The objective of this study is to find the prevalence and type of sensibility problems after upper blepharoplasty. Also we will study the postoperative course of possible problems in sensibility.
ID
Source
Brief title
Condition
- Skin and subcutaneous tissue therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameters are sense of pressure, tactile sensation,
temperature and pain.
Also we will look at the time (number of weeks) that has passed between
blepharoplasty and the time of testing.
The sense of pressure will be registered as level of pressure (value between
0,5 and 6,0 cm). The sense of tactile sensation, temperature and pain will be
registered as intact or disturbed. The results for the sense of pressure will
be presented as the average level of pressure. For the sense of tactile
sensation, temperature and pain, the percentage of patients whereby the
modality is intact will be the primary outcome measure.
Secondary outcome
The age (in years) and sex will be registered for all patients as these
variables could possibly influence the recovery of sensibility of the upper
eyelid after blepharoplasty. In addition, it will be listed as a patient
develops a wound infection or wound healing disorder during the follow-up
appointments, because this could affect (the recovery of) the sensiility of the
upper eyelid too.
Background summary
The blepharoplasty is one of the most performed plastic surgery operations.
Regularly patients notice a diminishing sensibility of the upper eyelid. The
plastic surgeon can often not answer the question how long this loss of
sensibility will last and whether it will come back, as little research has
taken place in this area. It is assumed that the sensibility of the upper
eyelid will be more or less disturbed, and will improve in a period of some
weeks to months completely of partly. For providing good pre and post surgical
information to the patient concerning the upper eyelid correction it is
important to get a better insight in the occurrance of a disturbed sensibility
after blepharoplasty, the kind and seriousness, and the duration and degree of
recovery.
Study objective
The objective of this study is to find the prevalence and type of sensibility
problems after upper blepharoplasty.
Also we will study the postoperative course of possible problems in
sensibility.
Study design
The study design is a prospective cohort study during six months.
Patients with blepharochalasis who will have an upper eyelid correction in the
Bergman Clinic in Heerenveen, will be approached for participation in the
study. The sensibility of their upper eyelid will be tested 4 times, namely one
hour before, 1 week after (after removal of the stitches), 6-8 weeks after
(when they come for a check up at the OPD) and 6 months after surgery.
The tests will take place in the Bergman Clinic and will last 15-20 minutes
each test.
Study burden and risks
The preoperative tests are done one hour before the operation is performed. The
tests after one week will take place after the removal of the stitches. The
third set of tests will be done when the patient comes for the check up at the
OPD after 6-8 weeks. Six months after the upper blepharoplasty, the patient has
to come to the Bergman Clinic in Heerenveen solely for the investigation. The
tests take place in a room where privacy is guaranteed. Before every test the
sensations of the instruments used for the tests will be demonstrated to the
patients. The test are not invasive or painful and do not interfere with the
treatment that the patient had or will have (blepharoplasty).
The minimal stress caused by the tests is therefore very reasonable in
comparison to the benefits the study will have.
Hanzeplein 1
Groningen 9700 RB
NL
Hanzeplein 1
Groningen 9700 RB
NL
Listed location countries
Age
Inclusion criteria
Patients with blepharochalasis who will undergo upper eyelid blepharoplasty in the Bergman Clinics Heerenveen between June and September 2012.
Exclusion criteria
Previous surgery on the eyelids.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL39947.042.12 |
| OMON | NL-OMON22007 |