Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2025-12-25 @ 11:56 PM
Study NCT ID:
NCT02293759
Status:
UNKNOWN
Last Update Posted:
2016-03-29
First Post:
2014-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial of HoLEP vs. PVP in Treating BPH in Patients With Bleeding Tendency
Sponsor:
Mansoura University
Organization:
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2016-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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;
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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: