Ignite Creation Date:
2025-12-24 @ 10:02 PM
Ignite Modification Date:
2025-12-25 @ 7:39 PM
Study NCT ID:
NCT05567432
Status:
UNKNOWN
Last Update Posted:
2022-10-05
First Post:
2022-09-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hemostasis in Thyroidectomy, Comparison Between Diathermy and Ligasure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013959', 'term': 'Thyroid Diseases'}], 'ancestors': [{'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013965', 'term': 'Thyroidectomy'}], 'ancestors': [{'id': 'D013507', 'term': 'Endocrine Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'In about 20 participants , the investigators will control bleeding and cut tissues and blood vessels using the diathermy and in the other 20 , investigators will do homeostasis with ligasure.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-01', 'studyFirstSubmitDate': '2022-09-17', 'studyFirstSubmitQcDate': '2022-10-01', 'lastUpdatePostDateStruct': {'date': '2022-10-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Finding the best methode to decrease intraoperative and postoperative bleeding during thyroidectomy', 'timeFrame': '6 months', 'description': 'This study is aiming to make a comparison between the incidence of intraoperative and postoperative bleeding while using diathermy versus using ligasure in homeostasis during thyroidectomy.\n\n* The investigators will do their best to answer this question... 1. ls rate of postoperative complications decrease while using the ligasure than using traditional diathermy ?'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Thyroid']}, 'referencesModule': {'references': [{'pmid': '18082542', 'type': 'BACKGROUND', 'citation': 'Manouras A, Markogiannakis H, Koutras AS, Antonakis PT, Drimousis P, Lagoudianakis EE, Kekis P, Genetzakis M, Koutsoumanis K, Bramis I. Thyroid surgery: comparison between the electrothermal bipolar vessel sealing system, harmonic scalpel, and classic suture ligation. Am J Surg. 2008 Jan;195(1):48-52. doi: 10.1016/j.amjsurg.2007.01.037.'}]}, 'descriptionModule': {'briefSummary': 'Thyroidectomy is one of the most surgeries done by surgeons. Postoperative bleeding is a main complication for this surgery.surgeons usually do homeostasis by traditional diathermy as it is cheep and available in all hospitals and centres.\n\nAtlternatinve surgery devices have become popular to conventional hemostasis in thyroid surgery. These devices reduce operative time and post-operative complication .Investigators thought to examine relative efficiency of two alternative energy devices compared to each other in preventing post-operative complication between diathermy and ligasure.', 'detailedDescription': "Thyroid surgery is one of the most frequently performed surgical procedures worldwide . Nowadays, total thyroidectomy is the recommended procedure for thyroid disease . As total thyroidectomy is the procedure of choice, the most common complication resulting after this surgery is transient hypocalcemia - the incidence being 24% - which increases the morbidity rate and increases the length of hospitalization. Other complications of thyroidectomy include recurrent laryngeal nerve injury which leads to hoarseness of voice, postoperative hemorrhage, dysphagia due to inflammation of the tissues surrounding the esophagus, seroma formation, Horner's syndrome due to injury to the cervical sympathetic chain, and poor healing of the wound with hypertrophy of the scar or wound infection .\n\nAtlternatinve surgery devices have become popular to conventional hemostasis in thyroid surgery. These devices reduce operative time and post-operative complication .Investigators thought to examine relative efficiency of two alternative energy devices compared to each other in preventing post-operative complication between diathermy and ligasure."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Patient with disburbed thyroid function and candidate for for thyroidectomy\n\nExclusion Criteria:\n\n* Low preoperative calcium level and Patient with contraindication of uses of ligasure or diathermy.'}, 'identificationModule': {'nctId': 'NCT05567432', 'briefTitle': 'Hemostasis in Thyroidectomy, Comparison Between Diathermy and Ligasure', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Hemostasis in Thyroidectomy, Comparison Between Diathermy and Ligasure', 'orgStudyIdInfo': {'id': 'htdl'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Patients will do throidectomy using diathermy', 'description': 'In these patients the investigators will control bleeding and cut tissues and blood vessels using the diathermy .', 'interventionNames': ['Procedure: thyroidectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Patients will do thyroidectomy using ligasure .', 'description': 'In these patients the investigators will control bleeding and cut tissues and blood vessels using the liagasure.', 'interventionNames': ['Procedure: thyroidectomy']}], 'interventions': [{'name': 'thyroidectomy', 'type': 'PROCEDURE', 'description': 'use diathermy or ligasure for homeostatic during thyroidectomy', 'armGroupLabels': ['Patients will do throidectomy using diathermy', 'Patients will do thyroidectomy using ligasure .']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mahmoud Aboelhassan, Master', 'role': 'CONTACT', 'email': 'mahmoudaboelhassen37@gmail.com', 'phone': '00201024529525'}, {'name': 'Mostafa Ibrahem, PHD', 'role': 'CONTACT', 'email': 'Mostafamahmoud5622@gmail.com', 'phone': '00201095295794'}], 'overallOfficials': [{'name': 'Mohamed Korany, PHD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assut University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Mahmoud Mohamed Aboelhassan Guishy', 'investigatorAffiliation': 'Assiut University'}}}}