[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100533434":3},{"organization":4,"outcomesModule":7,"designInfo":52,"detailedDescription":59,"studyPopulation":51,"armGroups":60,"interventions":73,"overallOfficials":82,"centralContacts":90,"locations":100,"responsibleParty":120,"collaborators":51,"id":123,"slug":51,"hasResults":124,"nctId":125,"briefTitle":126,"officialTitle":126,"acronym":51,"eligibilityCriteria":127,"healthyVolunteers":124,"sex":128,"minAge":129,"maxAge":51,"enrollmentInfo":130,"targetDuration":51,"studyType":133,"phases":134,"briefSummary":136,"conditions":137,"keywords":140,"overallStatus":103,"whyStopped":51,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":151},{"fullName":5,"class":6},"Tseung Kwan O Hospital, Hong Kong","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":36,"otherOutcomes":51},[9,13,15,17,19,20,21,24,25,26,29,30,31,34],{"measure":10,"description":11,"timeFrame":12},"Patient's satisfactory score","Visual analogue scale 0-10","Post-operative day 1",{"measure":10,"description":11,"timeFrame":14},"Post-operative 2 weeks",{"measure":10,"description":11,"timeFrame":16},"Post-operative 6 months",{"measure":18,"description":11,"timeFrame":12},"Post-operative pain",{"measure":18,"description":11,"timeFrame":14},{"measure":18,"description":11,"timeFrame":16},{"measure":22,"description":23,"timeFrame":12},"Voice quality of life","Voice Handicap Index - 30 assessing functional, physical and emotional scales",{"measure":22,"description":23,"timeFrame":14},{"measure":22,"description":23,"timeFrame":16},{"measure":27,"description":28,"timeFrame":12},"Swallowing quality of life","MD Anderson dysphagia inventory (MDADI)",{"measure":27,"description":28,"timeFrame":14},{"measure":27,"description":28,"timeFrame":16},{"measure":32,"description":33,"timeFrame":14},"Complication rate and types","Lower lip numbness, skin bruising or injury, wound infection, vocal cord paralysis, temporary hypoparathyroidism",{"measure":32,"description":35,"timeFrame":16},"Lower lip numbness, vocal cord paralysis, permanent hypoparathyroidism",[37,41,45,48],{"measure":38,"description":39,"timeFrame":40},"Inpatient stay","Number of days of inpatient stay","An average of 0-2 days after the operation",{"measure":42,"description":43,"timeFrame":44},"Operative time","Minutes","Intra-operatively",{"measure":46,"description":47,"timeFrame":44},"Blood loss","Volume",{"measure":49,"description":50,"timeFrame":44},"Rate of conversion to open surgery","Percentage of conversion",null,{"allocation":53,"interventionModel":54,"interventionModelDescription":55,"primaryPurpose":56,"observationalModel":51,"timePerspective":51,"maskingInfo":57},"NON_RANDOMIZED","PARALLEL","Prospective case control study","TREATMENT",{"masking":58,"maskingDescription":51,"whoMasked":51},"NONE","This is a prospective case control study involving a total 40 patients, with 20 stratified into the test group receiving surgery under transoral endoscopic thyroidectomy vestibular approach (TOETVA) and 20 patients to the control group under traditional open approach. Subjects will be assigned to either group without randomization. Patients satisfactory score, voice and swallowing quality of life outcomes will be assessed using Voice Handicap Index (VHI) and MD Anderson Dysphagia Inventory (MDADI) outcomes. Surgical outcomes, for instance, lower lip numbness, skin injury, operative time, blood loss, vocal cord paralysis, temporary and permanent hypoparathyroidism will be assessed.",[61,67],{"label":62,"type":63,"description":64,"interventionNames":65},"Transoral endoscopic thyroidectomy vestibular approach (TOETVA)","EXPERIMENTAL","Test group receiving surgery under transoral endoscopic thyroidectomy vestibular approach (TOETVA)",[66],"Procedure: Transoral endoscopic thyroidectomy vestibular approach (TOETVA)",{"label":68,"type":69,"description":70,"interventionNames":71},"Traditional open surgery","ACTIVE_COMPARATOR","Control group receiving traditional open thyroidectomy",[72],"Procedure: Traditional Open Thyroidectomy",[74,78],{"type":75,"name":62,"description":76,"armGroupLabels":77,"otherNames":51},"PROCEDURE","Remote access thyroid surgery",[62],{"type":75,"name":79,"description":80,"armGroupLabels":81,"otherNames":51},"Traditional Open Thyroidectomy","Open thyroidectomy via trans-cervical approach",[68],[83,87],{"name":84,"affiliation":85,"role":86},"Jason YK Chan","Department of Otorhinolaryngology, Head and Neck Surgery, The Chinese University of Hong Kong","STUDY_DIRECTOR",{"name":88,"affiliation":85,"role":89},"Zenon Yeung","PRINCIPAL_INVESTIGATOR",[91,96],{"name":92,"role":93,"phone":94,"phoneExt":51,"email":95},"Cherrie Ng","CONTACT","+85235051409","cherrieng@ent.cuhk.edu.hk",{"name":97,"role":93,"phone":98,"phoneExt":51,"email":99},"Thomas Hui","+85239493549","hsc526@ha.org.hk",[101],{"facility":102,"status":103,"city":104,"state":51,"zip":51,"country":104,"countryCode":105,"cosmosGeoPoint":106,"geoPoint":111,"contacts":112},"Department of Otorhinolaryngology, Head and Neck Surgery, United Christian Hospital and Tseung Kwan O Hospital","RECRUITING","Hong Kong","HK",{"type":107,"coordinates":108},"Point",[109,110],114.17469,22.27832,{"lat":110,"lon":109},[113,117],{"name":114,"role":93,"phone":115,"phoneExt":51,"email":116},"Zenon Yeung, MbChB","+852-39495442","dr.zenon.yeung@gmail.com",{"name":118,"role":93,"phone":119,"phoneExt":51,"email":99},"Thomas Hui, BSc","+852-39493549",{"type":89,"investigatorFullName":121,"investigatorTitle":122,"investigatorAffiliation":5,"oldNameTitle":51,"oldOrganization":51},"YEUNG WING CHI ZENON","Consultant, Department of Otorhinolaryngology, Head and Neck Surgery","100533434",false,"NCT06225765","A Prospective Trial Comparing Transoral Endoscopic Thyroidectomy Vestibular Approach (TOETVA) and Conventional Open Thyroidectomy","Inclusion Criteria:\n\n* Benign thyroid nodule less than 4cm\n* Suspicious malignant thyroid nodule less than 2cm, suitable for transoral endoscopic surgery\n\nExclusion Criteria:\n\n* Patients under 18 years old\n* Contraindication to general anaesthesia\n* Vulnerable population (e.g. Cognitive impairment, pregnant)\n* Previous anterior neck surgery\n* Previous radiotherapy at the head and neck region\n* Malignant thyroid nodule \\> 2cm\n* Presence of another malignancy, lateral neck, or distant metastasis\n* Retrosternal goitre\n* Cervical spine disease precluding extension of the neck\n* Obesity with BMI \\> 35kg\u002Fm2\n* Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic intervention\n* Untreated active infection\n* Non-correctable coagulopathy\n* Emergency surgery","ALL","18 Years",{"count":131,"type":132},40,"ESTIMATED","INTERVENTIONAL",[135],"NA","To determine if transoral endoscopic thyroidectomy vestibular approach (TOETVA) is a safe and effective procedure compared to traditional open thyroidectomy. Surgical outcomes, patients' satisfaction, voice and swallowing outcomes will be assessed.",[138,139],"Benign Thyroid Nodule","Suspicious Malignant Thyroid Nodule",[141],"Thyroid nodule","2024-07-06",{"date":144,"type":145},"2024-07-09","ACTUAL",{"date":147,"type":145},"2024-07-01",{"date":149,"type":132},"2026-09-30",{"name":5,"class":6},1]