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Completed

NCT Number: NCT05855057

Effectiveness of US-Guided PCNL Different Positions in Renal Stones Treatment

The aim of this study is to compare the effectiveness of Ultrasound-Guided Percutaneous nephrolithotomyin different positions supine, prone positions and flank suspend supine position in renal stones treatment.

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Key information

Conditions

Percutaneous Nephrolithotomy Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Nephrolithiasis Renal Stones Ultrasound Therapy; Complications Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Benha University Hospitals

Banhā, Egypt

About this study

Percutaneous nephrolithotomy (PCNL) has become the choice of modality for the treatment of large and complicated renal calculi. Initially, percutaneous access to the kidney was only performed in the prone position, as described sixty years ago.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients who underwent Percutaneous nephrolithotomy
  • Patient's age from >18 - 70 years old.
  • Body mass index (30-40 kg/m2).
  • Both sex
  • Renal stones diameter ≥2 cm
  • Cardiac patients

Exclusion criteria

  • Patient refusal.
  • Pregnant women.
  • Patients with renal anomalies.
  • Transplanted kidney.
  • Uncorrected coagulopathy, or active infection.

Treatment and study plan

Flank suspended supine position percutaneous nephrolithotomy

Procedure

The patients will be placed in the supine position with the shoulder and the buttock will be raised by a 3-l bag of water suspending the flank of the affected side. The body contour will be aligned to the edge of the table. The operating table will be adjusted to the jack knife position, with the tip of the lower part of the table will be slightly lowered. The leg of the affected side of the patent will be straightened dorsally flexed and slightly inner rotated, with the knee of the other side will be flexed. The patients will be then immobilized at the chest and the pelvis with two adherent tapes which crossed each other at the abdomen to form a 'V' shape.

Supine percutaneous nephrolithotomy group

Procedure

The patient will remain in the supine position, with the side of interest at the edge of the table, with a small cushion placed under the flank to elevate it 15-20°.

Prone percutaneous nephrolithotomy group

Procedure

Prone percutaneous nephrolithotomy. The prone position (PRON) technique followed these classic steps: patients will be placed in a lithotomy position and a ureteral catheter will be inserted through a rigid cystoscope to perform a retrograde pyelogram. The ureteral catheter will be fixed to a Foley catheter, and then the patient will be repositioned to the prone position with pads under their shoulders.

Primary outcomes

  1. Stone clearance rate

    Time frame: 3 months postoperatively

    Comparison of stone clearance rates among different positions (flank suspended supine, supine, and prone) in Ultrasound-Guided Percutaneous Nephrolithotomy (PCNL) for the treatment of renal stones.

Secondary outcomes

  1. Operative time

    Time frame: Intraoperatively

    duration of the Ultrasound-Guided Percutaneous Nephrolithotomy (PCNL) procedure among different positions

  2. Complication rates

    Time frame: 48 hours Postoperatively

    Comparison of postoperative complications (e.g., bleeding, infection, injury) among the different positions.

  3. Stone-free rates

    Time frame: 48 hours Postoperatively

    Comparison of the percentage of patients achieving complete stone clearance among the different positions.

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

A Retrospective Single Centered Cohort Study Comparing The Effectiveness of Ultrasound-Guided PCNL Different Positions in Renal Stones Treatment

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
May 11, 2023
Registry last updated
May 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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