Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2026-01-01 @ 12:54 PM
Study NCT ID:
NCT06330558
Status:
COMPLETED
Last Update Posted:
2024-03-28
First Post:
2024-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Side-specific Factors for Conversion in Adrenalectomy for Pheochromocytoma.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000310', 'term': 'Adrenal Gland Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D000307', 'term': 'Adrenal Gland Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 271}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-26', 'studyFirstSubmitDate': '2024-03-19', 'studyFirstSubmitQcDate': '2024-03-19', 'lastUpdatePostDateStruct': {'date': '2024-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'conversion', 'timeFrame': 'intraoperative', 'description': 'number of conversion'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Adrenal Tumor']}, 'descriptionModule': {'briefSummary': 'Context: Adrenalectomy for pheochromocytoma (PHEO) poses difficulties due to the elevated chance of conversion. The objective of this study was to conduct a comparative analysis of the occurrence and determinants of conversion in left-sided abdominal laparoscopic adrenalectomy (LLA) and right-sided abdominal laparoscopic adrenalectomy (RLA).\n\nMethods: A retrospective analysis was conducted to include a total of 271 patients diagnosed with PHEO. These patients were separated into two groups: LRA (N=121) and LLA (N=150). The study period spanned from September 2016 to September 2023.', 'detailedDescription': 'The process of performing an adrenalectomy for pheochromocytoma (PHEO) is difficult due to the significant risk of conversion. The objective of this study was to conduct a comparative analysis of the occurrence and determinants of conversion in left-sided abdominal laparoscopic adrenalectomy (LLA) and right-sided abdominal laparoscopic adrenalectomy (RLA).\n\nMethods: A retrospective analysis was conducted to include a total of 271 patients diagnosed with PHEO. These patients were separated into two groups: LRA (N=121) and LLA (N=150). The study period spanned from September 2016 to September 2023.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'An analysis of individuals who have undergone TLA and have unilateral PHEO of any size, aged over 18 years, and of both sexes.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Unilateral pheochromocytoma of any size, over 18 years old, both males and females\n\nExclusion Criteria:\n\n* Patients undergoing initial open adrenalectomy, - Additional surgical interventions during total laparoscopic adrenalectomy, - Partial adrenalectomy,\n\nBilateral PHEOS. Hemorrhagic diathesis, Structural deformity Pregnancy,\n\n\\- Prior unilateral abdominal surgery, data is absent. The preoperative diagnosis is ambiguous. Hereditary (PHEO), or recurrent PHEO'}, 'identificationModule': {'nctId': 'NCT06330558', 'briefTitle': 'Side-specific Factors for Conversion in Adrenalectomy for Pheochromocytoma.', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Zagazig University'}, 'officialTitle': 'Side-specific Factors for Conversion in Adrenalectomy for Pheochromocytoma. A Comparative Analysis', 'orgStudyIdInfo': {'id': 'pheos'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'group A', 'description': 'laparoscopic right adrenalectomy', 'interventionNames': ['Procedure: laparoscopic right adrenalectomy']}, {'label': 'Group B', 'description': 'laparoscopic left adrenalectomy', 'interventionNames': ['Procedure: laparoscopic right adrenalectomy']}], 'interventions': [{'name': 'laparoscopic right adrenalectomy', 'type': 'PROCEDURE', 'description': 'adrenalectomy', 'armGroupLabels': ['Group B', 'group A']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zagazig University', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professour of general and laparoscopic surgery', 'investigatorFullName': 'Tamer.A.A.M.Habeeb', 'investigatorAffiliation': 'Zagazig University'}}}}