Hemodynamic Effects of Surgical Position in Prone vs. Supine Percutaneous Nephrolithotomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-01

Study Completion Date

2025-12-30

Brief Summary

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This prospective, randomized controlled study evaluates the hemodynamic effects of prone and supine positions during percutaneous nephrolithotomy (PNL) for large kidney stones. Surgical position may influence intraoperative and postoperative hemodynamic stability. Prone positioning can increase intrathoracic pressure and reduce venous return, whereas supine positioning may provide greater hemodynamic stability. A total of 84 patients will be randomized to undergo PNL in prone or supine positions. Primary outcomes include changes in hemodynamic parameters during surgery. Results may guide surgical position selection, especially in patients with potential hemodynamic risk.

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Detailed Description

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Percutaneous nephrolithotomy (PNL) is a widely used minimally invasive surgical technique for the treatment of large and complex renal calculi. Traditionally, PNL has been performed in the prone position; however, the supine position has gained popularity in recent years due to potential anesthetic and surgical advantages. Surgical positioning can significantly influence cardiovascular and respiratory function, potentially leading to intraoperative and postoperative hemodynamic fluctuations.

Previous literature suggests that the prone position may increase intrathoracic pressure and impair venous return, potentially compromising hemodynamic stability, while the supine position may provide a more stable cardiovascular profile. However, existing data are limited, and results remain inconclusive, particularly in direct comparative studies.

This prospective, randomized controlled clinical trial aims to compare the effects of prone and supine positions during PNL on patients' intraoperative and postoperative hemodynamic parameters. The study will enroll 84 patients aged 18-80 years with American Society of Anesthesiologists (ASA) physical status I-III undergoing elective PNL. Patients will be randomly assigned to either the prone (n=42) or supine (n=42) position.

Inclusion criteria include patients with renal calculi suitable for PNL and meeting the study's eligibility requirements. Exclusion criteria include pregnancy, uncontrolled coagulopathy, previous renal surgery, severe cardiac, pulmonary, or neurological disease, preoperative urinary tract infection, surgery duration outside 60-120 minutes, and multiple access tracts.

Preoperative evaluation will include demographic data, stone characteristics, and relevant laboratory and imaging findings. Intraoperative data will include systolic and diastolic blood pressure, heart rate, arterial blood gas analysis, operative time, anesthesia duration, access details, irrigation volume, and any transfusion or complications. Postoperative parameters will include nephrostomy duration, length of hospital stay, and presence of residual stones as assessed by postoperative CT scan.

Surgical techniques will be standardized for both positions. Prone PNL will involve initial lithotomy positioning for ureteral catheter placement followed by prone positioning for renal access under fluoroscopic guidance. Supine PNL will be performed in the Galdakao-modified Valdivia position with similar access and fragmentation protocols.

The primary outcome is the difference in intraoperative and postoperative hemodynamic stability between positions. Secondary outcomes include complication rates, residual stone rates, and hospital stay duration.

This study aims to provide high-quality evidence to guide surgeons and anesthesiologists in selecting the optimal patient position for PNL, particularly in individuals with higher hemodynamic risk.

Conditions

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Percutaneous Nephrolithotomy (PCNL) Surgical Positioning Prone Position Supine Position Hemodynamic Stability Nephrolithiasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Prone Position

Patients in this group will undergo percutaneous nephrolithotomy (PNL) in the prone position. The procedure begins with ureteral catheter placement in lithotomy position, followed by prone positioning for renal access under C-arm fluoroscopic guidance. Stone fragmentation will be performed using pneumatic or ultrasonic lithotripters, and nephrostomy placement will be completed according to standard protocol.

Group Type EXPERIMENTAL

Prone Position Percutaneous Nephrolithotomy

Intervention Type PROCEDURE

Patients in this arm will undergo percutaneous nephrolithotomy (PNL) in the prone position. The procedure begins with ureteral catheter placement in lithotomy position, followed by prone positioning for renal access under C-arm fluoroscopic guidance. Stone fragmentation will be performed using pneumatic or ultrasonic lithotripters, and nephrostomy placement will be completed according to standard protocol.

Supine Position

Patients in this group will undergo percutaneous nephrolithotomy (PNL) in the Galdakao-modified Valdivia supine position. Following general anesthesia, the ipsilateral side will be elevated 20-30°, with the ipsilateral leg extended and the contralateral leg abducted. Ureteral catheter placement will be followed by renal access under C-arm fluoroscopy. Stone fragmentation and removal will be performed using the same standardized lithotripsy and irrigation protocols as in the prone group.

Group Type EXPERIMENTAL

Supine Position Percutaneous Nephrolithotomy (Galdakao-modified Valdivia)

Intervention Type PROCEDURE

Patients in this arm will undergo percutaneous nephrolithotomy (PNL) in the Galdakao-modified Valdivia supine position. Following general anesthesia, the ipsilateral side will be elevated 20-30°, with the ipsilateral leg extended and the contralateral leg abducted. Ureteral catheter placement will be followed by renal access under C-arm fluoroscopy. Stone fragmentation and removal will be performed using the same standardized lithotripsy and irrigation protocols as in the prone group.

Interventions

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Prone Position Percutaneous Nephrolithotomy

Patients in this arm will undergo percutaneous nephrolithotomy (PNL) in the prone position. The procedure begins with ureteral catheter placement in lithotomy position, followed by prone positioning for renal access under C-arm fluoroscopic guidance. Stone fragmentation will be performed using pneumatic or ultrasonic lithotripters, and nephrostomy placement will be completed according to standard protocol.

Intervention Type PROCEDURE

Supine Position Percutaneous Nephrolithotomy (Galdakao-modified Valdivia)

Patients in this arm will undergo percutaneous nephrolithotomy (PNL) in the Galdakao-modified Valdivia supine position. Following general anesthesia, the ipsilateral side will be elevated 20-30°, with the ipsilateral leg extended and the contralateral leg abducted. Ureteral catheter placement will be followed by renal access under C-arm fluoroscopy. Stone fragmentation and removal will be performed using the same standardized lithotripsy and irrigation protocols as in the prone group.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* ASA physical status I-III
* Presence of renal calculi indicated for PNL

Exclusion Criteria

* Pregnancy
* Uncontrolled coagulopathy
* Previous renal surgery
* Severe cardiac, pulmonary, or neurological disease
* Preoperative urinary tract infection (non-sterile urine culture)
* Surgery duration \<60 minutes or \>120 minutes
* Preoperative blood transfusion
* Multiple access tracts

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No