Ignite Creation Date:
2025-12-26 @ 5:23 PM
Ignite Modification Date:
2025-12-26 @ 5:23 PM
Study NCT ID:
NCT04905706
Status:
RECRUITING
Last Update Posted:
2025-05-09
First Post:
2021-05-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
3D Laparoscopic Adrenalectomies for Adrenal Tumors
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': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2033-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-06', 'studyFirstSubmitDate': '2021-05-14', 'studyFirstSubmitQcDate': '2021-05-26', 'lastUpdatePostDateStruct': {'date': '2025-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2033-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative complications rate of 3D laparoscopic adrenalectomy', 'timeFrame': 'Within 30 days after surgery', 'description': 'Rate of medical and surgical complications within 30 days after surgery using the Dindo-Clavien classification, described as:\n\nGrade I = Any deviation from the normal postoperative course. Grade 2 = Requiring pharmacological treatment with drugs other than such allowed for grade I complications.\n\nGrade III = Requiring surgical, endoscopic or radiological intervention, not under (Grade IIIa) or under general anesthesia (Grade IIIb) Grade IV = Life-threatening complication with single organ (Grade IVa) or Multiorgan dysfunction (Grade IVb) Grade V = Death of a patient.'}, {'measure': 'Length of hospital stay', 'timeFrame': 'Up to 4 weeks', 'description': 'Total length of hospital stay will be recorded in days beginning at admission for surgery until discharge (number of days) .'}], 'secondaryOutcomes': [{'measure': 'Conversion rate trough 3D laparoscopic adrenalectomy', 'timeFrame': 'Intraoperatively', 'description': 'Conversion to open surgery (Yes vs No).'}, {'measure': 'Intraoperative bleeding during 3D laparoscopic adrenalectomy', 'timeFrame': 'Intraoperatively', 'description': 'Blood loss during surgery (millilitres)'}, {'measure': 'Operative time trough 3D laparoscopic adrenalectomy', 'timeFrame': 'Intraoperatively', 'description': 'Duration of intervention (minutes)'}, {'measure': 'Routine use of abdominal drainage in 3D laparoscopic adrenalectomy', 'timeFrame': 'Intraoperatively', 'description': 'Use of abdominal drainage intraoperatively (Yes vs No).'}, {'measure': 'Comparison of morbidity between obese and non obese patients operated by 3D laparoscopic system', 'timeFrame': 'Within 30 days after surgery', 'description': 'No obese: \\<30 kg/m2 Obese: ≥30 kg/m2'}, {'measure': 'Comparison of morbidity in patients with prior abdominal surgery versus non operated by 3D laparoscopic system', 'timeFrame': 'Within 30 days after surgery', 'description': 'Prior abdominal surgery (Yes vs No).'}, {'measure': 'Comparison of morbidity between elderly and young patients operated by 3D laparoscopic system', 'timeFrame': 'Within 30 days after surgery', 'description': 'Young \\<65 years, Elderly ≥65 years'}, {'measure': 'Comparison of morbidity between American Society of Anesthesiologists I+II and III+IV operated by 3D laparoscopic system', 'timeFrame': 'Within 30 days after surgery', 'description': 'ASA I A normal healthy patient ASA II A patient with mild systemic disease ASA III A patient with severe systemic disease ASA IV A patient with severe systemic disease that is a constant threat to life ASA V A moribund patient who is not expected to survive without the operation ASA VI A declared brain-dead patient whose organs are being removed for donor purposes'}, {'measure': 'Comparison of morbidity between adrenal mass size <6 cm versus ≥6 cm operated by 3D laparoscopic system', 'timeFrame': 'Within 30 days after surgery', 'description': 'Adrenal mass \\<6 cm, Adrenal mass ≥6 cm'}, {'measure': 'Comparison of adrenal mass diagnosis operated by 3D laparoscopic system', 'timeFrame': 'Within 30 days after surgery', 'description': "Incidentaloma, Aldosteronoma, Pheochromocytoma, Cushing's Adenoma and malignant adrenal tumors (primary or metastasis)"}, {'measure': 'Comparison of adrenal mass laterality operated by 3D laparoscopic system', 'timeFrame': 'Within 30 days after surgery', 'description': 'Right adrenal mass, left adrenal mass'}, {'measure': 'Comparison of morbidity between 2D versus 3D laparoscopic system', 'timeFrame': 'Within 30 days after surgery', 'description': 'Conversion (Yes vs No), operative time (min), bleeding (ml), Clavien-Dindo Classification'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Three-dimensional laparoscopy', 'Adrenal tumors', '3D laparoscopic adrenalectomy'], 'conditions': ['Adrenal Tumor', 'Adrenalectomy; Status']}, 'descriptionModule': {'briefSummary': 'The main drawbacks of conventional 2D laparoscopy are limited depth perception and loss of spatial orientation. High-quality 3D laparoscopy systems might improve surgical outcomes for adrenalectomy.', 'detailedDescription': 'Over recent decades, technological advances such as improved video imaging (high-definition cameras), better instrumentation for dissection and hemostasis, articulating staplers, and optimized operating room lighting have added safety, efficacy, and precision to minimally invasive procedures. However, until recently, laparoscopy required surgeons to operate in a three-dimensional (3D) space with only two-dimensional (2D) images to guide their movements, resulting in a lack of depth perception and loss of spatial orientation that increased the risk of errors, fatigue, operative time, and operating room stress and made the technique difficult to learn.\n\nHigh-quality 3D laparoscopy was developed as an alternative to conventional 2D laparoscopy. Several clinical trials and observational studies have compared surgical outcomes between 2D and 3D laparoscopic systems; however, few clinical studies have examined the usefulness of 3D laparoscopy systems for adrenalectomies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All adult patients (age ≥ 18 years) who underwent a unilateral 3D laparoscopic adrenalectomy for adrenal masses (benign and malignant tumors) from January 2013 to December 2033.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All adult patients (age ≥ 18 years)\n* Patients diagnosed with adrenal masses (benign and malignant tumors)\n* Underwent a unilateral 3D laparoscopic adrenalectomy from January 2013 to December 2033.\n\nExclusion Criteria:\n\n* Emergency surgery.\n* Open adrenalectomy.\n* Bilateral adrenalectomies (open or laparoscopy).\n* Patients who underwent laparoscopic adrenalectomy together with another laparoscopic surgical procedure in the same intervention.\n* Patients without complete follow-up for at least 30 days after hospital discharge.'}, 'identificationModule': {'nctId': 'NCT04905706', 'briefTitle': '3D Laparoscopic Adrenalectomies for Adrenal Tumors', 'organization': {'class': 'OTHER', 'fullName': "Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta"}, 'officialTitle': 'Three-dimensional Laparoscopic Adrenalectomies for Benign and Malignant Adrenal Tumors', 'orgStudyIdInfo': {'id': '2020.141'}}, 'armsInterventionsModule': {'armGroups': [{'label': '3D laparoscopic adrenalectomy', 'description': 'Operations are done with an high definition 3D laparoscopic system (Olympus, Tokyo, Japan); all personnel wear polarized glasses to achieve stereoscopic imaging in the operating room. Dissection is realized using a hybrid energy system (Thunderbeat, Olympus Europe Se \\& Co, Hamburg, Germany).'}]}, 'contactsLocationsModule': {'locations': [{'zip': '17007', 'city': 'Girona', 'state': 'Girona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'José Ignacio Rodríguez-Hermosa, MD, PhD', 'role': 'CONTACT', 'email': 'jirodriguez.girona.ics@gencat.cat', 'phone': '972940256'}], 'facility': 'Hospital Universitari Dr. Josep Trueta de Girona', 'geoPoint': {'lat': 41.98311, 'lon': 2.82493}}], 'centralContacts': [{'name': 'José Ignacio Rodríguez-Hermosa, MD, PhD', 'role': 'CONTACT', 'email': 'jirodriguez.girona.ics@gencat.cat', 'phone': '+34 972 94 02 56'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'José Ignacio Rodríguez-Hermosa', 'investigatorAffiliation': "Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta"}}}}