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UnknownNCT05913466

Intraprostatic Injection of Tranexamic Acid Decrease Blood Loss During Monopolar TURP

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
60 (estimated)
Sponsor
Benha University · Academic / Other
Sex
Male
Age
50 Years – 85 Years
Healthy volunteers
Not accepted

Summary

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

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.

Conditions

Interventions

TypeNameDescription
DRUGTranexamic Acid groupPatients in this group will receive 1 gm of Tranexamic Acid (Cyklokapron) that will be dissolved in 50 ml of injectable 0.9% saline
DRUGDistilled water groupThis group will receive 10 mL of distilled water (placebo) in 1 L of irrigation solution sterile wash (glycine).

Timeline

Start date
2023-06-20
Primary completion
2024-06-20
Completion
2024-06-20
First posted
2023-06-22
Last updated
2023-06-22

Source: ClinicalTrials.gov record NCT05913466. Inclusion in this directory is not an endorsement.