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Using the Deep Temporal Nerves Versus the Masseteric Nerve for Correction of Eyelid Paresis.

Primary Purpose

Facial Paresis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Deep temporal nerves
massteric nerve
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Facial Paresis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Facial nerve paresis with upper eyelid affection.
  2. Patients are generally fit with no other disease interfere with microsurgery. 3.Electromyography of eyelid showing fibrillations.

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.
  4. Electromyography of eyelid showing no fibrillations.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Deep temporal nerves group

    Masseteric nerve group

    Arm Description

    this group will use deep temporal nerves for reactivation of affected upper facial nerve branch

    this group will use masseteric nerve for reactivation of affected upper facial nerve branch (gold standard)

    Outcomes

    Primary Outcome Measures

    Palpebral fissure size
    Comparing the outcomes on palpebral fissure size between the deep temporal group and the masseteric group after 6 months from the surgery.

    Secondary Outcome Measures

    Full Information

    First Posted
    September 3, 2020
    Last Updated
    September 8, 2020
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04543318
    Brief Title
    Using the Deep Temporal Nerves Versus the Masseteric Nerve for Correction of Eyelid Paresis.
    Official Title
    Using the Deep Temporal Nerves Versus the Masseteric Nerve for Correction of Eyelid Paresis Caused by Facial Nerve Affection. A Comparative Clinical Study.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 1, 2020 (Anticipated)
    Primary Completion Date
    December 1, 2022 (Anticipated)
    Study Completion Date
    April 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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. The deep temporal nerves are motor branches of trigeminal nerve which have some advantage over masseteric nerve as they are longer and reach the zygomatic and frontal branch of facial nerve and it can reach the eyelid and eyebrow to be used for direct neurotization and it supplies temporalis muscle which is an expandable muscle with little effect on mastication and it was reported that they can restore blinking. So on this study we examine the advantages and disadvantages of both nerves to develop a protocol for use of both especially on eyelid reanimation and restoration of blinking on upper facial segment paresis
    Detailed Description
    Type of the study: Prospective Interventional Study (clinical trial) Intervention Model Description: Patients will be randomized into two groups according to the surgical procedure performed as follows: Group A: Deep temporal nerves. Group B: Masseteric nerve. Allocation and Randomization: Twenty-four patients will be randomly assigned to Group A or Group B (2 equal groups). Simple randomization will be performed before surgery by a research nurse using the closed-envelope technique. Twenty-four closed envelopes will be used, each 12 of them carries one of the 2 groups. Closed envelope will be randomly withdrawn the night before surgery to assign the patient to his specific group. Study Setting: Plastic and Reconstructive Surgery Department, Assuit University Hospital Study subjects: Inclusion criteria: Facial nerve paresis with upper eyelid affection. Patients are generally fit with no other disease interfere with microsurgery. Electromyography of eyelid showing fibrillations. 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. 4. Electromyography of eyelid showing no fibrillations. 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 palpebral fissure height (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: Patient history. All patients will do preoperative clinical and neurophysiological assessments of mimetic muscle function and donor nerve status (the ipsilateral deep temporal nerve. The neurophysiological tests will include needle Electromyography (EMG) for recruitment of residual motor unit action potential. If there are no fibrillations patients will have another surgical procedure. The trigeminal motor component will be tested by palpating the temporalis muscle during chewing and via needle EMG of the temporalis muscle to verify availability as a donor motor nerve. Photographic documentation preoperative using standardized frontal face view and adding a scale to photo to measure the palpebral fissure size during three states normal eye opening, resting eye closure and forced eye closure using ImageJ (image processing and analysis in java) computer software (7). Ophthalmological assessment of the affected eye for detection of redness, ulcer, etc. Surgical procedure: Group A We will avoid the use of muscle relaxants to induce anaesthesia and employ an electro-stimulator to identify the deep temporal nerves and the facial nerve branches supplying the eyelid on 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. The deep temporal fascia and temporalis muscle will be incised along the temporal fusion line and will be reflected from the skull to expose the divisions of the deep temporal nerves and the longest branch was traced and prepared for anastomosis end to end with the zygomatic branch after confirming the eyelid supply(8). Then suction drain will be put and will be removed after 24 hours. Group B The same procedure except tracing the masseteric nerve related to masseter muscle and anastomosis will be the same (9). Post-operative All patient will receive physiotherapy and post-operative follow up to detect any wound complication. Evaluation (After 6 months from the operation) Photo documentation: measurement of the palpebral fissure size during three states normal eye opening, resting eye closure , forced eye closure will be done adding eye closure during mastication to compare with preoperative resting eye closure measure using ImageJ (image processing and analysis in java) computer software(7). Donor site morbidity. Follow up Ophthalmological assessment. Complications: General surgical complication. General complication due to general anaesthesia. Specific complication: Delayed healing of nerve anastomosis. Affection of mastication. No postoperative improvement. Research outcome measures: a. Primary (main): Comparing the outcomes on palpebral fissure size between the deep temporal group and the masseteric group after 6 months from the surgery. a. Secondary (subsidiary): Procedure-related morbidity and mortality. Operative time and hospital stay.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Facial Paresis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    24 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Deep temporal nerves group
    Arm Type
    Experimental
    Arm Description
    this group will use deep temporal nerves for reactivation of affected upper facial nerve branch
    Arm Title
    Masseteric nerve group
    Arm Type
    Active Comparator
    Arm Description
    this group will use masseteric nerve for reactivation of affected upper facial nerve branch (gold standard)
    Intervention Type
    Procedure
    Intervention Name(s)
    Deep temporal nerves
    Intervention Description
    Surgical procedure: Group A 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. The deep temporal fascia and temporalis muscle will be incised along the temporal fusion line and will be reflected from the skull to expose the divisions of the deep temporal nerves and the longest branch was traced and prepared for anastomosis end to end with the zygomatic branch after confirming the eyelid supply.
    Intervention Type
    Procedure
    Intervention Name(s)
    massteric nerve
    Intervention Description
    group B The same procedure as group A except tracing the masseteric nerve related to masseter muscle and anastomosis will be the same
    Primary Outcome Measure Information:
    Title
    Palpebral fissure size
    Description
    Comparing the outcomes on palpebral fissure size between the deep temporal group and the masseteric group after 6 months from the surgery.
    Time Frame
    6 months after surgery

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Facial nerve paresis with upper eyelid affection. Patients are generally fit with no other disease interfere with microsurgery. 3.Electromyography of eyelid showing fibrillations. Exclusion Criteria: Patient with other medical or mental disease causing generalized paralysis. Syndromic cases. Patients are generally unfit or with any disease interfere with microsurgery. Electromyography of eyelid showing no fibrillations.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ahmed Abdelkarim, MD
    Phone
    00201008022747
    Email
    ahmed.abdelkarim@med.aun.edu.eg
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ahmed Abdelkarim, MD
    Organizational Affiliation
    Faculty of Medicine,Assiut university,Egypt
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    26316293
    Citation
    Okochi M, Ueda K, Okochi H, Asai E, Sakaba T, Kajikawa A. Facial reanimation using hypoglossal-facial neurorrhaphy with end-to-side coaptation between the jump interpositional nerve graft and hypoglossal nerve: Outcome and duration of preoperative paralysis. Microsurgery. 2016 Sep;36(6):460-6. doi: 10.1002/micr.22393. Epub 2015 Aug 28.
    Results Reference
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    PubMed Identifier
    29125661
    Citation
    Okochi M, Okochi H, Asai E, Sakaba T, Ueda K. Eyelid reanimation using crossface nerve graft: Relationship between surgical outcome and preoperative paralysis duration. Microsurgery. 2018 May;38(4):375-380. doi: 10.1002/micr.30264. Epub 2017 Nov 10.
    Results Reference
    background
    PubMed Identifier
    19319050
    Citation
    Terzis JK, Tzafetta K. The "babysitter" procedure: minihypoglossal to facial nerve transfer and cross-facial nerve grafting. Plast Reconstr Surg. 2009 Mar;123(3):865-876. doi: 10.1097/PRS.0b013e31819ba4bb.
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    PubMed Identifier
    21463951
    Citation
    Biglioli F, Frigerio A, Colombo V, Colletti G, Rabbiosi D, Mortini P, Dalla Toffola E, Lozza A, Brusati R. Masseteric-facial nerve anastomosis for early facial reanimation. J Craniomaxillofac Surg. 2012 Feb;40(2):149-55. doi: 10.1016/j.jcms.2011.03.005. Epub 2011 Apr 3.
    Results Reference
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    PubMed Identifier
    26101977
    Citation
    Karagoz H, Ozturk S, Malkoc I, Diyarbakir S, Demirkan F. Anatomy of the Anterior Deep Temporal Nerve: Implications for Neurotization in Blinking Restoration in Facial Paralysis. Ann Plast Surg. 2015 Sep;75(3):316-8. doi: 10.1097/SAP.0000000000000552.
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    Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
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    Citation
    Schneider CA, Rasband WS, Eliceiri KW. NIH Image to ImageJ: 25 years of image analysis. Nat Methods. 2012 Jul;9(7):671-5. doi: 10.1038/nmeth.2089.
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    PubMed Identifier
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    Citation
    Dauwe PB, Hembd A, De La Concha-Blankenagel E, Saba S, White C, Cardenas-Mejia A, Rozen SM. The Deep Temporal Nerve Transfer: An Anatomical Feasibility Study and Implications for Upper Facial Reanimation. Plast Reconstr Surg. 2016 Sep;138(3):498e-505e. doi: 10.1097/PRS.0000000000002482.
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    Citation
    Gray ML, Hu S, Gorbea E, Mashkevich G. Masseteric-zygomatic nerve transfer for the management of eye closure-smile excursion synkinesis. Am J Otolaryngol. 2020 Jul-Aug;41(4):102479. doi: 10.1016/j.amjoto.2020.102479. Epub 2020 Apr 4.
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    Using the Deep Temporal Nerves Versus the Masseteric Nerve for Correction of Eyelid Paresis.

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