Ignite Creation Date:
2025-12-25 @ 4:46 AM
Ignite Modification Date:
2025-12-26 @ 3:48 AM
Study NCT ID:
NCT04458818
Status:
COMPLETED
Last Update Posted:
2021-04-29
First Post:
2020-06-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Novel Approach for Thyroplasty Type 1, With Prolene Mesh. A Prospective Study.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014826', 'term': 'Vocal Cord Paralysis'}, {'id': 'D007822', 'term': 'Laryngeal Neoplasms'}], 'ancestors': [{'id': 'D007818', 'term': 'Laryngeal Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D020421', 'term': 'Vagus Nerve Diseases'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'f9noman@gmail.com', 'phone': '+923313358884', 'title': 'Dr Muhammad Noman Karim', 'organization': 'Combined Military Hospital Kharian, Punjab Pakistan'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 year follow up was kept for all the patients.', 'eventGroups': [{'id': 'EG000', 'title': 'Prolene Mesh Implant', 'description': 'The Group of Patients who were offered Prolene mesh Laryngeal implants for Vocal Cord Medialization.\n\nProlene Mesh Vocal Cord Medialization Implant: The surgery will be performed under local anesthesia (lignocaine with adrenaline 2%) and procedural sedation with propofol 25-100mcg/kg/min (only sedative dose) will be administered, so that the patient remains vocally responsive during the procedure. Incision will be made at the lower border of thyroid cartilage under aseptic measures. Skin flaps will be raised in sub-platysmal plane, strap muscles will be separated in the midline to expose the laryngeal cartilaginous framework. A simple laryngeal window approach will be used to place the Ethicon prolene mesh 6 x 6cm Swiss roll, secured with prolene 2/0 suture trimmed to the required size. Post op voice analysis will be done on 7th day and 14th post-operative day. Monthly follow up will be advised after that.', 'otherNumAtRisk': 39, 'deathsNumAtRisk': 39, 'otherNumAffected': 5, 'seriousNumAtRisk': 39, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'URTI', 'notes': 'Upper respiratory tract infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 39, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'skin infection', 'notes': 'Wound infection, post operatively', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 39, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Mean Phonation Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Prolene Mesh Implant', 'description': 'The Group of Patients who were offered Prolene mesh Laryngeal implants for Vocal Cord Medialization.\n\nProlene Mesh Vocal Cord Medialization Implant: The surgery will be performed under local anesthesia (lignocaine with adrenaline 2%) and procedural sedation with propofol 25-100mcg/kg/min (only sedative dose) will be administered, so that the patient remains vocally responsive during the procedure. Incision will be made at the lower border of thyroid cartilage under aseptic measures. Skin flaps will be raised in sub-platysmal plane, strap muscles will be separated in the midline to expose the laryngeal cartilaginous framework. A simple laryngeal window approach will be used to place the Ethicon prolene mesh 6 x 6cm Swiss roll, secured with prolene 2/0 suture trimmed to the required size. Post op voice analysis will be done on 7th day and 14th post-operative day. Monthly follow up will be advised after that.'}], 'classes': [{'title': 'pre operative', 'categories': [{'measurements': [{'value': '7.74', 'spread': '1.712', 'groupId': 'OG000'}]}]}, {'title': 'post operative', 'categories': [{'measurements': [{'value': '14.08', 'spread': '3.390', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Preoperative and 14th Postoperative day', 'description': "Pre and postoperative voices will be recorded with a standard microphone at 15cm distance from the mouth in a quiet room. Maximum phonation time (MPT) while vocalizing the vowel sound 'eee' will be measured in seconds. Maximum three attempts will be allowed to each patient and the better score of the three will be recorded in the data.", 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Maximum Words Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Prolene Mesh Implant', 'description': 'The Group of Patients who were offered Prolene mesh Laryngeal implants for Vocal Cord Medialization.\n\nProlene Mesh Vocal Cord Medialization Implant: The surgery will be performed under local anesthesia (lignocaine with adrenaline 2%) and procedural sedation with propofol 25-100mcg/kg/min (only sedative dose) will be administered, so that the patient remains vocally responsive during the procedure. Incision will be made at the lower border of thyroid cartilage under aseptic measures. Skin flaps will be raised in sub-platysmal plane, strap muscles will be separated in the midline to expose the laryngeal cartilaginous framework. A simple laryngeal window approach will be used to place the Ethicon prolene mesh 6 x 6cm Swiss roll, secured with prolene 2/0 suture trimmed to the required size. Post op voice analysis will be done on 7th day and 14th post-operative day. Monthly follow up will be advised after that.'}], 'classes': [{'title': 'pre operative', 'categories': [{'measurements': [{'value': '11.33', 'spread': '3.359', 'groupId': 'OG000'}]}]}, {'title': 'post operative', 'categories': [{'measurements': [{'value': '18.28', 'spread': '5.047', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Preoperative and 14th Postoperative day', 'description': 'Pre and postoperative voices will be recorded with a standard microphone at 15cm distance from the mouth in a quiet room. Maximum words count (MWC) in a single breath (counting numbers) will be recorded pre and post operatively. Maximum three attempts will be allowed to each patient and the better score of the three will be recorded in the data.', 'unitOfMeasure': 'words', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Voice Quality on Visual Analogue Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Prolene Mesh Implant', 'description': 'The Group of Patients who were offered Prolene mesh Laryngeal implants for Vocal Cord Medialization.\n\nProlene Mesh Vocal Cord Medialization Implant: The surgery will be performed under local anesthesia (lignocaine with adrenaline 2%) and procedural sedation with propofol 25-100mcg/kg/min (only sedative dose) will be administered, so that the patient remains vocally responsive during the procedure. Incision will be made at the lower border of thyroid cartilage under aseptic measures. Skin flaps will be raised in sub-platysmal plane, strap muscles will be separated in the midline to expose the laryngeal cartilaginous framework. A simple laryngeal window approach will be used to place the Ethicon prolene mesh 6 x 6cm Swiss roll, secured with prolene 2/0 suture trimmed to the required size. Post op voice analysis will be done on 7th day and 14th post-operative day. Monthly follow up will be advised after that.'}], 'classes': [{'title': 'pre operative', 'categories': [{'measurements': [{'value': '4.77', 'spread': '1.224', 'groupId': 'OG000'}]}]}, {'title': 'post operative', 'categories': [{'measurements': [{'value': '7.64', 'spread': '1.308', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Preoperative and 14th Postoperative day', 'description': 'For subjective assessment of voice quality Visual (1-10) analogue score (VAS) will be used both pre and postoperatively. Score 1 will be the score for lowest and 10 being the best score for voice quality.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Prolene Mesh Implant', 'description': 'The Group of Patients who were offered Prolene mesh Laryngeal implants for Vocal Cord Medialization.\n\nProlene Mesh Vocal Cord Medialization Implant: The surgery will be performed under local anesthesia (lignocaine with adrenaline 2%) and procedural sedation with propofol 25-100mcg/kg/min (only sedative dose) will be administered, so that the patient remains vocally responsive during the procedure. Incision will be made at the lower border of thyroid cartilage under aseptic measures. Skin flaps will be raised in sub-platysmal plane, strap muscles will be separated in the midline to expose the laryngeal cartilaginous framework. A simple laryngeal window approach will be used to place the Ethicon prolene mesh 6 x 6cm Swiss roll, secured with prolene 2/0 suture trimmed to the required size. Post op voice analysis will be done on 7th day and 14th post-operative day. Monthly follow up will be advised after that.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'May 01 2020', 'groupId': 'FG000', 'numSubjects': '39'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Jan 30 2021', 'groupId': 'FG000', 'numSubjects': '39'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '01 May 2020 - 30 Jan 2021', 'preAssignmentDetails': 'Before inducting into the study, patients were tested with exclusion criteria i.e Neoplasia, trauma and muscular dystrophy cases, and inclusion criteria i.e.15 years and younger, vocal cord paralysis and voice disability.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Prolene Mesh Implant', 'description': 'The Group of Patients who were offered Prolene mesh Laryngeal implants for Vocal Cord Medialization.\n\nProlene Mesh Vocal Cord Medialization Implant: The surgery will be performed under local anesthesia (lignocaine with adrenaline 2%) and procedural sedation with propofol 25-100mcg/kg/min (only sedative dose) will be administered, so that the patient remains vocally responsive during the procedure. Incision will be made at the lower border of thyroid cartilage under aseptic measures. Skin flaps will be raised in sub-platysmal plane, strap muscles will be separated in the midline to expose the laryngeal cartilaginous framework. A simple laryngeal window approach will be used to place the Ethicon prolene mesh 6 x 6cm Swiss roll, secured with prolene 2/0 suture trimmed to the required size. Post op voice analysis will be done on 7th day and 14th post-operative day. Monthly follow up will be advised after that.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '32', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Pakistan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-03-03', 'size': 127525, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-03-21T10:49', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'No Masking. Patients in one arm are provided with prolene mesh implant, and is known by the patient, health care provider and the assessor.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'The single group will be implanted with Prolene mesh made into Swiss rolls and placed in Laryngeal Window between the cartilage and inner periosteum,'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-28', 'studyFirstSubmitDate': '2020-06-26', 'resultsFirstSubmitDate': '2021-03-22', 'studyFirstSubmitQcDate': '2020-07-02', 'lastUpdatePostDateStruct': {'date': '2021-04-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-04-28', 'studyFirstPostDateStruct': {'date': '2020-07-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Mean Phonation Time', 'timeFrame': 'Preoperative and 14th Postoperative day', 'description': "Pre and postoperative voices will be recorded with a standard microphone at 15cm distance from the mouth in a quiet room. Maximum phonation time (MPT) while vocalizing the vowel sound 'eee' will be measured in seconds. Maximum three attempts will be allowed to each patient and the better score of the three will be recorded in the data."}, {'measure': 'Change in Maximum Words Count', 'timeFrame': 'Preoperative and 14th Postoperative day', 'description': 'Pre and postoperative voices will be recorded with a standard microphone at 15cm distance from the mouth in a quiet room. Maximum words count (MWC) in a single breath (counting numbers) will be recorded pre and post operatively. Maximum three attempts will be allowed to each patient and the better score of the three will be recorded in the data.'}, {'measure': 'Change in Voice Quality on Visual Analogue Score', 'timeFrame': 'Preoperative and 14th Postoperative day', 'description': 'For subjective assessment of voice quality Visual (1-10) analogue score (VAS) will be used both pre and postoperatively. Score 1 will be the score for lowest and 10 being the best score for voice quality.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Voice Rehabilitation', 'Vocal Medialization', 'Prolene mesh implant'], 'conditions': ['Vocal Cord Paralysis', 'Phonasthenia', 'Presbylarynges', 'Idiopathic Vocal Cord Paralysis', 'Ca Larynx']}, 'descriptionModule': {'briefSummary': 'Larynx performs important functions of the aero-digestive tract, it has vital role in control of breathing, phonation, deglutition and protection of lower respiratory tract from aspiration. Vocal cord paralysis is a common and at times debilitating laryngeal dysfunction that has great social and economic impact on patients life. Medialization thyroplasty (MT), if done accurately and up to the expectations of the patient is very rewarding. However different materials with some modifications in the technique of the classical Isshiki type 1 thyroplasty is in practice, each with its own profile of benefits and disadvantages. Most of them are costly and out of reach of general population. In this regard, we aim to test a prolene mesh implant, which is easily available and can be placed with relative ease.', 'detailedDescription': "Introduction: Larynx performs important functions of the aero-digestive tract, it has vital role in control of breathing, phonation, deglutition and protection of lower respiratory tract from aspiration. The function of Vocal cord is central to all the Laryngeal functions, even unilateral paralysis can have profound effect on overall laryngeal functionality especially in sound production. Around 80% of all the jobs in the world are somehow dependent upon social communication. Vocal cord paralysis is a common and at times debilitating laryngeal dysfunction that has great social and economic impact on patients life. Medialization thyroplasty (MT), if done accurately and up to the expectations of the patient is very rewarding. However different materials with some modifications in the technique of the classical Isshiki type 1 thyroplasty is in vogue, each with its own profile of benefits and disadvantages. In this regard a large variety of complex materials are in use, which are not routinely available in developing countries and some of them have not been cleared by the host countries medical authorities. Most of them are costly and out of reach of general population. In this regard, we aim to test a prolene mesh implant, which is easily available and can be placed with relative ease. We recommend some modifications in the original technique, which would not require the complex measurements and costly equipment. Even it can be performed without fiber-optic laryngoscope guidance. Prolene is already in use in wide range of procedures worldwide, approved by Federal drug administration in 1997 but it has never been used in larynx. We intend to explore the efficacy of prolene mesh as an implant for vocal cord medialization in terms of patient satisfaction and voice outcome.\n\nObjective: To evaluate a new approach of vocal cord medialization using prolene mesh as an implant material.\n\nStudy Design: Interventional, prospective study.. Place and Duration of study: Ent departments of multiple tertiary care hospitals of Pakistan from Jun 2020 and onwards.\n\nMaterials and Methods: Patients of age 15 years onwards and with vocal cord paralysis/ paresis due to multiple causes would included in the study. Patients with neoplasm, trauma and underlying muscular dystrophy are to be excluded. All patients will be counselled properly and given the choice of intervention by prolene mesh implant. Consenting patients will be subjected to routine blood investigations with fiber optic laryngoscopy and imaging with Computerized Tomography scan (where applicable). Procedure will be performed under local anesthesia with mild sedation, so that the patient will remain vocally responsive for the assessment of voice and breathing intraoperatively. Pre and postoperative voices will be recorded with a standard microphone at 15cm distance from the mouth in a quiet room. Maximum phonation time (MPT) while vocalizing the vowel sound 'eee' and Maximum words count (MWC) in a single breath (counting numbers) will be recorded pre and post operatively. Maximum three attempts will be allowed to each patient and the better score of the three will be recorded in the data. For subjective assessment of voice quality Visual (1-10) analogue score (VAS) will be used both pre and postoperatively. For objective assessment of patients a customized Voice Handicap Index (VHI-10) will be used.\n\nModified VHI-10 Questionnaire\n\n1. My voice makes it difficult for people to hear me. 0 1 2 3 4 5\n2. I run out of air when I talk. 0 1 2 3 4 5\n3. People have difficulty understanding me in noisy room. 0 1 2 3 4 5\n4. I use a great deal of effort to speak. 0 1 2 3 4 5\n5. My family has difficulty hearing me when I call them throughout the house. 0 1 2 3 4 5\n6. I use phone less often than I would like to. 0 1 2 3 4 5\n7. I am tense when I am talking to others because of my voice. 0 1 2 3 4 5\n8. I tend to avoid groups of people because of my voice. 0 1 2 3 4 5\n9. People seem irritated with my voice. 0 1 2 3 4 5\n10. People ask what's wrong with my voice. 0 1 2 3 4 5 VHI : Voice Handicap Index 0 = never, 1 = almost never (occasionally), 2 = sometimes, 3 = almost always, 4 = always Fig 1.1 Modified Voice Handicap Index (VHI-10)\n\nHospital ethical committee's approval will be obtained. The surgery will be performed under local anesthesia (lignocaine with adrenaline 2%) and procedural sedation with propofol 25-100mcg/kg/min (only sedative dose) will be administered, so that the patient remains vocally responsive during the procedure. Incision will be made at the lower border of thyroid cartilage under aseptic measures. Skin flaps will be raised in sub-platysmal plane, strap muscles will be separated in the midline to expose the laryngeal cartilaginous framework. A simple laryngeal window approach will be used to place the Ethicon prolene mesh 6 x 6 cm Swiss roll, secured with prolene 2/0 suture trimmed to the required size. Post op voice analysis will be done on 14th post-operative day. Routine monthly follow up for 3 months will be advised after that.\n\nThe results will be analyzed using Internal IBM SPSS Statistics version 20. Variables defined would be compared between the preoperative and postoperative groups. For normal data paired sample t-test would be used and for abnormally distributed data non parametric t-test would be used. P-value of less than 0.05 will be taken as significant."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age more than 15 years\n* Vocal cord paralysis\n\nExclusion Criteria:\n\n* Patients with neoplasms\n* Trauma\n* Muscular dystrophies'}, 'identificationModule': {'nctId': 'NCT04458818', 'briefTitle': 'A Novel Approach for Thyroplasty Type 1, With Prolene Mesh. A Prospective Study.', 'organization': {'class': 'OTHER', 'fullName': 'Pak Emirates Military Hospital'}, 'officialTitle': 'A Novel Approach for Thyroplasty Type 1, With Prolene Mesh. A Prospective Study.', 'orgStudyIdInfo': {'id': 'Prolene mesh VC medialization'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prolene Mesh Implant', 'description': 'The Group of Patients who were offered Prolene mesh Laryngeal implants for Vocal Cord Medialization.', 'interventionNames': ['Procedure: Prolene Mesh Vocal Cord Medialization Implant']}], 'interventions': [{'name': 'Prolene Mesh Vocal Cord Medialization Implant', 'type': 'PROCEDURE', 'description': 'The surgery will be performed under local anesthesia (lignocaine with adrenaline 2%) and procedural sedation with propofol 25-100mcg/kg/min (only sedative dose) will be administered, so that the patient remains vocally responsive during the procedure. Incision will be made at the lower border of thyroid cartilage under aseptic measures. Skin flaps will be raised in sub-platysmal plane, strap muscles will be separated in the midline to expose the laryngeal cartilaginous framework. A simple laryngeal window approach will be used to place the Ethicon prolene mesh 6 x 6cm Swiss roll, secured with prolene 2/0 suture trimmed to the required size. Post op voice analysis will be done on 7th day and 14th post-operative day. Monthly follow up will be advised after that.', 'armGroupLabels': ['Prolene Mesh Implant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '500090', 'city': 'Kharian', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'ENT Departments', 'geoPoint': {'lat': 32.81612, 'lon': 73.88697}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Muhammad Rashid', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor of ENT', 'investigatorFullName': 'Muhammad Rashid', 'investigatorAffiliation': 'Pak Emirates Military Hospital'}}}}