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Upper eyelid sensibility.


- candidate number14234
- NTR NumberNTR3798
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR21-jan-2013
- Secondary IDsNL39947.042.12 MEC UMC Groningen
- Public TitleUpper eyelid sensibility.
- Scientific TitleSensibility of the upper eyelid skin after upper eyelid blepharoplasty.
- ACRONYMBLE-SENS
- hypothesisIt is assumed that the sensibility of the upper eyelid skin will be more or less disturbed after upper eyelid blepharoplasty, and will improve completely or partly in a period of some weeks to months.
- Healt Condition(s) or Problem(s) studiedBlepharochalasis, Upper eyelid blepharoplasty, Sensibility, Sensory disturbance
- Inclusion criteriaPatients with blepharochalasis who will have upper eyelid blepharoplasty for that purpose in June, July or August 2012 in the Bergman Clinic in Heerenveen.
- Exclusion criteriaPatients who had previous operations on their upper eyelids.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 5-jun-2012
- planned closingdate27-sep-2013
- Target number of participants40
- InterventionsAll blepharoplasties are performed by using the same standard surgical techniques by one of the four plastic surgeons who work in the Bergman Clinics Heerenveen. Examination of sensibility is divided into the perception of touch, temperature, pressure and pain. These modalities of sensibility are tested by the tip of a cotton ball, a Tip-Therm, a Cochet-Bonnet aesthesiometer and a neurological pin. The tests are performed at three (perceptions of touch and temperature) or six (perceptions of pressure and pain) different places of the upper eyelid skin.
- Primary outcomePerception of touch, temperature, pressure and pain.
- Secondary outcomeAge, sex, time between operation and testing and development of an wound infection or wound healing disorder.
- TimepointsThe study design is a prospective cohort study during six months. The sensibility of the upper eyelids will be tested four times, namely one hour before the operation, one week afterwards (after removal of the stitches), 6-8 weeks afterwards (when they came for a check up at the OPD) and six months after the upper eyelid blepharoplasty.
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESMD. Shariselle M.W. Pool
- CONTACT for SCIENTIFIC QUERIESMD. Shariselle M.W. Pool
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG)
- PublicationsN/A
- Brief summaryFor providing good pre and post surgical information to patients concerning upper eyelid blepharoplasty it is important to get a better insight in the occurrence of a disturbed sensibility after upper eyelid blepharoplasty, the kind and seriousness, and the duration and degree of recovery.
Therefore the objective of this study is to get insight of the prevalence, nature and severity of the sensory disturbances that may occur in the skin of the upper eyelid after upper eyelid blepharoplasty, as well as the duration and degree of recovery of them.
Country of recruitment: The Netherlands.
- Main changes (audit trail)
- RECORD21-jan-2013 - 30-jan-2013


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