Intra-Prostatic Epinephrine Injection in Bipolar Transurethral Resection of Large Prostate: Exploring Its Role in Optimizing Surgical Outcomes

Phase 3RecruitingNCT07733167

Benha University80 enrolled

Overview

Intra-Prostatic Epinephrine injection in Bipolar Transurethral resection of large prostate: Exploring Its Role in Optimizing Surgical Outcomes

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Intra-Prostatic Epinephrine Injection in Bipolar Transurethral Resection of Large Prostate

Interventions

TURPDEVICE

Intra-Prostatic Epinephrine injection in Bipolar Transurethral resection of large prostate

EpinephrineDRUG

Intra-Prostatic epinephrine injection in Bipolar Transurethral resection of large prostate

Eligibility

Sex: MALEMin age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Indication for Prostate Surgery or Procedure - Patients undergoing transurethral resection of the prostate (TURP) * Prostate from 80 to 100 gm * Failed medical therapy Exclusion Criteria: * Uncontrolled Hypertension - Patients with significantly high blood pressure despite medication therapy. * Unstable angina, recent myocardial infarction, arrhythmias, or severe heart failure. * Significant Coagulopathy - Patients with bleeding disorders or on anticoagulants where excessive vasoconstriction may lead to tissue necrosis or inadequate perfusion * Hyperthyroidism, Pheochromocytoma or Endocrine Disorders - Patients with catecholamine-secreting tumors or other conditions that can lead to excessive sympathetic stimulation. * Treatment in the last 3 months with 5-alpha reductase inhibitors. * Genitourinary cancer, urinary tract lithiasis, and urological surgery within the last 3 months

Locations (1)

Ahmed Abdelraouf Saad

Banhā, Qalyubia Governorate, Egypt

RECRUITING

Outcomes

Primary Outcomes

Intraoperative blood loss , need of blood transfusion

assessment of Blood Loss (Irrigation Fluid Hb Concentration): Bladder irrigation will be maintained for 24 hours post operatively, with fluid collections made at three intervals: Immediately postsurgery (V1), 6 hours postoperation (V2), and 24 hours postoperation (V3). The total volume collected will be measured, and 5000U of heparin will be added to each irrigation fluid container to prevent coagulation. After thorough mixing, 5-mL samples will be extracted and analyzed using cyanide met hemoglobin spectrophotometry at 540 nm to determine the Hb concentration. Blood loss will be estimated using specific formulas: (1) Hb concentration in irrigation fluid (g/L) = absorbance of fluid × 367.7; (2) Bleeding volume (mL) = (Hb concentration in irrigation fluid (g/L) × rinse volume (mL)) / preoperative Hb concentration(g/L).

Time frame: 24h post operative

Secondary Outcomes

Prostate volume , post voiding residual urine

prostate volume \& post voiding residual urine will be measured by Transrectal ultrasound

Time frame: 3 months

Data from ClinicalTrials.gov

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