Intraprostatic Injection of Tranexamic Acid Decrease Blood Loss During Monopolar TURP

Study Overview
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Brief Summary
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This study aims to assess the role of intraprostatic injection of tranexamic acid in decreasing the blood loss during Transurethral resection of the prostate.

Detailed Description
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Benign prostatic hyperplasia (BPH) is a process in which the pathology results in increased number of both stromal and epithelial cells in the area of the prostate around the urethra, which is pathologically known as hyperplasia, and not hypertrophy. The accurate cause is not well known; however, reactivation of embryonic processes is one of the hypotheses that may cause benign prostatic hyperplasia (BPH). Benign prostatic hyperplasia (BPH) is a common condition that affects elderly men. Recently, many noninvasive and mini-invasive modalities have become popular for the management of men with voiding symptoms. Transurethral resection of the prostate (TURP) is one of the most common and well-developed techniques used to treat benign prostatic hyperplasia (BPH), recognized as the 'gold standard' of the surgical treatments of enlarged prostates. The most relevant complications are the inability to void (5.8%), surgical revision (5.6%), urinary tract infection (UTI) (3.6%), bleeding requiring transfusions (2.9%), and Transurethral resection syndrome (1.4%). As the prostate has a rich blood supply, bleeding is one of the most common complications of Transurethral resection of the prostate.

Official Title
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Intraprostatic Injection of Tranexamic Acid Decrease Blood Loss During Monopolar TURP

Conditions
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Benign Prostatic Hyperplasia, Transurethral Resection of the Prostate, Tranexamic Acid

Intervention / Treatment
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* Drug: Tranexamic Acid group
* Drug: Distilled water group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with an age between 50 and 85 years old who had benign prostatic hyperplasia (aged 50-85 years) with a prostate weight of 50-80 g. undergoing Transurethral resection of the prostate Exclusion Criteria: Patient refusal. Patients hypersensitive to Tranexamic Acid, or on antiplatelet and anticoagulant drugs. Patients with a history of thrombotic events, bleeding disorders, chronic kidney disease. Patients with abnormal liver function test. Patients with cardiovascular disease and receiving with a drug-eluting stent, bladder stone, urethral stricture, or with previous prostate surgery, prostate cancer, with a UTI or who receiving 5α-reductase inhibitors.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tranexamic Acid group<br>Patients in this group will receive 1 gm of Tranexamic Acid (Cyklokapron) that will be dissolved in 50 ml of injectable 0.9% saline | Drug: Tranexamic Acid group<br>* Patients in this group will receive 1 gm of Tranexamic Acid (Cyklokapron) that will be dissolved in 50 ml of injectable 0.9% saline<br>|
| Placebo Comparator: Distilled water group<br>This group will receive 10 mL of distilled water (placebo) in 1 L of irrigation solution sterile wash (glycine). | Drug: Distilled water group<br>* This group will receive 10 mL of distilled water (placebo) in 1 L of irrigation solution sterile wash (glycine).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of Blood Loss During Monopolar transurethral resection of the prostate | The efficacy of intraprostatic injection of tranexamic acid in reducing intraoperative bleeding will be assessed in litter. | 2 weeks Postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin (Hb) level | This outcome evaluates the changes in hemoglobin (Hb) level before and after the monopolar transurethral resection of the prostate (TURP) procedure. | 2 weeks Postoperatively | 
| Hematocrit (HCT) Level | This outcome evaluates the changes in hematocrit (HCT) level before and after the monopolar transurethral resection of the prostate (TURP) procedure. | 2 weeks Postoperatively | 
| Postoperative hospital stay length | Postoperative hospital stay length will be assessed in days | 2 weeks Postoperatively |