Kidney StoneNCT05379894
Modified Supine vs Prone Position Pnl
An observational study of Kidney Stone, run by Assiut University at 1 site in Egypt.
Trial summary
perform a comparative randomized trial comparing the efficacy and safety of percutaneous nephrolithotomy (PCNL) in the prone and modified supine positions in management of complex renal stones Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Kidney Stone
- What is being tested?
- Percutaneous nephrolithotripsy
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2022to 1 Jun 2026
- 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
- Adult, Older adult
Study population: All adult patients with renal stones candidate for operation
Who may be able to join
- Grade II - A solitary stone in the upper pole with simple anatomy or multiple stones in a patient with simple anatomy or any solitary stone in a patient with abnormal anatomy
- Grade III - Multiple stones in a patient with abnormal anatomy or, stones in a calyceal diverticulum or partial staghorn calculus
- Grade IV - Staghorn calculus or any stone in a patient with spina bifida or spinal injury.
Who cannot join
- · Pediatric group
- Grade I - A solitary stone in the mid/lower pole with simple anatomy or a solitary stone in the pelvis with simple anatomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Modified Supine vs Prone Position Percutaneous Nephrolithotripsy (PNL )in Management of Complex Renal Stones, A Randomized Comparative Study
perform a comparative randomized trial comparing the efficacy and safety of percutaneous nephrolithotomy (PCNL) in the prone and modified supine positions in management of complex renal stones
Read the detailed description
since the first successful removal of a renal calculus via a nephrostomy tract in 1976, percutaneous nephrolithotomy (PCNL) has become the preferred method of treating patients with large or complex stones.1 Traditionally, PCNL has been performed in the prone position, which allows a wide field for kidney puncture, avoids abdominal visceral injuries, and makes the puncture pathway short and straight. Multiple routes of access and the interoperative use of C-arm fluoroscopy X-ray machines may contribute to the vertical positioning of the puncture. This position provides posterior access to the collecting system, which theoretically enables the surgeon to puncture a posterior calyx through Braudel's avascular renal plane without significant parenchymal bleeding and peritoneal perforation. However, the prone position also has some disadvantages. For example, abdominal pressure decreases end expiratory lung volume and lung capacity, reducing the ability of patients to tolerate prolonged surgery, contraindicating the prone position in morbidly obese patients and individuals with some respiratory diseases.
An alternative position for PCNL consists of the modified supine position, in which patients are placed in a supine position with a water bag or specially designed cushion under the flank. The modified supine position has several advantages. Due to greater comfort, the position has a low impact on a patient's blood circulation and respiratory system. This position makes it easier for the anesthetist to monitor the patient, and it may decrease the use of anesthetics. For high-risk patients, the modified supine position can be changed to facilitate endotracheal intubation anesthesia whenever needed. Moreover, the smaller angle between the horizon and the operating channel improves the removal of crushed stones. This position also facilitates simultaneous ureteroscopy access when necessary, allowing for the combination of PCNL and the ureteroscopy in the management of complex stone diseases. The major disadvantage of the modified supine position is that the kidney is more easily pushed forward by the puncture needle and the fascial dilators, leading to the establishment of a deeper channel.
It remains unclear whether the traditional prone position or the modified supine position is optimal for PCNL. The prone position has been associated with reduced operation times and higher stone clearance rates, whereas the supine position has been associated with greater safety. The Valdivia position improved by Galdakao enables the use of flexible ureteroscopy and an ureteroscopy to treat ureteral and kidney stones at the same time, whereas the Valdivia position improved by Barts often requires X-rays combined with ultrasound for determining the puncture site, and the puncture route is longer. the investigators did not utilize the Galdakao improvement of the Valdivia position since flexible ureteroscopy was too expensive for routine use. Therefore, the investigators compared the efficacy and safety of PCNL in the traditional prone and modified supine positions.
- Conditions
- Kidney Stone
- Being tested
- Percutaneous nephrolithotripsy
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous nephrolithotripsyProcedure or surgery
Also called PNL
Extraction of kidney stones through skin using nephroscope
| Study group | Role | What they receive |
|---|---|---|
| group (1 ) Modified Supine | Modified Supine position PNL Receives: Procedure: Percutaneous nephrolithotripsy | |
| group (2) prone | Prone position PNL Receives: Procedure: Percutaneous nephrolithotripsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparing the efficacy and safety of percutaneous nephrolithotomy (PCNL) in the prone and modified supine position
number of participants completely stone-free
Measured: 4 years
comparing the efficacy and safety of percutaneous nephrolithotomy (PCNL) in the prone and modified supine position
measure amount of blood loss
Measured: 4 years
comparing the efficacy and safety of percutaneous nephrolithotomy (PCNL) in the prone and modified supine position
measure of Time of operation
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start1 Jun 2022 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Kidney StoneStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ahmed Mohamed El Taher, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05379894
- Sponsor's protocol ID
- Kidney stones , PNL
- Status last verified
- May 2022
- First submitted
- 10 May 2022
- Last updated
- 18 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gokce MI, Ibis A, Sanci A, Akinci A, Bagci U, Agaoglu EA, Suer E, Gulpinar O. Comparison of supine and prone positions for percutaneous nephrolithotomy in treatment of staghorn stones. Urolithiasis. 2017 Dec;45(6):603-608. doi: 10.1007/s00240-017-0977-y. Epub 2017 Mar 29.
PubMed 28357451McCahy P, Rzetelski-West K, Gleeson J. Complete stone clearance using a modified supine position: initial experience and comparison with prone percutaneous nephrolithotomy. J Endourol. 2013 Jun;27(6):705-9. doi: 10.1089/end.2012.0650. Epub 2013 Mar 18.
PubMed 23363334
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Supine vs Prone Position Percutaneous Nephrolithotripsy (PNL )in Management of Complex Renal Stones, A Randomized Comparative Study
- ClinicalTrials.gov ID
- NCT05379894
- Acronym / sponsor ID
- Kidney stones , PNL
- Conditions
- Kidney Stone
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 18 May 2022 (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.
perform a comparative randomized trial comparing the efficacy and safety of percutaneous nephrolithotomy (PCNL) in the prone and modified supine positions in management of complex renal stones
Detailed description
since the first successful removal of a renal calculus via a nephrostomy tract in 1976, percutaneous nephrolithotomy (PCNL) has become the preferred method of treating patients with large or complex stones.1 Traditionally, PCNL has been performed in the prone position, which allows a wide field for kidney puncture, avoids abdominal visceral injuries, and makes the puncture pathway short and straight. Multiple routes of access and the interoperative use of C-arm fluoroscopy X-ray machines may contribute to the vertical positioning of the puncture. This position provides posterior access to the collecting system, which theoretically enables the surgeon to puncture a posterior calyx through Braudel's avascular renal plane without significant parenchymal bleeding and peritoneal perforation. However, the prone position also has some disadvantages. For example, abdominal pressure decreases end expiratory lung volume and lung capacity, reducing the ability of patients to tolerate prolonged surgery, contraindicating the prone position in morbidly obese patients and individuals with some respiratory diseases.
An alternative position for PCNL consists of the modified supine position, in which patients are placed in a supine position with a water bag or specially designed cushion under the flank. The modified supine position has several advantages. Due to greater comfort, the position has a low impact on a patient's blood circulation and respiratory system. This position makes it easier for the anesthetist to monitor the patient, and it may decrease the use of anesthetics. For high-risk patients, the modified supine position can be changed to facilitate endotracheal intubation anesthesia whenever needed. Moreover, the smaller angle between the horizon and the operating channel improves the removal of crushed stones. This position also facilitates simultaneous ureteroscopy access when necessary, allowing for the combination of PCNL and the ureteroscopy in the management of complex stone diseases. The major disadvantage of the modified supine position is that the kidney is more easily pushed forward by the puncture needle and the fascial dilators, leading to the establishment of a deeper channel.
It remains unclear whether the traditional prone position or the modified supine position is optimal for PCNL. The prone position has been associated with reduced operation times and higher stone clearance rates, whereas the supine position has been associated with greater safety. The Valdivia position improved by Galdakao enables the use of flexible ureteroscopy and an ureteroscopy to treat ureteral and kidney stones at the same time, whereas the Valdivia position improved by Barts often requires X-rays combined with ultrasound for determining the puncture site, and the puncture route is longer. the investigators did not utilize the Galdakao improvement of the Valdivia position since flexible ureteroscopy was too expensive for routine use. Therefore, the investigators compared the efficacy and safety of PCNL in the traditional prone and modified supine positions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group (1 ) Modified Supine | – | Procedure: Percutaneous nephrolithotripsyModified Supine position PNL |
| group (2) prone | – | Procedure: Percutaneous nephrolithotripsyProne position PNL |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All adult patients with renal stones candidate for operation
Key inclusion criteria (3 listed)
- Grade II - A solitary stone in the upper pole with simple anatomy or multiple stones in a patient with simple anatomy or any solitary stone in a patient with abnormal anatomy
- Grade III - Multiple stones in a patient with abnormal anatomy or, stones in a calyceal diverticulum or partial staghorn calculus
- Grade IV - Staghorn calculus or any stone in a patient with spina bifida or spinal injury.
Key exclusion criteria (2 listed)
- · Pediatric group
- Grade I - A solitary stone in the mid/lower pole with simple anatomy or a solitary stone in the pelvis with simple anatomy
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 |
|---|---|---|
| Percutaneous nephrolithotripsyAlso: PNLExtraction of kidney stones through skin using nephroscope | Procedure or surgery | group (1 ) Modified Supine, group (2) prone |
Primary outcome
comparing the efficacy and safety of percutaneous nephrolithotomy (PCNL) in the prone and modified supine position
Time frame: 4 years
number of participants completely stone-free
comparing the efficacy and safety of percutaneous nephrolithotomy (PCNL) in the prone and modified supine position
Time frame: 4 years
measure amount of blood loss
comparing the efficacy and safety of percutaneous nephrolithotomy (PCNL) in the prone and modified supine position
Time frame: 4 years
measure of Time of operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Results publication: PubMed 28357451Gokce MI, Ibis A, Sanci A, Akinci A, Bagci U, Agaoglu EA, Suer E, Gulpinar O. Comparison of supine and prone positions for percutaneous nephrolithotomy in treatment of staghorn stones. Urolithiasis. 2017 Dec;45(6):603-608. doi: 10.1007/s00240-017-0977-y. Epub 2017 Mar 29.
- Results publication: PubMed 23363334McCahy P, Rzetelski-West K, Gleeson J. Complete stone clearance using a modified supine position: initial experience and comparison with prone percutaneous nephrolithotomy. J Endourol. 2013 Jun;27(6):705-9. doi: 10.1089/end.2012.0650. Epub 2013 Mar 18.
- Individual participant dataSharing planned: No
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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.
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 Kidney Stone, run by Assiut 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 18 May 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yasser Abdel salam (01064108877, ymabdelsalam@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparing the efficacy and safety of percutaneous nephrolithotomy (PCNL) in the prone and modified supine position (time frame: 4 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05379894, which also lists 2 linked publications.
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 18 May 2022; AzTrials last refreshed its copy on 27 Oct 2026.