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

May 3, 2023 updated by: Ahmed Abou Elezz Abdel Fattah, Benha University

A Retrospective Single Centered Cohort Study Comparing The Effectiveness of Ultrasound-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.

Study Overview

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

123

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Benha, Egypt
        • Benha University Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

123 patients who underwent Percutaneous nephrolithotomy at the period from 2018 to 2022 and were diagnosed with consecutive, adult obese patients (age >18-70 years) with renal stones diameter ≥2 cm

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Flank suspended supine position percutaneous nephrolithotomy
This group included 41 patients in flank suspended supine position percutaneous nephrolithotomy.
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
This group included 41 patients in supine percutaneous nephrolithotomy.
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
This group included 41 patients in prone percutaneous nephrolithotomy.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operative time
Time Frame: Intraoperatively
duration of the Ultrasound-Guided Percutaneous Nephrolithotomy (PCNL) procedure among different positions
Intraoperatively
Complication rates
Time Frame: 48 hours Postoperatively
Comparison of postoperative complications (e.g., bleeding, infection, injury) among the different positions.
48 hours Postoperatively
Stone-free rates
Time Frame: 48 hours Postoperatively
Comparison of the percentage of patients achieving complete stone clearance among the different positions.
48 hours Postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2018

Primary Completion (Actual)

January 20, 2022

Study Completion (Actual)

January 20, 2022

Study Registration Dates

First Submitted

May 3, 2023

First Submitted That Met QC Criteria

May 3, 2023

First Posted (Estimate)

May 11, 2023

Study Record Updates

Last Update Posted (Estimate)

May 11, 2023

Last Update Submitted That Met QC Criteria

May 3, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The study will be available under a reasonable request from the corresponding author

IPD Sharing Time Frame

One year after the end of the study.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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