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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tranexamic Acid group | Experimental | Patients in this group will receive 1 gm of Tranexamic Acid (Cyklokapron) that will be dissolved in 50 ml of injectable 0.9% saline |
|
| Distilled water group | Placebo Comparator | This group will receive 10 mL of distilled water (placebo) in 1 L of irrigation solution sterile wash (glycine). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid group | Drug | Patients in this group will receive 1 gm of Tranexamic Acid (Cyklokapron) that will be dissolved in 50 ml of injectable 0.9% saline |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion 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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tamer Diab, MD | Contact | 01003583264 | +2 | tamer.diab@fmed.bu.edu.eg |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38788904 | Derived | Diab T, El Hamshary SA, Abou Elezz A, El-Dakhakhny AS. Intraprostatic Injection of Tranexamic Acid Decrease Blood Loss During Monopolar Transurethral Resection of the Prostate: A Randomized Controlled Clinical Trial. Urology. 2024 Sep;191:119-126. doi: 10.1016/j.urology.2024.05.015. Epub 2024 May 22. |
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The study protocol will be available under a clear request for the primary investigator
One year after the end of the trial
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| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| Distilled water group | Drug | This group will receive 10 mL of distilled water (placebo) in 1 L of irrigation solution sterile wash (glycine). |
|
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 |
| D052801 |
| Male Urogenital Diseases |