Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2025-12-30 @ 12:34 AM
Study NCT ID:
NCT05367869
Status:
UNKNOWN
Last Update Posted:
2022-05-24
First Post:
2022-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Intraoperative Spraying Methylene Blue In Thyroidectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Impact of Intraoperative Spraying Methylene Blue In Thyroidectomy'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2023-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-22', 'studyFirstSubmitDate': '2022-04-28', 'studyFirstSubmitQcDate': '2022-05-04', 'lastUpdatePostDateStruct': {'date': '2022-05-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrent laryngeal nerve injury', 'timeFrame': '2 weeks'}, {'measure': 'Parathyroid gland Injuries', 'timeFrame': '3 months'}, {'measure': 'Intraoperative injury to trachea', 'timeFrame': '2 weeks'}, {'measure': 'Operative time', 'timeFrame': '1 day'}, {'measure': 'Presence of residual or recurrence', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'Hoarseness of voice', 'timeFrame': '3 months', 'description': 'temporary or permanent (by clinical evaluation and vocal cord examination)'}, {'measure': 'Stridor', 'timeFrame': '3 months', 'description': 'temporary or permanent (by clinical evaluation and vocal cord examination)'}, {'measure': 'Hypoparathyroidism', 'timeFrame': '3 months', 'description': 'temporary or permanent (level of para thormone hormone )'}, {'measure': 'Hypocalcaemia', 'timeFrame': '3 months', 'description': 'temporary or permanent ( level of total and free serum calcium )'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['methylene blue', 'spraying', 'intraoperative', 'thyroidectomy'], 'conditions': ['Impact of Intraoperative Spraying Methylene Blue In Thyroidectomy']}, 'descriptionModule': {'briefSummary': 'Impact of Intraoperative Spraying methylene blue In thyroidectomy', 'detailedDescription': 'General anaesthesia ,supine position with hyperextension to the neck Low collar incision to the neck , incision to the skin and platysma muscle and fascia ,upper and lower flaps are developed ,separation of strap muscles and identification of the thyroid gland after freeing of investing fascia Ligation of the middle thyroid vein and ligation and separation of the superior pedicle away from the external laryngeal nerve At this point of operation and before ligation of inferior pedicle, methylene blue 0.05% spraying is applied to the field the amount varies according to size of the thyroid lobe and variation in population and neck size Thyroid gland stained by bluish color , recurrent laryngeal nerve not stained or minimally stained so we can avoid injury to it parathyroid glands get red of the stain after about 3 minutes so we can avoid injury to it thyroid gland lose its stain in about 15 minutes so we can remove any residual and decrease residual tissue or recurrence'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Both sexes\n* Age more than 15 years\n* All pathologies need surgery eg. (mutinodular goiter, malignancy , thyroid nodule,…..etc\n* Total thyroidectomy\n\nExclusion Criteria:\n\n* Pregnant females\n* Previous neck surgery or recurrent thyroid surgery\n* Subtotal or partial thyroidectomy\n* Age less than 15 years\n* Preoperative affection to vocal cord\n* Preoperative hypocalcaemia'}, 'identificationModule': {'nctId': 'NCT05367869', 'acronym': 'methylene', 'briefTitle': 'Impact of Intraoperative Spraying Methylene Blue In Thyroidectomy', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Qena Oncology Center'}, 'officialTitle': 'Impact of Intraoperative Spraying Methylene Blue In Thyroidectomy', 'orgStudyIdInfo': {'id': 'Qena Oncology Center'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intraoperative Spraying Methylene Blue In Thyroidectomy', 'interventionNames': ['Procedure: Impact of Intraoperative Spraying Methylene Blue In Thyroidectomy']}], 'interventions': [{'name': 'Impact of Intraoperative Spraying Methylene Blue In Thyroidectomy', 'type': 'PROCEDURE', 'description': 'General anaesthesia ,supine position with hyperextension to the neck Low collar incision to the neck , incision to the skin and platysma muscle and fascia ,upper and lower flaps are developed ,separation of strap muscles and identification of the thyroid gland after freeing of investing fascia Ligation of the middle thyroid vein and ligation and separation of the superior pedicle away from the external laryngeal nerve At this point of operation and before ligation of inferior pedicle methylene blue 0.05% spraying is applied to the field the amount varies according to size of the thyroid lobe and variation in population and neck size Thyroid gland stained by bluish color , recurrent laryngeal nerve not stained or minimally stained so we can avoid injury to it parathyroid glands get red of the stain after about 3 minutes so we can avoid injury to it thyroid gland lose its stain in about 15 minutes so we can remove any residual and decrease residual tissue or recurrence', 'armGroupLabels': ['Intraoperative Spraying Methylene Blue In Thyroidectomy']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mohamed Ahmed Orabi, Specialist Surgical Oncology', 'role': 'CONTACT', 'email': 'Mohamedorabi5885@gmail.com', 'phone': '+2 01001868637'}, {'name': 'Amr M Makky, Specialist Surgical Oncology', 'role': 'CONTACT', 'email': 'Amr.mostafa.makky@gmail.com', 'phone': '+2 010222339139'}], 'overallOfficials': [{'name': 'Remon Elia Lukas, Specialist Surgical Oncology', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Qena Oncology Center'}, {'name': 'Mohamed Taha Mousa, Resident Surgical Oncology', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Qena Oncology Center'}, {'name': 'Mina Romany Tawfeek, Specialist General Surgery', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Qena Oncology Center'}, {'name': 'Abdullah Atyah Ali, Ass.Lecture General Surgery', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Qena Oncology Center--Luxor University'}, {'name': 'Ali Hassan, Resident General Surgery', 'role': 'STUDY_CHAIR', 'affiliation': 'Qena Oncology Center --Qena University'}, {'name': 'Mohamed Ahmed Orabi, Specialist Surgical Oncology', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Qena Oncology Center'}, {'name': 'Amr M Makky, Specialist Surgical Oncology', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Qena Oncology Center- Medical Military Academy'}, {'name': 'Mostafa Sayedd Abd el Rahaman, Resident Surgical Oncology', 'role': 'STUDY_CHAIR', 'affiliation': 'Qena Oncology Center'}, {'name': 'Mena Zarief Malaty, Resident General Surgery', 'role': 'STUDY_CHAIR', 'affiliation': 'Qena Oncology Center--Nag hammady Hospital'}, {'name': 'Hussein El Lithy, Resident General Surgery', 'role': 'STUDY_CHAIR', 'affiliation': 'Qena Oncology Center--Qena General Hospital'}, {'name': 'Abobakr Mohammed, Resident General Surgery', 'role': 'STUDY_CHAIR', 'affiliation': 'Qena Oncology Center--Qena General Hospital'}, {'name': 'Mohamed Mahmoud El Zeer, Resident General Surgery', 'role': 'STUDY_CHAIR', 'affiliation': 'Qena Oncology Center- Sohag University'}, {'name': 'Mahmoud Rabeea Ahmed, Resident General Surgery', 'role': 'STUDY_CHAIR', 'affiliation': 'Qena Oncology Center-Aswan University'}, {'name': 'Mohamed Abouelmagd Salem, Prof. Surgical Oncology', 'role': 'STUDY_CHAIR', 'affiliation': 'Qena Oncology Center-ٍSouth Egypt Center Institute Assiut University'}, {'name': 'Mohamed Saeed Ayaty, Ass.Prof. Surgical Oncology', 'role': 'STUDY_CHAIR', 'affiliation': 'Qena Oncology Center-National Cancer Institute Cairo University'}, {'name': 'Mohamed H Mahran, Ass.Prof. Surgical Oncology', 'role': 'STUDY_CHAIR', 'affiliation': 'Qena Oncology Center-ٍSouth Egypt Center Institute Assiut University'}, {'name': 'Mohamed Hasan Abdel-Aal, Director of QOC', 'role': 'STUDY_CHAIR', 'affiliation': 'Qena Oncology Center'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'about 1year', 'ipdSharing': 'YES', 'description': 'Impact of Intraoperative Spraying methylene blue thyroidectomy'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qena Oncology Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'specialist of Surgical Oncology', 'investigatorFullName': 'Mohamed Ahmed Orabi', 'investigatorAffiliation': 'Qena Oncology Center'}}}}