Percutaneous nephrolithotomy is a minimally invasive surgical procedure used to remove large kidney stones. Although it is an effective treatment, bleeding during and after the procedure remains one of the main concerns and may sometimes require blood transfusion. Tranexamic acid is a medication that helps reduce bleeding by limiting the breakdown of blood clots. It can be given through a vein and may also be used locally in irrigation fluid during surgery. This study evaluates whether using tranexamic acid by both routes during percutaneous nephrolithotomy can reduce blood loss, improve the clarity of the surgical field during endoscopy, and reduce the need for blood transfusion. The study included adult patients with kidney stones larger than two centimeters who were suitable for percutaneous nephrolithotomy. Patients were randomly assigned to receive either tranexamic acid through a vein and in the irrigation fluid, or normal saline as a control treatment. Blood loss was assessed using hemoglobin and hematocrit levels before and after surgery, as well as hemoglobin concentration in the irrigation fluid collected at the end of the operation. The surgeon also assessed the clarity of the surgical field using a ten-point visual scale. The hypothesis of the study is that combined intravenous and local administration of tranexamic acid in irrigation fluid during percutaneous nephrolithotomy reduces blood loss, improves surgical visibility, and lowers the need for blood transfusion compared with normal saline.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
90
Tranexamic acid was administered as a combined intravenous and local intervention during percutaneous nephrolithotomy. The intravenous dose was given before anesthesia induction, and the local dose was added to the initial irrigation fluid used during the procedure.
Normal saline was used as the placebo comparator. It was administered intravenously before anesthesia induction and added to the initial irrigation fluid during percutaneous nephrolithotomy.
Benha University Hospital
Banhā, Qalyubia Governorate, Egypt
Change in hemoglobin concentration after percutaneous nephrolithotomy
Difference in hemoglobin concentration measured before surgery and after surgery to assess perioperative blood loss.
Time frame: Preoperative, immediate postoperative, and 24 hours postoperative
Change in hematocrit concentration after percutaneous nephrolithotomy
Difference in hematocrit concentration measured before surgery and after surgery as an additional indicator of perioperative blood loss.
Time frame: Preoperative, immediate postoperative, and 24 hours postoperative
Need for blood transfusion
Number of participants who required blood transfusion during the intraoperative or postoperative hospital stay period.
Time frame: Intraoperatively and up to 24 hours postoperatively
Hemoglobin concentration in irrigation fluid
Hemoglobin concentration measured in the irrigation fluid collected at the end of surgery as an estimate of intraoperative blood loss.
Time frame: At the end of surgery
Endoscopic surgical field visibility score
Surgical field visibility was assessed by the operating surgeon using a 10-point visual scale. The score ranges from 1 to 10, where 1 indicates very poor visibility and 10 indicates perfect visibility. Higher scores indicate better endoscopic surgical field visibility.
Time frame: At the end of surgery
Postoperative Hematuria
Number of participants who developed visible blood-stained urine after percutaneous nephrolithotomy.
Time frame: Up to 24 hours postoperatively
Need for Additional Hemostatic Intervention
Number of participants who required an additional intervention to control bleeding after percutaneous nephrolithotomy.
Time frame: Up to 24 hours postoperatively
Postoperative Infection
Number of participants who developed postoperative infection after percutaneous nephrolithotomy.
Time frame: Up to 24 hours postoperatively
Postoperative Hematuria
Number of participants with visible hematuria requiring continued nephrostomy tube closure or delayed nephrostomy tube removal.
Time frame: Up to 24 hours postoperatively
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