Ignite Creation Date:
2025-12-24 @ 12:34 PM
Ignite Modification Date:
2026-02-25 @ 5:49 PM
Study NCT ID:
NCT02025361
Status:
COMPLETED
Last Update Posted:
2018-01-18
First Post:
2013-12-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Local Anesthesia Type on Cancer Detection Rate in Transrectal Ultrasound Guided Prostate Biopsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 422}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-16', 'studyFirstSubmitDate': '2013-12-17', 'studyFirstSubmitQcDate': '2013-12-30', 'lastUpdatePostDateStruct': {'date': '2018-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-01-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cancer detection rate with anesthesia type', 'timeFrame': 'finally pathologic evaluation within 2-3 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['prostate biopsy, local anesthesia, cancer detection rate.'], 'conditions': ['Adenocarcinoma of Prostate']}, 'descriptionModule': {'briefSummary': 'Transrectal ultrasound guided prostate biopsy (TRUS-Bx) is the gold standard method for prostat cancer diagnosis. Cancer detection rate is an important issue in TRUS-Bx. Effective biopsy protocol is necessary to enhance cancer detection rate during the procedure. Patient tolerance may improve the protocol effectiveness and quality.\n\nAdequate patient tolerance with optimal local anesthesia may enhance cancer detection rate in TRUS-Bx.', 'detailedDescription': "In transrectal ultrasound guided prostate biopsy ultrasound's probe manipulation is necessary for effective biopsy. Patient discomfort and pain frequently occurs with manipulation of probe during transrectal ultrasound guided prostate biopsy and this situation may qualify of the achievement of this procedure.\n\nIn this study, we aimed to describe the impact of different two local anesthesia types on cancer detection rate in transrectal ultrasound guided prostate biopsy."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who underwent transrectal ultrasound guided prostate biopsy because of elevated serum PSA levels and/or suspicious rectal examination of prostate.\n\nExclusion Criteria:\n\n* Previous TRUS-Bx and prostatic operations(TUR-P, open prostatectomy, etc..) history, treatment for prostate carcinoma, usage of finasteride and dutasteride.'}, 'identificationModule': {'nctId': 'NCT02025361', 'briefTitle': 'Impact of Local Anesthesia Type on Cancer Detection Rate in Transrectal Ultrasound Guided Prostate Biopsy', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Bagcilar Training and Research Hospital'}, 'officialTitle': 'Impact of Local Anesthesia Type on Cancer Detection Rate in Transrectal Ultrasound Guided Prostate Biopsy', 'orgStudyIdInfo': {'id': 'Cancer detection in TRUS-Bx'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intrarectal lidocaine gel', 'description': 'transrectal ultrasound guided prostate biopsy was performed with intrarectal lidocaine gel anesthesia: 10 minutes before the procedure % 2 lidocaine hydrochloride gel instilated into the rectum for local anesthesia', 'interventionNames': ['Drug: intrarectal lidocaine gel']}, {'type': 'EXPERIMENTAL', 'label': 'periprostatic nerve blockade', 'description': 'transrectal ultrasound guided prostate biopsy was performed with intrarectal lidocaine gel anesthesia: 10 minutes before the procedure transrectal ultrasound guided 10 ml prilocaine and serum physiologic blend (5ml %2 prilocaine and 5 ml serum physiologic) injected separetly 5ml right and 5ml left junction between the prostate base and seminal vesicle.', 'interventionNames': ['Drug: periprostatic nerve blockade']}], 'interventions': [{'name': 'intrarectal lidocaine gel', 'type': 'DRUG', 'otherNames': ['No name'], 'description': 'intrarectal local anesthetic application', 'armGroupLabels': ['intrarectal lidocaine gel']}, {'name': 'periprostatic nerve blockade', 'type': 'DRUG', 'otherNames': ['No name'], 'description': 'periprostatic local anesthetic application', 'armGroupLabels': ['periprostatic nerve blockade']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34100', 'city': 'Istanbul', 'state': 'Bagcilar', 'country': 'Turkey (Türkiye)', 'facility': 'Bagcilar Training and Research Hospital-Depertmant of urology', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'mustafa z temiz', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'bagcilar training and research hospital-depertmant of urology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bagcilar Training and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Mustafa Zafer Temiz', 'investigatorAffiliation': 'Bagcilar Training and Research Hospital'}}}}