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Trial of HoLEP vs. PVP in Treating BPH in Patients With Bleeding Tendency

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ClinicalTrials.gov Identifier: NCT02293759
Recruitment Status : Unknown
Verified March 2016 by Ahmed Elshal, Mansoura University.
Recruitment status was:  Recruiting
First Posted : November 18, 2014
Last Update Posted : March 29, 2016
Sponsor:
Information provided by (Responsible Party):
Ahmed Elshal, Mansoura University

Brief Summary:

Patients presented for BPH surgery at our out patient clinic will be assessed for abnormal bleeding profile.

Patients 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


Condition or disease Intervention/treatment Phase
Benign Prostatic Hyperplasia Procedure: HoLEP Procedure: Greenlight laser PVP Phase 4

Detailed Description:

Elderly patients with bleeding tendency either secondary;

  1. Strict antiplatelet intake
  2. Strict anticoagulant intake
  3. uncorrected natural bleeding tendency e.g; patients with liver cell failure are at higher risk of perioperative bleeding when subjected to prostate surgery.

Laser 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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2014
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: HoLEP
Holmium laser enucleation of the prostate
Procedure: HoLEP
Holmium laser enucleation of the prsotate

Active Comparator: Greenlight laser PVP
Phtoselective vaporization of the prostate
Procedure: Greenlight laser PVP
Greenlight laser (532nm) Photoslective vaporization of the prostate




Primary Outcome Measures :
  1. perioperative blood loss [ Time Frame: 48 hours ]

Secondary Outcome Measures :
  1. readmission [ Time Frame: 30 days ]
  2. blood transfusion [ Time Frame: 30 days ]
  3. flow rate [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02293759


Contacts
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Contact: Ahmed m Elshal, MD +20502262222 ext 1428 ELSHALAM@GMAIL.COM

Locations
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Egypt
Urology and Nephrology Center Recruiting
Mansoura, Aldakahlia, Egypt, 35516
Contact: Ahmed M Elshal, MD    00201001855490    elshalam@hotmail.com   
Principal Investigator: Ahmed M Elshal, MD         
Sub-Investigator: Ahmed M Elasmy, MD         
Sub-Investigator: Ahmed R El-Nahas, MD         
Sponsors and Collaborators
Mansoura University
Investigators
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Principal Investigator: Ahmed m Elshal, MD Mansoura University

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Responsible Party: Ahmed Elshal, Dr, Mansoura University
ClinicalTrials.gov Identifier: NCT02293759     History of Changes
Other Study ID Numbers: Mans-2014-04
First Posted: November 18, 2014    Key Record Dates
Last Update Posted: March 29, 2016
Last Verified: March 2016
Keywords provided by Ahmed Elshal, Mansoura University:
BPH- LASER- PROSTATE- BLEEDING TENDENCY
Additional relevant MeSH terms:
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Prostatic Hyperplasia
Hemostatic Disorders
Blood Coagulation Disorders
Hemorrhage
Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders