Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2025-12-27 @ 8:34 AM
Study NCT ID:
NCT04615494
Status:
COMPLETED
Last Update Posted:
2021-01-26
First Post:
2020-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Internal Carotid Artery Blood Flow in Robot-Assisted Laparoscopic Prostatectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D056888', 'term': 'Patient Positioning'}], 'ancestors': [{'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2021-01-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-25', 'studyFirstSubmitDate': '2020-11-03', 'studyFirstSubmitQcDate': '2020-11-03', 'lastUpdatePostDateStruct': {'date': '2021-01-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in internal carotid artery blood flow', 'timeFrame': 'At 10 minutes after pneumoperitoneum with steep Trendelenburg position', 'description': 'Difference between the internal carotid artery blood flow measured at 10 minutes after anesthetic induction during supine position and the internal carotid artery blood flow measured at 10 minutes after pneumoperitoneum with steep Trendelenburg position'}], 'secondaryOutcomes': [{'measure': 'Internal carotid artery blood flow', 'timeFrame': 'Baseline (Before anesthetic induction)', 'description': 'Internal carotid artery blood flow before anesthetic induction'}, {'measure': 'Internal carotid artery blood flow', 'timeFrame': 'At 10 minutes after anesthetic induction', 'description': 'Internal carotid artery blood flow at 10 minutes after anesthetic induction'}, {'measure': 'Internal carotid artery blood flow', 'timeFrame': 'At 10 minutes after pneumoperitoneum and Trendelenburg position', 'description': 'Internal carotid artery blood flow at 10 minutes after pneumoperitoneum and Trendelenburg position'}, {'measure': 'Internal carotid artery blood flow', 'timeFrame': 'At 30 minutes after pneumoperitoneum and Trendelenburg position', 'description': 'Internal carotid artery blood flow at 30 minutes after pneumoperitoneum and Trendelenburg position'}, {'measure': 'Internal carotid artery blood flow', 'timeFrame': 'Procedure (At skin closure)', 'description': 'Internal carotid artery blood flow during supine position at skin closure'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the change of the internal carotid artery blood flow according to the steep trendelenburg position and pneumoperitoneum in patients undergoing robot-assisted laparoscopic prostatectomy.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who have undergone robot-assisted laparoscopic prostatectomy with prostate cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who have undergone robot-assisted laparoscopic prostatectomy with prostate cancer and who are 20 years or older and under 80 years\n* Patients who agree to voluntarily participate in this study\n* Patients with ASA class 1-2\n\nExclusion Criteria:\n\n* History of diagnosis of cerebrovascular disease\n* Patients who refused to participate in clinical studies'}, 'identificationModule': {'nctId': 'NCT04615494', 'briefTitle': 'Internal Carotid Artery Blood Flow in Robot-Assisted Laparoscopic Prostatectomy', 'organization': {'class': 'OTHER', 'fullName': 'Asan Medical Center'}, 'officialTitle': 'Change of Internal Carotid Artery Blood Flow During Pneumoperitoneum With Steep Trendelenburg Position in Robot-Assisted Laparoscopic Prostatectomy', 'orgStudyIdInfo': {'id': '2020-1638'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Position', 'type': 'PROCEDURE', 'description': 'Pneumoperitoneum with Steep Trendelenburg position'}]}, 'contactsLocationsModule': {'locations': [{'zip': '05505', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Young-Kug Kim, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Asan Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asan Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Young-Kug Kim, MD', 'investigatorAffiliation': 'Asan Medical Center'}}}}