Kidney Stones, Percutaneous Nephrolithotomy, Surgical Blood Loss
Conditions
Keywords
Kidney stones, Irrigation fluid, Blood loss, Blood transfusion, Tranexamic acid, Percutaneous nephrolithotomy, Renal stones, Surgical field visibility, Endoscopic visual clarity, Urologic surgery
Brief summary
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.
Interventions
DRUGTranexamic acid
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.
DRUGNormal Saline
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.
Sponsors
Benha University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The study was double-blinded. Participants, care providers, investigators, and outcome assessors were masked to group allocation. Tranexamic acid and placebo were prepared in a similar manner, with normal saline used as placebo in the control group.
Intervention model description
Participants were randomly assigned to one of two parallel groups. The intervention group received tranexamic acid intravenously before anesthesia induction and locally in the irrigation fluid during percutaneous nephrolithotomy. The control group received normal saline intravenously and in the irrigation fluid.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Adult patients aged 18 to 70 years. * Patients with renal stones larger than 2 centimeters. * Patients scheduled for percutaneous nephrolithotomy. * Normal renal function, defined as serum creatinine less than or equal to 1.5 milligrams per deciliter. * American Society of Anesthesiologists physical status class 1 or 2.
Exclusion criteria
* Hypersensitivity to tranexamic acid. * Pregnancy. * Current anticoagulation therapy. * Untreated urinary tract infection or urosepsis. * Renal anatomical anomalies, including ectopic kidney, duplex collecting system, or horseshoe kidney. * Solitary functioning kidney. * Decompensated coagulopathy or known hematological disease. * Acute or chronic renal disease. * History of cerebrovascular events or thromboembolism. * Uncontrolled arrhythmia. * Morbid obesity.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in hemoglobin concentration after percutaneous nephrolithotomy | Preoperative, immediate postoperative, and 24 hours postoperative | Difference in hemoglobin concentration measured before surgery and after surgery to assess perioperative blood loss. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in hematocrit concentration after percutaneous nephrolithotomy | Preoperative, immediate postoperative, and 24 hours postoperative | Difference in hematocrit concentration measured before surgery and after surgery as an additional indicator of perioperative blood loss. |
| Need for blood transfusion | Intraoperatively and up to 24 hours postoperatively | Number of participants who required blood transfusion during the intraoperative or postoperative hospital stay period. |
| Hemoglobin concentration in irrigation fluid | At the end of surgery | Hemoglobin concentration measured in the irrigation fluid collected at the end of surgery as an estimate of intraoperative blood loss. |
| Endoscopic surgical field visibility score | At the end of surgery | 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. |
| Postoperative Hematuria | Up to 24 hours postoperatively | Number of participants who developed visible blood-stained urine after percutaneous nephrolithotomy. |
| Need for Additional Hemostatic Intervention | Up to 24 hours postoperatively | Number of participants who required an additional intervention to control bleeding after percutaneous nephrolithotomy. |
| Postoperative Infection | Up to 24 hours postoperatively | Number of participants who developed postoperative infection after percutaneous nephrolithotomy. |
Countries
Egypt
Outcome results
None listed