Ignite Creation Date:
2025-12-24 @ 1:28 PM
Ignite Modification Date:
2025-12-29 @ 11:14 PM
Study NCT ID:
NCT07059195
Status:
RECRUITING
Last Update Posted:
2025-07-10
First Post:
2025-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-Invasive Techniques to Maintain Neck Flexion and Reduce Anastomotic Tension After Tracheal Resection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013537', 'term': 'Sutures'}], 'ancestors': [{'id': 'D053831', 'term': 'Surgical Fixation Devices'}, {'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-01', 'studyFirstSubmitDate': '2025-07-01', 'studyFirstSubmitQcDate': '2025-07-01', 'lastUpdatePostDateStruct': {'date': '2025-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cervical spine flexion', 'timeFrame': '2 years', 'description': 'Maintain Neck Flexion and Reduce Anastomotic Tension After Tracheal Resection'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Maintain Neck Flexion and Reduce Anastomotic Tension After Tracheal Resection']}, 'descriptionModule': {'briefSummary': 'Tracheal surgery represents a relatively recent advancement in the field of thoracic surgery. The trachea has unique anatomical and physiological challenges that historically rendered surgical manipulation both risky and limited. Early interventions involving the trachea were primarily restricted to emergency tracheostomy procedures, typically performed as life-saving measures during acute airway obstruction (1). Attempts at tracheal reconstruction were largely unsuccessful due to the absence of suitable anesthesia, inadequate surgical tools, and the prevailing belief that tracheal cartilage lacked sufficient regenerative. As a result, tracheal resection and reconstruction were long considered unfeasible (2).\n\nThe modern era of tracheal surgery began to take shape in the mid-20th century. While early attempts at tracheal resection were performed with limited success, it was the pioneering work of Dr. Hermes C. Grillo in the 1960s that truly transformed the field. Through systematic study of tracheal anatomy, vascular supply, and biomechanics, Dr. Grillo developed standardized and safe techniques for segmental tracheal resection followed by primary end-to-end anastomosis. His work demonstrated that segmental resection of the trachea followed by primary end-to-end anastomosis was feasible and safe (3)(4).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All pediatric and adult patients undergoing tracheal and cricotracheal resection for benign air way stenosis\n* All pediatric and adult patients undergoing tracheal and cricotracheal resection for malignant pathologies\n\nExclusion Criteria:\n\n* patients with previous cervical spine surgery.\n* Congenital or acquired spinal deformities.'}, 'identificationModule': {'nctId': 'NCT07059195', 'briefTitle': 'Non-Invasive Techniques to Maintain Neck Flexion and Reduce Anastomotic Tension After Tracheal Resection', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Non-Invasive Techniques to Maintain Neck Flexion and Reduce Anastomotic Tension After Tracheal Resection', 'orgStudyIdInfo': {'id': 'Soh-Med-25-6--2MD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '• Group A (Non-invasive group)', 'description': 'Patients in this group will have postoperative cervical spine flexion maintained using non-invasive techniques, such as a cervical collar or cervical-thoracic orthosis.', 'interventionNames': ['Procedure: cervical collar or cervical-thoracic orthosis.']}, {'type': 'ACTIVE_COMPARATOR', 'label': '• Group B (Conventional group)', 'description': 'Patients in this group will have cervical spine flexion maintained using traditional chin-to-chest (Grillo) suturing', 'interventionNames': ['Device: chin-to-chest (Grillo) suturing']}], 'interventions': [{'name': 'cervical collar or cervical-thoracic orthosis.', 'type': 'PROCEDURE', 'description': 'postoperative cervical spine flexion maintained using non-invasive techniques, such as a cervical collar or cervical-thoracic orthosis.', 'armGroupLabels': ['• Group A (Non-invasive group)']}, {'name': 'chin-to-chest (Grillo) suturing', 'type': 'DEVICE', 'description': 'cervical spine flexion maintained using traditional chin-to-chest (Grillo) suturing', 'armGroupLabels': ['• Group B (Conventional group)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sohag', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Magdy M Amin, Professor', 'role': 'CONTACT'}], 'facility': 'Sohag University hospital', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'centralContacts': [{'name': 'Abdelrahman Talal Mahmoud, Assisstent lecturer', 'role': 'CONTACT', 'email': 'abdelrahman_ahmed@med.sohag.edu.eg', 'phone': '01001317023'}, {'name': 'Khaled Mohamed Abdelaal', 'role': 'CONTACT'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assisstent lecturer at cardiothorathic department', 'investigatorFullName': 'Abdelrahman Talal Mahomud', 'investigatorAffiliation': 'Sohag University'}}}}