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The return of eyelid function and facial expression in Patients with facial nerve affection is very important for quality of life. Eyelid dysfunction leads to drying and ulceration of cornea which may lead to permanent vision loss.
Facial paralysis is distinguished into two main groups according to the presence or absence of facial fibrillations at needle Electromyography. Recent paralysis, mainly lasting less than two years generally show these signs and are eligible for reactivation of facial nerve by anastomosing it to a donor one (early facial reanimation).
The masseteric nerve (motor branch of trigeminal nerve ) is a reliable donor nerve on early facial reanimation So on this study we examine the advantages and disadvantages of using masseteric nerve to develop a protocol for use of facial reanimation and restoration of function on facial paresis.
Type of the study: observtional Study (clinical trial)
Intervention Model Description:
Patients will be two groups according to the surgical procedure performed as follows:
Allocation and Randomization:
Twenty-four patients will be assigned to Group A early or Group B late (2 groups). group A will be for early and be will be for late cases
Study Setting: Plastic and Reconstructive Surgery Department, Assuit University Hospital and San Paolo university hospital of Milano university.
Study subjects:
Inclusion criteria:
1.Facial nerve affection 2.Patients are generally fit with no other disease interfere with microsurgery. 3.Electromyography showing fibrillations for group A and no fibrillation for group B.
b. Exclusion criteria:
1.Patient with other medical or mental disease-causing generalized paralysis. 2.Syndromic cases. 3.Patients are generally unfit or with any disease interfere with microsurgery.
c. Sample Size Calculation: 24 Sample size was calculated using G power program version 3.1.9.4 (6) in order to detect a significant difference in mean of EFACE score (one of main assessed outcomes in the study ) between two groups under the study , assumed effect size 0.6 based on clinical assumption ( novel study ), α error 0.3 , power 0.80, and allocation ratio 1: 1.
Twenty-two patient plus 10% for dropouts to make total twenty-four (12 patient for every group).
Study tools
All patients in this study are subjected to:
Pre-operative Assessment:
Surgical procedure:
Group A the investigators will avoid the use of muscle relaxants to induce anaesthesia and employ an electro-stimulator to identify the masseteric nerve and the facial nerve branches supplying the affected side.
Exploration on the affected side a facelift-type incision will be performed, and an anterior subcutaneous flap is then will be lifted for several centimetres. In the inferior zygomatic region, the plane of elevation is deepened into the sub-SMAS plane and a composite flap elevated for several centimetres. Following elevation in this plane, the distal facial nerve branches will be identified. The distal portion of the zygomatic nerve is usually located midway between the oral commissure and the helical root. and was confirmed by nerve stimulator.
Then masseteric nerve identified in masseteric muscle and then end to end anastomosis with the central branch of facial nerve Then suction drain will be put and will be removed after 24 hours. Group B The same technique of face lift and harvest the free functioning muscle flap and micro anastomosis of the flap for the superficial temporal system or the facial artery system and the same technique for masseteric nerve identification and end to end anastomosis and to side for prepare cross nerve form the stage one Post-operative All patient will receive physiotherapy and post-operative follow up to detect any wound complication.
Evaluation (After 6 months from the operation)
Complications:
General surgical complication.
General complication due to general anaesthesia.
Specific complication:
Research outcome measures:
a. Primary (main): Comparing the outcomes on EFACE score
Secondary (subsidiary):
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nerve transfer | masseteric nerve to central branch facial nerve. (Early fibrillation on EMG) |
| |
| nerve and free functioning muscle transfer | Masseteric nerve to free functioning muscle transfer. (Late no fibrillation on EMG) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| masseteric nerve to central branch facial nerve | Procedure | masseteric nerve to central branch facial nerve. (Early fibrillation on EMG) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparing the outcomes on EFACE score | difference on the score | up to one year |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of addition of contracted growth factor around the anastomosis | time for nerve activation | up to one year |
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Inclusion Criteria:
Exclusion Criteria:
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Facial nerve affection patients
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ahmed M refaat, MCCh | Contact | 00201008022747 | ahmed.abdelkarim@med.aun.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Ahmed M refaat, mcch | faculty of medcine assiut University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Plastic Surgery Department Assiut University | Recruiting | Asyut | 71511 | Egypt |
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| Masseteric nerve to free functioning muscle transfer | Procedure | Masseteric nerve to free functioning muscle transfer. (Late no fibrillation on EMG) |
|