Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID07138872

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

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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)

Post-operative Follow-up

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

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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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