Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-26 @ 2:34 AM
Study NCT ID:
NCT06291402
Status:
RECRUITING
Last Update Posted:
2024-07-31
First Post:
2024-02-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nasal Packing Duration and Development of Pharyngitis After Septorhinoplasty Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012220', 'term': 'Rhinitis'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-30', 'studyFirstSubmitDate': '2024-02-26', 'studyFirstSubmitQcDate': '2024-02-26', 'lastUpdatePostDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sore throat', 'timeFrame': '48 hours postoperatively', 'description': 'The incidence of Sore throat will be graded as 0 = Nil, 1 = Mild, 2 = Moderate and 3 = Severe as possible.'}], 'secondaryOutcomes': [{'measure': 'Dysphagia', 'timeFrame': '48 hours postoperatively', 'description': 'The incidence of Dysphagia will be recorded'}, {'measure': 'Throat irritation', 'timeFrame': '48 hours postoperatively', 'description': 'The incidence of throat irritation will be recorded'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rhinitis']}, 'descriptionModule': {'briefSummary': 'Septoplasty or septal reconstruction is a corrective surgical procedure performed to straighten the nasal septum. It may be associated with numerous complications. To minimize these complications, both nasal cavities are frequently packed with different types of nasal packing. In our study we will try to find relationship between duration of nasal packing and postrhinoplasty sore throat and pharyngitis.', 'detailedDescription': 'Nasal packing affects swallowing by different mechanisms. It may affect swallowing as a result of nasal congestion, constant mouth breathing, throat dryness and pharyngitis.\n\nPostoperative sore throat causes patient dissatisfaction and poor pain control. Several interventions could be performed to reduce sore throat and pharyngitis and increase patient satisfaction , which may not be convenient for all patients, such as gargling or sprays'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '100 ASA I and II patients aged from 20 to 40 years old will undergo septorhinoplasty in Benha university hospitals', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA I and II patients\n* aged from 20 to 40 years old\n* undergo septorhinoplasty\n\nExclusion Criteria:\n\n* Bleeding disorders\n* Uncontrolled hypertension\n* Cardiovascular diseases\n* Uncontrolled diabetes mellitus\n* Collagen disorders\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT06291402', 'briefTitle': 'Nasal Packing Duration and Development of Pharyngitis After Septorhinoplasty Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Al-Azhar University'}, 'officialTitle': 'Nasal Packing Duration and Its Role in the Development of Pharyngitis After Septorhinoplasty Surgery: A Prospective Observational Study', 'orgStudyIdInfo': {'id': 'RC 34-1-2024'}}, 'contactsLocationsModule': {'locations': [{'zip': '11865', 'city': 'Tanta', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Neveen Kohaf, Ph.D', 'role': 'CONTACT', 'email': 'nevenabdo@azhar.edu.eg', 'phone': '+201060383012'}, {'name': 'Haney Bauiomy, M.D', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ahmed Abosakaya, M.D', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Neveen Kohaf', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'centralContacts': [{'name': 'Neveen Kohaf, Ph.D', 'role': 'CONTACT', 'email': 'nevenabdo@azhar.edu.eg', 'phone': '+201060383012'}, {'name': 'Neveen Kohaf', 'role': 'CONTACT', 'email': 'nevenabdo@azhar.edu.eg', 'phone': '+201060383012'}], 'overallOfficials': [{'name': 'Neveen Kohaf, ph.d', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Al-Azhar University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'ipdSharing': 'YES', 'description': 'Data will be shared upon reasonable request from the principle investigator'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al-Azhar University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Benha University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Clinical Pharmacy', 'investigatorFullName': 'Neveen Abd El Maksoad Kohaf', 'investigatorAffiliation': 'Al-Azhar University'}}}}