Actively Recruiting
The Effect of Surgical Position on Hemodynamics in Percutaneous Nephrolithotomy Performed in Prone and Supine Positions
Led by Gaziosmanpasa Research and Education Hospital · Updated on 2025-08-24
84
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects of surgical positioning on hemodynamic stability during percutaneous nephrolithotomy (PNL), a minimally invasive procedure to remove large kidney stones. This randomized controlled trial compares prone and supine positions to see how each impacts blood pressure, heart rate, and other cardiovascular measures during and after surgery. The goal is to provide evidence that helps guide the choice of surgical position, especially for patients who may have risks related to blood flow and heart function. The study involves 84 patients aged 18 to 80 years who are scheduled for elective PNL and have physical health status classified as ASA I-III. Participants are randomly assigned to one of two groups: one undergoing PNL in the prone position and the other in the Galdakao-modified Valdivia supine position. Both procedures include ureteral catheter placement, renal access using fluoroscopy, and stone fragmentation using pneumatic or ultrasonic lithotripters. The surgical techniques and postoperative care protocols are standardized across both groups. During the study, researchers will monitor various hemodynamic parameters such as blood pressure, heart rate, arterial blood gases, and oxygen levels from anesthesia induction through surgery and into the first postoperative day. They will also collect data on surgery duration, anesthesia time, blood loss, complications, residual stones detected by CT scan one month after surgery, nephrostomy tube duration, and length of hospital stay. These measurements will help assess the safety and cardiovascular effects of each surgical position throughout the perioperative period.
CONDITIONS
Brief Title
Hemodynamic Effects of Surgical Position in Prone vs. Supine Percutaneous Nephrolithotomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- ASA physical status I-III
- Presence of renal calculi indicated for PNL
- Age between 18 and 80 years
- Scheduled for elective percutaneous nephrolithotomy
You will not qualify if you...
- Pregnancy
- Uncontrolled coagulopathy
- Previous renal surgery
- Severe cardiac, pulmonary, or neurological disease
- Preoperative urinary tract infection (non-sterile urine culture)
- Surgery duration less than 60 minutes or more than 120 minutes
- Preoperative blood transfusion
- Multiple access tracts
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 60 to 120 minutes for surgery; anesthesia duration 60 to 240 minutes
Participants undergo percutaneous nephrolithotomy (PNL) in either the prone or supine surgical position. The procedure includes anesthesia, ureteral catheter placement, renal access under fluoroscopic guidance, stone fragmentation, and nephrostomy tube placement according to standardized protocols.
1 surgical visit (in-person)
Duration - Up to 30 days postoperatively, with nephrostomy tube removal typically within 7 to 14 days and hospital stay lasting 2 to 10 days
Participants are monitored postoperatively for nephrostomy tube duration, length of hospital stay, and complications. Residual stones will be assessed by CT scan approximately 1 month after surgery.
Approximately 6 post-operative visits including hospital stay and follow-up CT scan
Trial Site Locations
Total: 1 location
1
Gaziosmanpaşa Training and Research Hospital
Istanbul, Turkey (Türkiye), 34275
Actively Recruiting
Research Team
A
ARİF BURAK KEÇEBAŞ, UROLOGY CLINIC DOCTOR
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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