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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05913466
Other study ID # Rc 5-5-2022
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 20, 2023
Est. completion date June 20, 2024

Study information

Verified date June 2023
Source Benha University
Contact Tamer Diab, MD
Phone 01003583264
Email tamer.diab@fmed.bu.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date June 20, 2024
Est. primary completion date June 20, 2024
Accepts healthy volunteers No
Gender Male
Age group 50 Years to 85 Years
Eligibility 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 5a-reductase inhibitors.

Study Design


Intervention

Drug:
Tranexamic Acid group
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
This group will receive 10 mL of distilled water (placebo) in 1 L of irrigation solution sterile wash (glycine).

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Benha University

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary Postoperative hospital stay length Postoperative hospital stay length will be assessed in days 2 weeks Postoperatively
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