Clinical trial NCT05913466: Intraprostatic Injection of Tranexamic Acid Decrease Blood Loss During Monopolar TURP
Official title: Intraprostatic Injection of Tranexamic Acid Decrease Blood Loss During Monopolar TURP
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Benign Prostatic Hyperplasia
Transurethral Resection of the Prostate
Tranexamic Acid
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2023-06-22
Enrollment: 60
Sex: MALE
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Amount of Blood Loss During Monopolar transurethral resection of the prostate
timeFrame: 2 weeks Postoperatively
Secondary outcomes:
measure: Hemoglobin (Hb) level
timeFrame: 2 weeks Postoperatively
measure: Hematocrit (HCT) Level
timeFrame: 2 weeks Postoperatively
measure: Postoperative hospital stay length
timeFrame: 2 weeks Postoperatively
Other outcomes:
Locations:
Study officials:
References: