Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
Study NCT ID:
NCT05280912
Status:
COMPLETED
Last Update Posted:
2023-05-12
First Post:
2022-02-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Factors Associated With The Risk of Post Tonsillectomy Hemorrhage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-02-08', 'releaseDate': '2023-05-28'}], 'estimatedResultsFirstSubmitDate': '2023-05-28'}}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-11', 'studyFirstSubmitDate': '2022-02-18', 'studyFirstSubmitQcDate': '2022-03-14', 'lastUpdatePostDateStruct': {'date': '2023-05-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'new scoring system for possibility of post tonsillectomy bleeding', 'timeFrame': 'after 4 weeks post tonsillectomy', 'description': 'investigators give a degree to the participants based on the factors they have as age and sex and accompanying to post tonsillectomy bleeding as increase white blood cells and anemia'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bleeding Following Tonsillectomy (Disorder)']}, 'referencesModule': {'references': [{'pmid': '29622331', 'type': 'RESULT', 'citation': 'Wall JJ, Tay KY. Postoperative Tonsillectomy Hemorrhage. Emerg Med Clin North Am. 2018 May;36(2):415-426. doi: 10.1016/j.emc.2017.12.009. Epub 2018 Feb 10.'}], 'seeAlsoLinks': [{'url': 'https://europepmc.org/abstract/MED/10969475', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'factors associated with increase risk of post tonsillectomy hemorrhage and score of associated factors', 'detailedDescription': 'investigators review the medical records of patients who underwent tonsillectomy with or without adenoidectomy in our facility. None of the included patients had any known coagulopathy. The surgery was performed by several different surgeons, either otolaryngology residents or specialists, and using either cold or bipolar dissection. The procedures were performed under general anesthesia with orotracheal intubation. Bipolar electrocoagulation was used for hemostasis, as well as in some cases vicryl sutures. All medical records were reviewed according to age, gender, indications for tonsillectomy (tonsil hypertrophy causing upper airway obstruction, snoring or sleep apnea, chronic tonsillitis, peritonsillar abscess or suspected malignancy of the tonsils), coagulation profile \\[international normalized ratio (INR) and activated partial thromboplastin time values (aPTT)\\], type of surgery (tonsillectomy alone or adenotonsillectomy), surgical technique (cold or bipolar dissection), hemostasis method (bipolar electrocoagulation alone or electrocoagulation and sutures) and post-operative hemorrhage and its characterization. In this report, investigators will evaluate patients and collection of data to make a new scoring system that assesses patients according to several preoperative and postoperative factors to know the possibility of patients developing Post tonsillectomy hemorrhage. Post tonsillectomy hemorrhage is divided into two groups according to its severity: minimal hemorrhage that stopped spontaneously/after noninvasive treatment, and hemorrhage requiring reoperation for hemostasis revision in the operating room under general anesthesia.\n\nPostoperative hemorrhage was defined as any bleeding requiring in hospital observation or treatment (medical, compression, cauterization under general anesthesia). Patients who did not seek medical attention (e.g., patients with blood-tinged sputum or only minor bleeding) were not included in the group with post-operative hemorrhage'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All cases complicated by post-tonsillectomy bleeding', 'healthyVolunteers': False, 'eligibilityCriteria': '* Inclusion criteria : All cases complicated by post-tonsillectomy bleeding\n\n 1. after elective or emergency tonsillectomy\n 2. Primary Hge or secondary Hge\n 3. regardless of age, the indication of surgery, surgical techniques\n* Exclusion criteria:\n\n 1. patient who have preoperative inherited bleeding disorder\n 2. Patients who did not seek medical attention (e.g., patients with blood-tinged sputum or only minor bleeding) riteria:'}, 'identificationModule': {'nctId': 'NCT05280912', 'briefTitle': 'Factors Associated With The Risk of Post Tonsillectomy Hemorrhage', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Factors Associated With The Risk of Post Tonsillectomy Hemorrhage', 'orgStudyIdInfo': {'id': 'HGMohamed'}}, 'contactsLocationsModule': {'locations': [{'city': 'Sohag', 'country': 'Egypt', 'facility': 'Hadir Gamal Mohamed', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'overallOfficials': [{'name': 'waleed AH mohammed, professor', 'role': 'STUDY_CHAIR', 'affiliation': 'sohag faculty of medicine'}, {'name': 'mohamed ER ahmed, doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'sohag faculty of medicine'}, {'name': 'khaled G dahy, doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'sohag faculty of medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'resident of otorhinolaryngology', 'investigatorFullName': 'Hadeer Gamal Mohamed', 'investigatorAffiliation': 'Sohag University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-05-28', 'type': 'RELEASE'}, {'date': '2024-02-08', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Hadeer Gamal Mohamed, resident of otorhinolaryngology, Sohag University'}}}}