- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05855057
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
Status
Completed
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
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Benha, Egypt
- Benha University Hospitals
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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 |
|---|---|
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Flank suspended supine position percutaneous nephrolithotomy
This group included 41 patients in flank suspended supine position percutaneous nephrolithotomy.
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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.
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Supine percutaneous nephrolithotomy group
This group included 41 patients in supine percutaneous nephrolithotomy.
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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°.
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Prone percutaneous nephrolithotomy group
This group included 41 patients in prone percutaneous nephrolithotomy.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Stone clearance rate
Time Frame: 3 months postoperatively
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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.
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3 months postoperatively
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Operative time
Time Frame: Intraoperatively
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duration of the Ultrasound-Guided Percutaneous Nephrolithotomy (PCNL) procedure among different positions
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Intraoperatively
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Complication rates
Time Frame: 48 hours Postoperatively
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Comparison of postoperative complications (e.g., bleeding, infection, injury) among the different positions.
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48 hours Postoperatively
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Stone-free rates
Time Frame: 48 hours Postoperatively
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Comparison of the percentage of patients achieving complete stone clearance among the different positions.
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48 hours Postoperatively
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC 14-4-2023
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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