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

Study Overview
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Brief Summary
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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
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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

Official 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

Conditions
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Benign Prostatic Hyperplasia

Intervention / Treatment
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* Procedure: HoLEP
* Procedure: Greenlight laser PVP


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: HoLEP<br>Holmium laser enucleation of the prostate | Procedure: HoLEP<br>* Holmium laser enucleation of the prsotate<br>|
| Active Comparator: Greenlight laser PVP<br>Phtoselective vaporization of the prostate | Procedure: Greenlight laser PVP<br>* Greenlight laser (532nm) Photoslective vaporization of the prostate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| perioperative blood loss |  | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| readmission |  | 30 days | 
| blood transfusion |  | 30 days | 
| flow rate |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BPH- LASER- PROSTATE- BLEEDING TENDENCY