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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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11 April 2016 |
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Main ID: |
NCT02293759 |
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Date of registration:
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13/11/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Trial of HoLEP vs. PVP in Treating BPH in Patients With Bleeding Tendency
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Scientific title:
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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 |
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Date of first enrolment:
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October 2014 |
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Target sample size:
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60 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02293759 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Egypt
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Contacts
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Name:
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Ahmed m Elshal, MD |
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Address:
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Telephone:
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+20502262222 |
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Email:
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ELSHALAM@GMAIL.COM |
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Affiliation:
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Name:
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Ahmed M Elshal, MD |
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Address:
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Telephone:
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00201001855490 |
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Email:
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elshalam@hotmail.com |
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Affiliation:
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Name:
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Ahmed m Elshal, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Mansoura Urology and Nephrology center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- BPH patients candidate for transurethral prostate surgery after failure of medical
treatment
- Perioperative uncorrected Blleding tendency
1. patients with naturally induced uncorrectable bleeding tendency;
1. platelet count less than 100000/mm3
2. INR more than 1.5
2. Patients on oral antiplatlet that deemed unsafe to stop prior to surgery as per
intenist
3. Patients on oral anticoagulant that deemed unsafe to stop prior to surgery as
per intenist
Exclusion Criteria:
- Correctable bleeding tendency
Age minimum:
50 Years
Age maximum:
N/A
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Benign Prostatic Hyperplasia
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Intervention(s)
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Procedure: HoLEP
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Procedure: Greenlight laser PVP
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Primary Outcome(s)
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perioperative blood loss
[Time Frame: 48 hours]
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Secondary Outcome(s)
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readmission
[Time Frame: 30 days]
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flow rate
[Time Frame: 3 months]
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blood transfusion
[Time Frame: 30 days]
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Secondary ID(s)
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Mans-2014-04
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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