Nephrolithiasis (Kidney Stones). Calculus of kidney and ureter
Conditions
Interventions
Intervention 1: Intervention group: All nephrolithotomy instruments used in percutaneous nephrolithotomy (PCNL), including dilators, nephroscope, and lithotripsy probe, are immersed in a solution of e
Sponsors
Ahvaz University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Patients with large kidney stones (>2 cm) eligible for percutaneous nephrolithotomy (PCNL) Age 18 years or older No history of severe cardiovascular disease Informed consent obtained
Exclusion criteria
Exclusion criteria: Patients with active infection or sepsis History of allergy to epinephrine Pregnancy or breastfeeding Uncontrolled hypertension or cardiac arrhythmia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intraoperative blood loss calculated by comparing hematocrit values of irrigation fluid and patient blood during PCNL. Timepoint: Measured intraoperatively at the end of the lithotripsy phase and before completion of the procedure. Method of measurement: Hematocrit of irrigation fluid and patient blood will be measured, and blood loss volume will be calculated using the standard formula for intraoperative bleeding estimation.;Surgical field visibility during PCNL procedure. Timepoint: Assessed intraoperatively and recorded by the main surgeon at the end of the procedure. Method of measurement: Evaluated using a five-point Likert scale (1 = very poor, 5 = excellent), scored by the main surgeon.;Change in patient hemoglobin level before surgery and 24 hours after PCNL. Timepoint: Blood samples collected at two time points: before surgery and 24 hours postoperatively. Method of measurement: Hemoglobin concentration will be measured using the hospital’s standard laboratory method.;Change in patient hematocrit level before surgery and 24 hours after PCNL. Timepoint: Measured before surgery and 24 hours postoperatively. Method of measurement: Hematocrit will be measured by the standard centrifugation method in the hospital laboratory.;Hemostatic performance index as a composite score including blood loss volume, hemoglobin change, and surgical field visibility to assess the efficacy of epinephrine in intraoperative bleeding control. Timepoint: Assessed at the end of the surgery after recording final data on blood loss, hemoglobin change, and surgical field visibility. Method of measurement: Calculated as a standardized Z-score composite index of the three main parameters (blood loss, ?Hb, and field visibility). | — |
Secondary
| Measure | Time frame |
|---|---|
| Stone-Free Rate (SFR) at 4-week postoperative follow-up assessed by CT scan. Timepoint: 4 weeks after surgery. Method of measurement: Radiological assessment by an independent radiologist to determine the presence of residual stones = 4 mm.;Surgery duration (from initial incision to completion of procedure). Timepoint: Intraoperatively, from skin incision to completion of surgery. Method of measurement: Recorded by the surgical assistant or designated nurse using a stopwatch.;Postoperative pain assessed using the Visual Analog Scale (VAS). Timepoint: 1, 6, 12, and 24 hours postoperatively. Method of measurement: Patients rate their pain on a scale of 0 (no pain) to 10 (worst possible pain).;Postoperative complications (e.g., infection, bleeding, reaction to epinephrine) graded by Clavien–Dindo classification. Timepoint: During hospital stay and up to 4 weeks postoperatively. Method of measurement: Complications recorded and classified by the surgeon and nursing team according to Clavien–Dindo grading system.;Requirement for blood transfusion within 24 hours after PCNL (Yes/No). Timepoint: Within 24 hours postoperatively. Method of measurement: Recorded by nursing and surgical team according to hospital protocol. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactArash Karimi baba ahmadi
Ahvaz University of Medical Sciences
Outcome results
None listed