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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2016-09-30

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

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Detailed Description

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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

Conditions

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Benign Prostatic Hyperplasia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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HoLEP

Holmium laser enucleation of the prostate

Group Type ACTIVE_COMPARATOR

HoLEP

Intervention Type PROCEDURE

Holmium laser enucleation of the prsotate

Greenlight laser PVP

Phtoselective vaporization of the prostate

Group Type ACTIVE_COMPARATOR

Greenlight laser PVP

Intervention Type PROCEDURE

Greenlight laser (532nm) Photoslective vaporization of the prostate

Interventions

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HoLEP

Holmium laser enucleation of the prsotate

Intervention Type PROCEDURE

Greenlight laser PVP

Greenlight laser (532nm) Photoslective vaporization of the prostate

Intervention Type PROCEDURE

Eligibility 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