Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2025-12-26 @ 9:25 AM
Study NCT ID:
NCT06050057
Status:
RECRUITING
Last Update Posted:
2023-09-22
First Post:
2023-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surgical Treatment of Adrenal Diseases- Laparoscopic vs. Robotic-assisted Adrenalectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000310', 'term': 'Adrenal Gland Neoplasms'}, {'id': 'D000307', 'term': 'Adrenal Gland Diseases'}, {'id': 'D000312', 'term': 'Adrenal Hyperplasia, Congenital'}, {'id': 'D000303', 'term': 'Adrenal Cortex Diseases'}, {'id': 'D010673', 'term': 'Pheochromocytoma'}, {'id': 'D003480', 'term': 'Cushing Syndrome'}, {'id': 'D018246', 'term': 'Adrenocortical Adenoma'}, {'id': 'D018268', 'term': 'Adrenocortical Carcinoma'}, {'id': 'D000306', 'term': 'Adrenal Cortex Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D047808', 'term': 'Adrenogenital Syndrome'}, {'id': 'D012734', 'term': 'Disorders of Sex Development'}, {'id': 'D014564', 'term': 'Urogenital Abnormalities'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D043202', 'term': 'Steroid Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D010235', 'term': 'Paraganglioma'}, {'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D000308', 'term': 'Adrenocortical Hyperfunction'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-17', 'studyFirstSubmitDate': '2023-09-04', 'studyFirstSubmitQcDate': '2023-09-17', 'lastUpdatePostDateStruct': {'date': '2023-09-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Initial examination 1', 'timeFrame': '1 day', 'description': 'Initial examination by a urologist and indication for the surgery.'}, {'measure': 'Initial examination 2', 'timeFrame': '1 day', 'description': 'Sampling of biological material: Hemoglobin g/l'}, {'measure': 'Surgical period 1', 'timeFrame': '1 day', 'description': 'Measuring the operation time in minutes.'}, {'measure': 'Surgical period 2', 'timeFrame': '1 day', 'description': 'Measuring the blood loss in milliliters (ml).'}, {'measure': 'Surgical period 3', 'timeFrame': '1 day', 'description': 'Record the need for conversion to open surgery.'}, {'measure': 'Surgical period 4', 'timeFrame': '1 day', 'description': 'Record the surgical complications.'}, {'measure': 'Surgical period 5', 'timeFrame': '1 day', 'description': 'The consumption of special surgical instruments.'}, {'measure': 'Perioperative period 1', 'timeFrame': 'from 3- 7 days', 'description': 'Perioperatively, the length of stay in the ICU in days.'}, {'measure': 'Perioperative period 2', 'timeFrame': 'from 3- 7 days', 'description': 'Perioperatively, total hospitalization time in days'}, {'measure': 'Perioperative period 3', 'timeFrame': 'from 3- 7 days', 'description': 'Perioperatively, blood loss from the drain in mililiters (ml).'}, {'measure': 'Perioperative period 4', 'timeFrame': 'from 3- 7 days', 'description': 'Perioperatively, time to remove the abdominal drain in days.'}, {'measure': 'Perioperative period 5', 'timeFrame': 'from 3- 7 days', 'description': 'Perioperatively, need for blood substitutes.'}, {'measure': 'Perioperative period 6', 'timeFrame': 'from 3- 7 days', 'description': 'Perioperatively, number of forced surgical revisions.'}, {'measure': 'Perioperative period 7', 'timeFrame': 'from 3- 7 days', 'description': 'Perioperatively, consumption of analgesics during the hospitalization.'}, {'measure': 'First post-operative check-up 1', 'timeFrame': '1 day of examination, 14- 20 days from the surgery', 'description': 'First postoperative visit (14th to 20th postoperative day), sampling of biological material: Hemoglobin g/l'}, {'measure': 'First post-operative check-up 2', 'timeFrame': '1 day of examination, 14- 20 days from the surgery', 'description': 'First postoperative visit (14th to 20th postoperative day)- an analysis of perioperative and early postoperative complications according to the Dindo Clavien classification'}, {'measure': 'First post-operative check-up 3', 'timeFrame': '1 day of examination, 14- 20 days from the surgery', 'description': 'First postoperative visit (14th to 20th postoperative day)- necessary hospitalizations and operative revisions.'}, {'measure': 'Second post-operative check-up 1', 'timeFrame': '1 day of examination, 85-100 days from the surgery', 'description': 'Second postoperative visit (85th to 100th postoperative day)- an analysis of late postoperative complications according to the Dindo Clavien classification.'}, {'measure': 'Second post-operative check-up 2', 'timeFrame': '1 day of examination, 85-100 days from the surgery', 'description': 'Second postoperative visit (85th to 100th postoperative day)- necessary hospitalizations and operative revisions'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Adrenal Tumor', 'Pheochromocytoma', 'Conn Adenoma', 'Cushing Syndrome', 'Adrenalectomy', 'Laparoscopic surgery', 'da Vinci surgical system'], 'conditions': ['Adrenal Tumor', 'Adrenal Disease', 'Adrenal Mass', 'Adrenalectomy; Status', 'Adrenal Hyperplasia', 'Adrenal Gland Metastasis', 'Adrenal Cortex Diseases', 'Pheochromocytoma', 'Cushing Syndrome', 'Conn Adenoma', 'Adrenocortical Carcinoma', 'Adrenocortical Adenoma', 'Adrenocortical Tumor']}, 'descriptionModule': {'briefSummary': 'The goal of this multicenter, observational, analytic, randomized clinical trial is to analyze the laparoscopic and robot-assisted method in the surgical treatment of patients with adrenal diseases. The main question it aims to answer are:\n\n1. to find the superiority of one the the surgical method mentioned above\n2. to compare the quality of life in patients with adrenal mass before surgery and after laparoscopic or robotic-assisted adrenalectomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients indicated for adrenalectomy based on endocrinological and imaging examination. All patients older than 18 years who met the clinical criteria.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Indicated adrenalectomy based on endocrinological and imaging examination.\n* Written consent to participate in the study.\n\nExclusion Criteria:\n\n* Simultaneous bilateral adrenalectomy.\n* Adrenal expansion \\> 12 cm.\n* Suspected malignant adrenal tumor with infiltrative growth or tumor venous thrombus according to imaging examination.'}, 'identificationModule': {'nctId': 'NCT06050057', 'briefTitle': 'Surgical Treatment of Adrenal Diseases- Laparoscopic vs. Robotic-assisted Adrenalectomy', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Olomouc'}, 'officialTitle': 'Possibilities of Surgical Treatment of Adrenal Diseases: Comparison of Laparoscopic and Robotic-assisted Adrenalectomy-a Prospective Study', 'orgStudyIdInfo': {'id': 'FNOL 122/23'}}, 'contactsLocationsModule': {'locations': [{'zip': '77900', 'city': 'Olomouc', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Igor Hartmqnn, MD, PhD', 'role': 'CONTACT', 'email': 'igor.hartmann@fnol.cz', 'phone': '+420588442895'}, {'name': 'Natalia Wiesner, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Igor Hartmann, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University hospital Olomouc', 'geoPoint': {'lat': 49.59552, 'lon': 17.25175}}], 'centralContacts': [{'name': 'MUDr. Igor Hartmann Ph.D.', 'role': 'CONTACT', 'email': 'Igor.Hartmann@fnol.cz', 'phone': '+420588442895'}, {'name': 'Natalia Wiesner', 'role': 'CONTACT', 'email': 'natalia.wiesner@fnol.cz', 'phone': '+420588445709'}], 'overallOfficials': [{'name': 'MUDr. Igor Hartmann Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Dpt. of Urology, University hospital Olomouc'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Olomouc', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital Ostrava', 'class': 'OTHER'}, {'name': 'Tomas Bata Hospital, Czech Republic', 'class': 'OTHER'}, {'name': 'General University Hospital, Prague', 'class': 'OTHER'}, {'name': 'University Hospital Hradec Kralove', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of the urological clinic, MUDr. Igor Hartmann Ph.D.', 'investigatorFullName': 'Natalia Wiesner', 'investigatorAffiliation': 'University Hospital Olomouc'}}}}