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Clinical Trials/NCT05784181
NCT05784181
Recruiting
Not Applicable

Bipolar Versus Laser Enaculation of Prostate for >80gram Prostate .

Menoufia University1 site in 1 country40 target enrollmentOctober 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Bipolar TURP , Laser Enucleation in Management of Enlarged Prostate
Sponsor
Menoufia University
Enrollment
40
Locations
1
Primary Endpoint
compare the efficacy of Bipolar versus Laser enaculation of prostate for >80gram.
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

Transurethral resection of the prostate (TURP ) still the gold standerad for surgical management of enlarged prostate .However , many minimally invasive procedures are now in the comparative track with Bipolar resection as Laser enaculation.

Holmium laser prostatectomy was introduced since 1994 . different types of uses by laser were introduced either resection or enaculation with good outcomes and less complications .

One of the most important issues related to large prostate management is the retreatment after Bipolar resection , another issue that prolonged catheter time post resection .

Detailed Description

Transurethral resection of the prostate (TURP ) still the gold standerad for surgical management of enlarged prostate .However , many minimally invasive procedures are now in the comparative track with Bipolar resection as Laser enaculation. Holmium laser prostatectomy was introduced since 1994 . different types of uses by laser were introduced either resection or enaculation with good outcomes and less complications . One of the most important issues related to large prostate management is the retreatment after Bipolar resection , another issue that prolonged catheter time post resection , so , we try to analyze the effect of Laser enaculation of the prostate in comparison to Bipolar resection in prostate more than 80 gm . Aim of the work: Aim of the work is to compare the efficacy of Bipolar versus Laser enaculation of prostate for \>80gram. Patients and Methods: A randomized comparative study will be conducted at Menoufia university hospital , urology department. patients will be selected after informed consent. Inclusion criteria: similar for all patients prostatic volume more than 80 gm , peak urinary flow rate measurement (Qmax) \<15 ml/s, International Prostate Symptom Score (IPSS) of \>8 , postvoid residual (PVR) \<400 ml. Exclusion criteria: Patients with prostate size less than 80gm , urethral stricture, acute urinary tract infection, repeated treatment . Preoperatively, all the patients will undergo thorough process of history taking , clinical examination, and investigations in the form of abdominopelvic and trans rectal ultrasonography , PSA ,urine analysis, urine culture if needed and routine pre-operative lab investigations as (CBC , PT, LFTs, serum creatinine and RBS). The treatment modality chosen for an individual will be randomized . All patients with positive urine culture will be treated by proper antibiotics before the procedures. Peri-operatively , all patients will receive a single shot of pre-operative antibiotic. For the first group patients transurethral resection of prostate For the second group patients Laser enaculation by holmium: YAG laser Postoperatively, patients will undergo IPSS score , flowmetry post operative after 3months .

Registry
clinicaltrials.gov
Start Date
October 1, 2021
End Date
December 1, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hossam Kandeel

Yassin Abdel Ghaffar St- from Gamal Abdel Anasar St - Faculty of Medicine.

Menoufia University

Eligibility Criteria

Inclusion Criteria

  • similar for all patients prostatic volume more than 80 gm , peak urinary flow rate measurement (Qmax) \<15 ml/s, International Prostate Symptom Score (IPSS) of \>8 , postvoid residual (PVR) \<400 ml

Exclusion Criteria

  • Patients with prostate size less than 80gm , urethral stricture, acute urinary tract infection, repeated treatment .

Outcomes

Primary Outcomes

compare the efficacy of Bipolar versus Laser enaculation of prostate for >80gram.

Time Frame: 1 year

compare the efficacy of Bipolar versus Laser enaculation of prostate for \>80gram.

Study Sites (1)

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