossible to investigate all of the facial dimensions
together. The new 3D stereophotograph and skull reconstructed from CT data
fusion model allows to investigate the craniofacial changes due to acromegaly
in all facial dimensions (dentition, bone and soft tissue) together and the
relational proportions between these facial structures.
Study objective
To investigate the differences in facial analysis, between patients with
acromegaly, being in remission, and healthy subjects, and to investigate the
changes in relational proportions between these facial structures.
Study design
A single centre, observational, cross sectional, cohort study.
Study burden and risks
As a result of participating in this study, subjects have to undergo a single
3D fusion imaging, consisting of a 3Dstereophotograph and a 3D cone beam CT.
The cone beam CT is associated with exposure to X-ray radiation of
0.069-0.135mSv. No adverse effects are expected at this exposure. This
investigation will take 40 minutes adjacent to the outpatient clinic visit.
Also their medical records will be reviewed for collecting data to assess the
state of the acromegaly nowadays and in the past. This study gives a valuable
inside in the persistent craniofacial changes after achieving remission in
patients with acromegaly. Also as a pilotstudy, this study can serve for design
further prospective research in a logitudinal setting. This will lead to
information of the effects of different treatment strategies on the
craniofacial characteristics of patients with acromegaly.
Geert Grooteplein 8
6525 GA Nijmegen
NL
Geert Grooteplein 8
6525 GA Nijmegen
NL
Listed location countries
Age
Inclusion criteria
The subjects are adult patients with acromegaly, who are in remission with only transsphenoidale pituitary surgery treatment, and still visit the outpatient clinic of the department of Endocrinology. Remission is defined as disappearance of clinical symptoms of active GH hypersecretion with in addition normal IGF-1 levels (<=mean +2 standard deviations for age) and suppression of serum GH levels to <2mU/l during oral glucose tolerance test within the first 4 months after surgery.
Exclusion criteria
Patients may not participate in the study if they are pregnant or received oral/maxillofacial surgical treatment in the past.
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 | NL37550.091.11 |