NCT02293759

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 13, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 18, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

March 29, 2016

Status Verified

March 1, 2016

Enrollment Period

1.8 years

First QC Date

November 13, 2014

Last Update Submit

March 27, 2016

Conditions

Benign Prostatic Hyperplasia

Keywords

BPH- LASER- PROSTATE- BLEEDING TENDENCY

Outcome Measures

Primary Outcomes (1)

  • perioperative blood loss

    48 hours

Secondary Outcomes (3)

  • readmission

    30 days

  • blood transfusion

    30 days

  • flow rate

    3 months

Study Arms (2)

HoLEP

ACTIVE COMPARATOR

Holmium laser enucleation of the prostate

Procedure: HoLEP

Greenlight laser PVP

ACTIVE COMPARATOR

Phtoselective vaporization of the prostate

Procedure: Greenlight laser PVP

Interventions

HoLEPPROCEDURE

Holmium laser enucleation of the prsotate

HoLEP
Greenlight laser PVPPROCEDURE

Greenlight laser (532nm) Photoslective vaporization of the prostate

Greenlight laser PVP

Eligibility Criteria

Age50 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Correctable bleeding tendency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urology and Nephrology Center

Al Mansurah, Aldakahlia, 35516, Egypt

RECRUITING

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Ahmed m Elshal, MD

    Mansoura University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed m Elshal, MD

CONTACT

+20502262222ELSHALAM@GMAIL.COM

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

November 13, 2014

First Posted

November 18, 2014

Study Start

October 1, 2014

Primary Completion

August 1, 2016

Study Completion

September 1, 2016

Last Updated

March 29, 2016

Record last verified: 2016-03

Locations

EG(1)