Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2025-12-30 @ 5:43 AM
Study NCT ID:
NCT00506103
Status:
COMPLETED
Last Update Posted:
2007-07-26
First Post:
2007-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The No-Tie Technique Using the Harmonic Scalpel in Total Thyroidectomy With Central Neck Dissection: A Prospective Randomized Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D006996', 'term': 'Hypocalcemia'}, {'id': 'D014826', 'term': 'Vocal Cord Paralysis'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D002128', 'term': 'Calcium Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D014883', 'term': 'Water-Electrolyte Imbalance'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'DEFINED_POPULATION'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-07', 'completionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-07-25', 'studyFirstSubmitDate': '2007-07-21', 'studyFirstSubmitQcDate': '2007-07-24', 'lastUpdatePostDateStruct': {'date': '2007-07-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-07-25', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Thyroidectomy', 'Central neck dissection', 'Harmonic scalpel', 'Perioperative complications'], 'conditions': ['Hemorrhage', 'Hypocalcemia', 'Vocal Cord Palsy']}, 'referencesModule': {'references': [{'pmid': '15746789', 'type': 'BACKGROUND', 'citation': 'Cordon C, Fajardo R, Ramirez J, Herrera MF. A randomized, prospective, parallel group study comparing the Harmonic Scalpel to electrocautery in thyroidectomy. Surgery. 2005 Mar;137(3):337-41. doi: 10.1016/j.surg.2004.09.011.'}]}, 'descriptionModule': {'briefSummary': 'To investigate the safety and efficacy of the no-tie technique using the harmonic scalpel (HS) in terms of the operating time and complications in total thyroidectomy with central neck dissection (CND). Recently, the HS has been used as an alternative to conventional hand-tied ligation for hemostasis in thyroid surgery, which is a time-consuming procedure. Very limited data have been published on evidence of its safety in total thyroidectomy accompanied by CND without supplementary hand-tied ligation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with total thyroidectomy plus central neck dissection\n* if primary tumor size was more than 1 cm in papillary thyroid cancer\n* there was any evidence of lymph node enlargement in paratracheal lymph node group preoperatively or intraoperatively\n* patients who underwent minimal resection of the surrounding soft tissues, including the sternothyroid or sternohyoid muscle, for extracapsular extension of thyroid cancer\n\nExclusion Criteria:\n\n* patients who required lateral compartment neck dissection or mediastinal dissection for preexisting lymph node metastasis\n* patients had clinical or laboratory indicators of coagulation disorders\n* patients with preexisiting vocal cord palsy, fixation of the tumor to the recurrent laryngeal nerve requiring trnasection of the nerve\n* patients with massive extracapsular extension to the surrounding soft tissues.'}, 'identificationModule': {'nctId': 'NCT00506103', 'briefTitle': 'The No-Tie Technique Using the Harmonic Scalpel in Total Thyroidectomy With Central Neck Dissection: A Prospective Randomized Study', 'organization': {'class': 'OTHER', 'fullName': 'Soonchunhyang University Hospital'}, 'orgStudyIdInfo': {'id': 'SCHHN'}}, 'contactsLocationsModule': {'locations': [{'city': 'Bucheon-si', 'country': 'South Korea', 'facility': 'Dept. of otolaryngology-Head and Neck Surgery, Soonchunhyang University College of Medicine', 'geoPoint': {'lat': 37.49889, 'lon': 126.78306}}], 'overallOfficials': [{'name': 'Yoon Woo Koh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dept. of Otolaryngology-Head and Neck Surgery, Soonchunhyang University College of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Soonchunhyang University Hospital', 'class': 'OTHER'}}}}