Trial of HoLEP vs. PVP in Treating BPH in Patients With Bleeding Tendency
Primary Purpose
Benign Prostatic Hyperplasia
Status
Unknown status
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
HoLEP
Greenlight laser PVP
Sponsored by
About this trial
This is an interventional treatment trial for Benign Prostatic Hyperplasia focused on measuring BPH- LASER- PROSTATE- BLEEDING TENDENCY
Eligibility Criteria
Inclusion Criteria:
- BPH patients candidate for transurethral prostate surgery after failure of medical treatment
Perioperative uncorrected Blleding tendency
patients with naturally induced uncorrectable bleeding tendency;
- platelet count less than 100000/mm3
- INR more than 1.5
- Patients on oral antiplatlet that deemed unsafe to stop prior to surgery as per intenist
- Patients on oral anticoagulant that deemed unsafe to stop prior to surgery as per intenist
Exclusion Criteria:
- Correctable bleeding tendency
Sites / Locations
- Urology and Nephrology CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
HoLEP
Greenlight laser PVP
Arm Description
Holmium laser enucleation of the prostate
Phtoselective vaporization of the prostate
Outcomes
Primary Outcome Measures
perioperative blood loss
Secondary Outcome Measures
readmission
blood transfusion
flow rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02293759
Brief Title
Trial of HoLEP vs. PVP in Treating BPH in Patients With Bleeding Tendency
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 Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
August 2016 (Anticipated)
Study Completion Date
September 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
Detailed Description
Elderly patients with bleeding tendency either secondary;
Strict antiplatelet intake
Strict anticoagulant intake
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia
Keywords
BPH- LASER- PROSTATE- BLEEDING TENDENCY
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HoLEP
Arm Type
Active Comparator
Arm Description
Holmium laser enucleation of the prostate
Arm Title
Greenlight laser PVP
Arm Type
Active Comparator
Arm Description
Phtoselective vaporization of the prostate
Intervention Type
Procedure
Intervention Name(s)
HoLEP
Intervention Description
Holmium laser enucleation of the prsotate
Intervention Type
Procedure
Intervention Name(s)
Greenlight laser PVP
Intervention Description
Greenlight laser (532nm) Photoslective vaporization of the prostate
Primary Outcome Measure Information:
Title
perioperative blood loss
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
readmission
Time Frame
30 days
Title
blood transfusion
Time Frame
30 days
Title
flow rate
Time Frame
3 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
BPH patients candidate for transurethral prostate surgery after failure of medical treatment
Perioperative uncorrected Blleding tendency
patients with naturally induced uncorrectable bleeding tendency;
platelet count less than 100000/mm3
INR more than 1.5
Patients on oral antiplatlet that deemed unsafe to stop prior to surgery as per intenist
Patients on oral anticoagulant that deemed unsafe to stop prior to surgery as per intenist
Exclusion Criteria:
Correctable bleeding tendency
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed m Elshal, MD
Phone
+20502262222
Ext
1428
Email
ELSHALAM@GMAIL.COM
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed m Elshal, MD
Organizational Affiliation
Mansoura University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Urology and Nephrology Center
City
Mansoura
State/Province
Aldakahlia
ZIP/Postal Code
35516
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed M Elshal, MD
Phone
00201001855490
Email
elshalam@hotmail.com
First Name & Middle Initial & Last Name & Degree
Ahmed M Elshal, MD
First Name & Middle Initial & Last Name & Degree
Ahmed M Elasmy, MD
First Name & Middle Initial & Last Name & Degree
Ahmed R El-Nahas, MD
12. IPD Sharing Statement
Learn more about this trial
Trial of HoLEP vs. PVP in Treating BPH in Patients With Bleeding Tendency
We'll reach out to this number within 24 hrs