Percutaneous NephrolithotomyNCT05855057
Effectiveness of US-Guided PCNL Different Positions in Renal Stones Treatment
An observational study of Percutaneous Nephrolithotomy and Renal Stones, run by Benha University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Percutaneous Nephrolithotomy, Renal Stones, Ultrasound Therapy; Complications
- What is being tested?
- Flank suspended supine position percutaneous nephrolithotomy, Supine percutaneous nephrolithotomy group and Prone percutaneous nephrolithotomy group
- Type of treatment
- Surgery or procedure
- How many people
- 123 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jan 2018to 20 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Patient refusal.
- Pregnant women.
- Patients with renal anomalies.
- Transplanted kidney.
- Uncorrected coagulopathy, or active infection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Flank suspended supine position percutaneous nephrolithotomy, Supine percutaneous nephrolithotomy group, Prone percutaneous nephrolithotomy group
- Medical subject headings
- Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flank suspended supine position percutaneous nephrolithotomyProcedure or surgery
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 groupProcedure or surgery
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 groupProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Flank suspended supine position percutaneous nephrolithotomy | This group included 41 patients in flank suspended supine position percutaneous nephrolithotomy. Receives: Procedure: Flank suspended supine position percutaneous nephrolithotomy | |
| Supine percutaneous nephrolithotomy group | This group included 41 patients in supine percutaneous nephrolithotomy. Receives: Procedure: Supine percutaneous nephrolithotomy group | |
| Prone percutaneous nephrolithotomy group | This group included 41 patients in prone percutaneous nephrolithotomy. Receives: Procedure: Prone percutaneous nephrolithotomy group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone clearance rate
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.
Measured: 3 months postoperatively
Secondary outcomes (3)
Operative time
duration of the Ultrasound-Guided Percutaneous Nephrolithotomy (PCNL) procedure among different positions
Measured: Intraoperatively
Complication rates
Comparison of postoperative complications (e.g., bleeding, infection, injury) among the different positions.
Measured: 48 hours Postoperatively
Stone-free rates
Comparison of the percentage of patients achieving complete stone clearance among the different positions.
Measured: 48 hours Postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start20 Jan 2018
- Primary completion20 Jan 2022
- Study completion20 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Percutaneous NephrolithotomyStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abou Elezz Abdel Fattah, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05855057
- Sponsor's protocol ID
- RC 14-4-2023
- Status last verified
- May 2023
- First submitted
- 3 May 2023
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study will be available under a reasonable request from the corresponding author
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Single Centered Cohort Study Comparing The Effectiveness of Ultrasound-Guided PCNL Different Positions in Renal Stones Treatment
- ClinicalTrials.gov ID
- NCT05855057
- Acronym / sponsor ID
- RC 14-4-2023
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 20 Jan 2018 (actual)
- Primary completion
- 20 Jan 2022 (actual)
- Study completion
- 20 Jan 2022 (actual)
- First posted
- 11 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Flank suspended supine position percutaneous nephrolithotomy | – | Procedure: Flank suspended supine position percutaneous nephrolithotomyThis group included 41 patients in flank suspended supine position percutaneous nephrolithotomy. |
| Supine percutaneous nephrolithotomy group | – | Procedure: Supine percutaneous nephrolithotomy groupThis group included 41 patients in supine percutaneous nephrolithotomy. |
| Prone percutaneous nephrolithotomy group | – | Procedure: Prone percutaneous nephrolithotomy groupThis group included 41 patients in prone percutaneous nephrolithotomy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- Patient refusal.
- Pregnant women.
- Patients with renal anomalies.
- Transplanted kidney.
- Uncorrected coagulopathy, or active infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flank suspended supine position percutaneous nephrolithotomyThe 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. | Procedure or surgery | Flank suspended supine position percutaneous nephrolithotomy |
| Supine percutaneous nephrolithotomy groupThe 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°. | Procedure or surgery | Supine percutaneous nephrolithotomy group |
| Prone percutaneous nephrolithotomy groupProne 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. | Procedure or surgery | Prone percutaneous nephrolithotomy group |
Primary outcome
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 secondary outcomes
Operative time
Time frame: Intraoperatively
Complication rates
Time frame: 48 hours Postoperatively
Stone-free rates
Time frame: 48 hours Postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
- Individual participant dataSharing planned: Yes. The study will be available under a reasonable request from the corresponding author
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Percutaneous Nephrolithotomy and Renal Stones, run by Benha University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stone clearance rate (time frame: 3 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2023; AzTrials last refreshed its copy on 7 Nov 2026.