Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2025-12-31 @ 10:18 PM
Study NCT ID:
NCT03984851
Status:
COMPLETED
Last Update Posted:
2019-06-13
First Post:
2019-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hemostasis Using Surgicel in Pediatric Tonsillectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D016063', 'term': 'Blood Loss, Surgical'}], 'ancestors': [{'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007431', 'term': 'Intraoperative Complications'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 203}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-12', 'studyFirstSubmitDate': '2019-06-11', 'studyFirstSubmitQcDate': '2019-06-12', 'lastUpdatePostDateStruct': {'date': '2019-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Post-operative tonsillectomy bleeding', 'timeFrame': '24 hours post-op', 'description': 'Bleeding due to the surgical procedure within 24 hours from the surgery'}, {'measure': 'Secondary Post-operative Tonsillectomy bleeding', 'timeFrame': 'after 24 hours', 'description': 'Bleeding due to the surgical procedure after 24 hours from the surgery'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['tonsillectomy', 'primary hemostasis tonsillectomy', 'surgicel'], 'conditions': ['Tonsil; Injury', 'Surgical Blood Loss']}, 'descriptionModule': {'briefSummary': 'Tonsillectomy is one of the commonest procedures performed in otolaryngology and one of its major complications is post-tonsillectomy bleeding.\n\nThe goal of this study was to assess the effectiveness of Surgicel without bipolar cautery in achieving primary hemostasis in tonsillectomy. The patient that were enrolled in this retrospective study were patients who underwent tonsillectomy and achieved hemostasis either by Surgicel (group A) or bipolar cautery (group B). Our results showed that there was no statistical significant difference between the two techniques in terms of post-operative bleeding events.', 'detailedDescription': 'Tonsillectomy is one of the commonest procedures performed in otolaryngology and one of its major complications is post-tonsillectomy bleeding.\n\nThe goal of this study was to assess the effectiveness of Surgicel without bipolar cautery in achieving primary hemostasis in tonsillectomy.\n\nThe study was a retrospective cohort in three tertiary care centers in xxxx, from January 2016 to August 2018. All patients underwent at least tonsillectomy, with a proportion undergoing additional adenoidectomy, myringotomy, or tube insertion as indicated, were enrolled in the study. Patients were stratified to 2 groups according to the surgeons preference for the hemostasis technique, one was subjected to cold dissection tonsillectomy and achieved hemostasis via the application of Surgicel to the surgical site, and the other underwent cold dissection tonsillectomy and attained hemostasis through bipolar cautery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'any patient under the age of 12 who underwent tonsillectomy due to either recurrent tonsillitis or OSA by the 3 consultant otolaryngology surgeon authors in the study', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients under age of 12, diagnosed with recurrent tonsillitis or OSA and are candidates for tonsillectomy\n* patients must have went tonsillectomy\n\nExclusion Criteria:\n\n* age more than 12'}, 'identificationModule': {'nctId': 'NCT03984851', 'briefTitle': 'Hemostasis Using Surgicel in Pediatric Tonsillectomy', 'organization': {'class': 'OTHER', 'fullName': 'Dr. Abdul Mohsen Ibrahim Al-Turki Clinic'}, 'orgStudyIdInfo': {'id': 'Al-Terki Clinic'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group A: Surgicel Group', 'description': 'a retrospective cohort study. Two groups were assigned, the first under the care of the author \\[AA\\], in which patients of his group underwent cold dissection tonsillectomy and achieved hemostasis via surgicel (without bipolar cautery). While group B patients (consisted of 2 surgeons) underwent cold dissection tonsillectomy and attained hemostasis with bipolar cautery. The main outcome that was pursued was postoperative tonsillectomy bleeding'}, {'label': 'Group B: Bipolar Cautery group', 'description': 'a retrospective cohort study. Two groups were assigned, the first under the care of the author \\[AA\\], in which patients of his group underwent cold dissection tonsillectomy and achieved hemostasis via surgicel (without bipolar cautery). While group B patients (consisted of 2 surgeons) underwent cold dissection tonsillectomy and attained hemostasis with bipolar cautery. The main outcome that was pursued was postoperative tonsillectomy bleeding'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr. Abdul Mohsen Ibrahim Al-Turki Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Abdulmohsen Al-Terki', 'investigatorFullName': 'Abdulmohsen Al-Terki', 'investigatorAffiliation': 'Dr. Abdul Mohsen Ibrahim Al-Turki Clinic'}}}}