Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2025-12-25 @ 8:12 PM
Study NCT ID:
NCT00894335
Status:
UNKNOWN
Last Update Posted:
2011-06-28
First Post:
2009-05-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Anesthesia Management of Retroperitoneal Adrenalectomies
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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-05', 'completionDateStruct': {'date': '2012-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-06-27', 'studyFirstSubmitDate': '2009-05-06', 'studyFirstSubmitQcDate': '2009-05-06', 'lastUpdatePostDateStruct': {'date': '2011-06-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Arterial-alveolar Carbon dioxide Difference', 'timeFrame': '3 years'}], 'secondaryOutcomes': [{'measure': 'Perioperative maximal mean arterial pressure', 'timeFrame': '3 Years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['retroperitoneoscopic adrenalectomy', 'intraoperative arterial-alveolar Carbon dioxide Difference'], 'conditions': ['Adrenal Tumors']}, 'referencesModule': {'references': [{'pmid': '17188142', 'type': 'BACKGROUND', 'citation': 'Walz MK, Alesina PF, Wenger FA, Deligiannis A, Szuczik E, Petersenn S, Ommer A, Groeben H, Peitgen K, Janssen OE, Philipp T, Neumann HP, Schmid KW, Mann K. Posterior retroperitoneoscopic adrenalectomy--results of 560 procedures in 520 patients. Surgery. 2006 Dec;140(6):943-8; discussion 948-50. doi: 10.1016/j.surg.2006.07.039.'}]}, 'descriptionModule': {'briefSummary': 'This study is a prospective, perioperative evaluation of hemodynamic and respiratory parameters in patients undergoing retroperitoneoscopic adrenalectomies.', 'detailedDescription': 'Due to their underlying disease, patients with adrenal tumors are prone to episodes of hyper- and hypotension. Furthermore, excessive hypercarbia and an increased arterial-alveolar CO2 difference can be seen during these operations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with adrenal tumors scheduled for retroperitoneal adrenalectomies', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with an adrenal tumor\n\nExclusion Criteria:\n\n* Age below 18 years'}, 'identificationModule': {'nctId': 'NCT00894335', 'briefTitle': 'Anesthesia Management of Retroperitoneal Adrenalectomies', 'organization': {'class': 'OTHER', 'fullName': 'Kliniken Essen-Mitte'}, 'officialTitle': 'Anesthesiological Management of Hemodynamics and Gas Exchange for Retroperitoneal Adrenalectomies', 'orgStudyIdInfo': {'id': 'retroper adrenal'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Pheochromocytoma'}, {'label': '2', 'description': 'Conn-Syndrome'}, {'label': '3', 'description': 'Cushing disease'}, {'label': '4', 'description': 'Metastasis'}, {'label': '5', 'description': 'Non-functional tumor'}]}, 'contactsLocationsModule': {'locations': [{'zip': '45136', 'city': 'Essen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Harald Groeben, Prof, M.D.', 'role': 'CONTACT', 'email': 'h.groeben@kliniken-essen-mitte.de', 'phone': '##49 201 174', 'phoneExt': '31109'}, {'name': 'Harald Groeben, Prof, M.D.', 'role': 'CONTACT', 'email': 'h.groeben@klinken-essen-mitte.de', 'phone': '##49 201 174', 'phoneExt': '31109'}, {'name': 'Harald Groeben, Prof., M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Clinics Essen-Mitte', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}], 'centralContacts': [{'name': 'Harald Groeben, Prof., M.D.', 'role': 'CONTACT', 'email': 'h.groeben@kliniken-essen-mitte.de', 'phone': '##49 201 174', 'phoneExt': '31109'}], 'overallOfficials': [{'name': 'Harald Groeben, Prof, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinics Essen-Mitte'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kliniken Essen-Mitte', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Harald Groeben, Prof. Dr.', 'oldOrganization': 'Department of Anesthesiology and CCM , Clinics Essen-Mitte'}}}}