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

March 27, 2016 updated by: Ahmed Elshal, Mansoura University

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Aldakahlia
      • Mansoura, Aldakahlia, Egypt, 35516
        • Recruiting
        • Urology and nephrology center
        • Principal Investigator:
          • Ahmed M Elshal, MD
        • Sub-Investigator:
          • Ahmed M Elasmy, MD
        • Sub-Investigator:
          • Ahmed R El-Nahas, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
perioperative blood loss
Time Frame: 48 hours
48 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
readmission
Time Frame: 30 days
30 days
blood transfusion
Time Frame: 30 days
30 days
flow rate
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (ANTICIPATED)

August 1, 2016

Study Completion (ANTICIPATED)

September 1, 2016

Study Registration Dates

First Submitted

November 13, 2014

First Submitted That Met QC Criteria

November 17, 2014

First Posted (ESTIMATE)

November 18, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

March 29, 2016

Last Update Submitted That Met QC Criteria

March 27, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mans-2014-04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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