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Kidney StoneNCT05379894

Modified Supine vs Prone Position Pnl

An observational study of Kidney Stone, run by Assiut University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Yasser Abdel salam contact

01064108877

ymabdelsalam@aun.edu.eg

Ahmed Shehata El Azab contact

01060035979

elazab@aun.edu.eg

Egypt1 site, 1 recruiting
  • Assuit facility of medicine

    Asyut, Assuit

    Recruiting

Other trials in Egypt

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 groups in NCT05379894
Study groupRoleWhat they receive
group (1 ) Modified SupineModified Supine position PNL
Receives: Procedure: Percutaneous nephrolithotripsy
group (2) proneProne position PNL
Receives: Procedure: Percutaneous nephrolithotripsy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

  2. comparing the efficacy and safety of percutaneous nephrolithotomy (PCNL) in the prone and modified supine position

    measure amount of blood loss

    Measured: 4 years

  3. 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.

  1. First posted18 May 2022
  2. Study start1 Jun 2022 (estimated)
  3. Primary completion1 Jun 2025 (estimated)
  4. Study completion1 Jun 2026 (estimated)

Resources

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)
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 28357451
  • McCahy 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

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.

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