Ignite Creation Date:
2025-12-25 @ 12:58 AM
Ignite Modification Date:
2026-02-28 @ 8:47 PM
Study NCT ID:
NCT03830593
Status:
COMPLETED
Last Update Posted:
2019-10-10
First Post:
2019-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Laparoscopic Adrenalectomy for Large Adrenal Tumors.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000310', 'term': 'Adrenal Gland Neoplasms'}, {'id': 'D000182', 'term': 'ACTH Syndrome, Ectopic'}], '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'}, {'id': 'D009384', 'term': 'Paraneoplastic Endocrine Syndromes'}, {'id': 'D010257', 'term': 'Paraneoplastic Syndromes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2019-07-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-08', 'studyFirstSubmitDate': '2019-02-02', 'studyFirstSubmitQcDate': '2019-02-04', 'lastUpdatePostDateStruct': {'date': '2019-10-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Operation time', 'timeFrame': 'intraoperative (minute)', 'description': 'time from onset to complete of operation'}, {'measure': 'Blood loss', 'timeFrame': 'intraoperative', 'description': 'amount of bleeding during surgery (milliliter)'}, {'measure': 'hospitalization', 'timeFrame': '1 day', 'description': 'duration of postoperative hospital stay'}, {'measure': 'Complication', 'timeFrame': '1 day', 'description': 'abnormal conditions during or after surgery'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['endocrine surgery; laparoscopic adrenalectomy;'], 'conditions': ['Adrenal Tumor', 'Adrenal Adenoma']}, 'referencesModule': {'references': [{'pmid': '27238874', 'type': 'BACKGROUND', 'citation': 'Huynh KT, Lee DY, Lau BJ, Flaherty DC, Lee J, Goldfarb M. Impact of Laparoscopic Adrenalectomy on Overall Survival in Patients with Nonmetastatic Adrenocortical Carcinoma. J Am Coll Surg. 2016 Sep;223(3):485-92. doi: 10.1016/j.jamcollsurg.2016.05.015. Epub 2016 May 26.'}, {'pmid': '29325527', 'type': 'RESULT', 'citation': 'Conzo G, Gambardella C, Candela G, Sanguinetti A, Polistena A, Clarizia G, Patrone R, Di Capua F, Offi C, Musella M, Iorio S, Bellastella G, Pasquali D, De Bellis A, Sinisi A, Avenia N. Single center experience with laparoscopic adrenalectomy on a large clinical series. BMC Surg. 2018 Jan 11;18(1):2. doi: 10.1186/s12893-017-0333-8.'}]}, 'descriptionModule': {'briefSummary': 'Laparoscopic adrenalectomy is the treatment of choice for the benign tumor of less than 6 cm. However, this is an ongoing debate that exact cut-off value of tumor size for LA. The aim of this study was to assess whether the size of the adrenal tumor affects preoperative and postoperative outcomes in patients undergoing laparoscopic transperitoneal adrenalectomy as well as to evaluate the learning curve.', 'detailedDescription': 'From April 2010 to October 2018, preoperative and postoperative data of 107 patients who underwent LTA with adrenal mass were recorded prospectively and analyzed retrospectively.\n\nThe inclusion criteria were all hormonally active adrenal lesions, detection of increases in size in \\< 4 cm adrenal tumors on serial imaging, solitary adrenal metastases without evidence of local invasion, tumors size ≥ 4 cm, patients between the age of 18 and 80, and American Society of Anesthesiologists score (ASA) ≤ 3. The patients with adrenal masses that specified suspicion of malignancy on imaging such as local invasion, irregular tumor margins were evaluated as ineligible for LTA, and excluded in this study, were addressed to open surgery. Retroperitoneoscopic and laparoscopic partial adrenalectomies were also excluded from the study.\n\nTotally 102 patients were included in the study. The patients were allocated according to adrenal tumor size as \\<6cm (group 1:76) and ≥ 6 cm (group 2: 26). The variables such as demographics, tumor size, and laterality, operation time, blood loss, per-operative and postoperative complications, length of hospital stay, final pathology result were compared between the two groups. In order to evaluate the learning curve, the patients were also classified into three consecutive groups including group A (1-25), group B (25-50), group C (51-75) and group D (76-102) according to the chronological order of their surgery. Variables including operation time, tumor size, blood loss, and hospital stay, and overall complications were used to investigate the learning curve.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'From April 2010 to October 2018, preoperative and postoperative data of 107 patients who underwent laparoscopic adrenalectomy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. all hormonally active adrenal lesions,\n2. detection of increases in size in \\< 4 cm adrenal tumors on serial imaging,\n3. solitary adrenal metastases without evidence of local invasion,\n4. tumors size ≥ 4 cm,\n5. patients between the age of 18 and 80\n6. American Society of Anesthesiologists score (ASA) ≤ 3.\n\nExclusion Criteria:\n\n1. suspicion of malignancy on imaging such as local invasion, irregular tumor margins\n2. Retroperitoneoscopic adrenalectomies\n3. laparoscopic partial adrenalectomies'}, 'identificationModule': {'nctId': 'NCT03830593', 'briefTitle': 'Laparoscopic Adrenalectomy for Large Adrenal Tumors.', 'organization': {'class': 'OTHER', 'fullName': 'Samsun Liv Hospital'}, 'officialTitle': 'Is There Anything New in the Field of Large Adrenal Tumors ?', 'orgStudyIdInfo': {'id': 'OMU KAEK (2019/78)'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'laparoscopic adrenalectomy group 1: tumor size as \\< 6 (group1)', 'interventionNames': ['Procedure: Laparoscopic Adrenalectomy']}, {'label': 'Group 2', 'description': 'Laparoscopic adrenalectomy group2: tumor size ≥ 6 cm (group2)', 'interventionNames': ['Procedure: Laparoscopic Adrenalectomy']}, {'label': 'Learning Curve', 'description': 'The patients, underwent laparoscopic adrenalectomy, were also classified into group A (1-25), B (26-50), C (51-75), and D (76-102) according to the chronological order of their surgery in order to evaluate the learning curve.', 'interventionNames': ['Procedure: Laparoscopic Adrenalectomy']}], 'interventions': [{'name': 'Laparoscopic Adrenalectomy', 'type': 'PROCEDURE', 'description': 'minimally invasive lateral transperitoneal adrenalectomy', 'armGroupLabels': ['Group 1', 'Group 2', 'Learning Curve']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55020', 'city': 'Samsun', 'country': 'Turkey (Türkiye)', 'facility': 'Samsun Liv Hospital', 'geoPoint': {'lat': 41.27976, 'lon': 36.3361}}, {'zip': '55030', 'city': 'Samsun', 'country': 'Turkey (Türkiye)', 'facility': 'Ondokuz Mayıs University', 'geoPoint': {'lat': 41.27976, 'lon': 36.3361}}], 'overallOfficials': [{'name': 'Şaban Sarıkaya, Prof. MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Ondokuz Mayıs University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsun Liv Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ondokuz Mayıs University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Mehmet Necmettin Mercimek', 'investigatorAffiliation': 'Samsun Liv Hospital'}}}}