Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2026-02-08 @ 9:58 AM
Study NCT ID:
NCT02293759
Status:
UNKNOWN
Last Update Posted:
2016-03-29
First Post:
2014-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial of HoLEP vs. PVP in Treating BPH in Patients With Bleeding Tendency
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011470', 'term': 'Prostatic Hyperplasia'}], 'ancestors': [{'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2016-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-03-27', 'studyFirstSubmitDate': '2014-11-13', 'studyFirstSubmitQcDate': '2014-11-17', 'lastUpdatePostDateStruct': {'date': '2016-03-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'perioperative blood loss', 'timeFrame': '48 hours'}], 'secondaryOutcomes': [{'measure': 'readmission', 'timeFrame': '30 days'}, {'measure': 'blood transfusion', 'timeFrame': '30 days'}, {'measure': 'flow rate', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['BPH- LASER- PROSTATE- BLEEDING TENDENCY'], 'conditions': ['Benign Prostatic Hyperplasia']}, 'descriptionModule': {'briefSummary': 'Patients presented for BPH surgery at our out patient clinic will be assessed for abnormal bleeding profile.\n\nPatients with bleeding tendency will be offered either HoLEP or Greenlight laser PVP based on prostate size cut off point of 80ml Larger prostates will be treated with HoLEP Smaller prostates will be treated with greenlight PVP', 'detailedDescription': 'Elderly patients with bleeding tendency either secondary;\n\n1. Strict antiplatelet intake\n2. Strict anticoagulant intake\n3. uncorrected natural bleeding tendency e.g; patients with liver cell failure are at higher risk of perioperative bleeding when subjected to prostate surgery.\n\nLaser prostate surery was introduced to overcome this difficulty. However, till now there is no head to head comparision of different types of laser procedures in treating this subset of patients In the current study patients presented for BPH surgery in a tertiarry referral prostate unit will be assessed for bleeding tendency and will be treated either by Holmium laser enucleatiuon of the prostate or Greenlight laser vaporization of the prostate Single surgeon will perform all cases'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BPH patients candidate for transurethral prostate surgery after failure of medical treatment\n* Perioperative uncorrected Blleding tendency\n\n 1. patients with naturally induced uncorrectable bleeding tendency;\n\n 1. platelet count less than 100000/mm3\n 2. INR more than 1.5\n 2. Patients on oral antiplatlet that deemed unsafe to stop prior to surgery as per intenist\n 3. Patients on oral anticoagulant that deemed unsafe to stop prior to surgery as per intenist\n\nExclusion Criteria:\n\n* Correctable bleeding tendency'}, 'identificationModule': {'nctId': 'NCT02293759', 'briefTitle': 'Trial of HoLEP vs. PVP in Treating BPH in Patients With Bleeding Tendency', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Prospective Non-randomized Trial Comparing Holmium Laser Enucleation of the Prostate Versus Greenlight Laser Photoselective Vaporization of the Prostate in Treating Benign Prostate Hyperplasia in Patients With Bleeding Tendency', 'orgStudyIdInfo': {'id': 'Mans-2014-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'HoLEP', 'description': 'Holmium laser enucleation of the prostate', 'interventionNames': ['Procedure: HoLEP']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Greenlight laser PVP', 'description': 'Phtoselective vaporization of the prostate', 'interventionNames': ['Procedure: Greenlight laser PVP']}], 'interventions': [{'name': 'HoLEP', 'type': 'PROCEDURE', 'description': 'Holmium laser enucleation of the prsotate', 'armGroupLabels': ['HoLEP']}, {'name': 'Greenlight laser PVP', 'type': 'PROCEDURE', 'description': 'Greenlight laser (532nm) Photoslective vaporization of the prostate', 'armGroupLabels': ['Greenlight laser PVP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35516', 'city': 'Al Mansurah', 'state': 'Aldakahlia', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ahmed M Elshal, MD', 'role': 'CONTACT', 'email': 'elshalam@hotmail.com', 'phone': '00201001855490'}, {'name': 'Ahmed M Elshal, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ahmed M Elasmy, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ahmed R El-Nahas, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Urology and Nephrology Center', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'centralContacts': [{'name': 'Ahmed m Elshal, MD', 'role': 'CONTACT', 'email': 'ELSHALAM@GMAIL.COM', 'phone': '+20502262222', 'phoneExt': '1428'}], 'overallOfficials': [{'name': 'Ahmed m Elshal, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mansoura University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Ahmed Elshal', 'investigatorAffiliation': 'Mansoura University'}}}}