AzTrials
AzTrials

Kidney Calculi (or Renal Calculi / Nephrolithiasis)SUPRO-PEDNCT07887945

Supine vs. Prone Mini-PCNL in Children

A study testing Group A and Group B in people with Kidney Calculi (or Renal Calculi / Nephrolithiasis) and Supine Mini Percutaneous Nephrolithotomy, run by Fayoum University Hospital at 1 site in Egypt.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Percutaneous nephrolithotomy (PCNL) is an established intervention for large or ESWL-resistant renal stones in pediatric populations. While traditionally performed in the prone position, the supine position offers potential advantages, including simpler patient positioning, easier airway management, better ergonomics… Read more about this study

Who is it for?
Ages 6 months to 15 years
What is being tested?
Group A and Group B
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteEgypt
Study dates
5 Oct 2026to 15 Aug 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 6 months to 15 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Children under 15 years old (both sexes).
  • Diagnosed with a single renal pelvis stone, or middle/lower calyceal stone.
  • Stone size ranging from 10 mm up to 30 mm (measured via non-contrast CT).

Who cannot join

  • Congenital renal anomalies (e.g., horseshoe kidney, ectopic pelvic kidney, crossed fused ectopia, UPJ obstruction, or ureteric stricture).
  • Staghorn stones or upper calyceal stones.
  • Active urinary tract infection (UTI).
  • Bleeding disorders or uncorrected coagulopathy.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Egypt1 site, 1 recruiting
  • Mohamed Mahmoud Dogha

    Al Fayyum, Keman Fares, 63514

    Mohamed Mahmoud Dogha, assistant professor of urology, +2 01010044612, mma16@fayoum.edu.eg

    Recruiting

Other trials in Egypt

About this study

Official title: Supine Versus Prone Mini Percutaneous Nephrolithotripsy for Renal Stone Less Than 3 cm in Children Less Than 15 Years Old: A Prospective Randomized Trial

Percutaneous nephrolithotomy (PCNL) is an established intervention for large or ESWL-resistant renal stones in pediatric populations. While traditionally performed in the prone position, the supine position offers potential advantages, including simpler patient positioning, easier airway management, better ergonomics, and shorter operative duration. This prospective randomized trial compares the safety, efficacy, operative time, complication rates, and stone-free rates between supine and prone mini-percutaneous nephrolithotripsy (Mini-PCNL) in children under 15 years of age presenting with single renal stones measuring 10 to 30 mm.

Read the detailed description

Introduction

Pediatric urinary stones could be managed effectively using minimally invasive treatment modalities such as extracorporeal shock wave lithotripsy (ESWL), retrograde intrarenal surgery (RIRS), and percutaneous nephrolithotomy (PCNL). But PCNL had a significant role in cases with large and/or ESWL resistant stones. The European Association of Urology guidelines recommended PCNL as the primary treatment option for large renal stones (> 20 mm) and also for > 10 mm stones in the lower renal pole (Ozden E et al., 2016).

Percutaneous nephrolithotomy (PCNL) is the gold procedure for large stones and complex kidney disorder treatment, but its morbidity was the highest between different stone treatments. For minimizing complication rates, surgeons must develop different variations of the classic prone position where PCNL is usually performed; one of them is the supine position (Mourmouris P et al., 2018). PCNL mostly performed in the prone position, but the supine position has proven to be a better option with several advantages. PCNL in the supine position has a similar success rate and a shorter operative time than conventional PCNL (Desoky E et al., 2018).

Supine PCNL enables a single positioning through the operation, with easy patient ventilation and protection from positional injuries, with convenient access to the patient by the anesthesiologist, and also improves the ergonomic environment for the surgical urologist (who may be seated while operating) and easy endoscopic combined intrarenal surgery (ECIRS) if needed (Sofer M et al., 2017).

The advantages of the supine position lead to considering supine PCNL the gold standard for urologists worldwide, and it is still considered a new, not an alternative, position (Valdivia-Urìa J et al., 2011).

Aim of the Study

This study aims to compare safety \& outcomes, such as operative time, complication rates, and stone-free rates in the prone position versus the supine position in mini-percutaneous nephrolithotripsy (Mini-PCNL) in children less than 15 years old for renal stones less than 3 cm.

Patients and methods

This study will include 50 patients with renal stones less than 3 cm scheduled for PCNL admitted to the Urology Department, Fayoum University. The patients will be prospectively randomized into two groups (with a ratio of 1:1, 25 patients per group).

  • Group A for mini percutaneous nephrolithotripsy in the supine position.
  • Group B for mini percutaneous nephrolithotripsy in the prone position.

Inclusion criteria

  1. Patients diagnosed with single renal pelvis stones or middle or lower calyceal stones.
  2. Stone size ranged from 10 mm up to 30 mm.
  3. Children less than 15 years old, both sexes.

Exclusion criteria:

  1. Patients with renal anomalies such as horseshoe kidney, ectopic pelvic kidney, crossed fused renal ectopia, UPJ obstruction, or ureteric stricture.
  2. Patients with staghorn stones or upper calyceal stones.
  3. Patients with active urinary tract infection.
  4. Patients with bleeding disorders.

Sample Size

The sample size was calculated using G*Power software version 3.1.9.7. Based on data reported by Abdel Ghani et al. (2024), the mean operative time was 65.2 ± 9.6 minutes in the supine Mini-PCNL group and 82.6 ± 10 minutes in the prone Mini-PCNL group. Using a two-tailed independent samples t-test, an alpha error of 0.05, and a study power of 80%, the minimum required sample size was a total of 28 participants, which is equivalent to 14 patients per group. To account for potential dropouts and improve statistical validity, a total of 50 participants (25 per group) will be enrolled.

Preoperative assessment

All patients will be evaluated with a full medical \& surgical history and a general \& abdominal and local examination focusing on:

  • Upper urinary tract symptoms.
  • Previous surgical procedures (open or endoscopy ).

Laboratory Investigations

  • Urine analysis, culture, and sensitivity.
  • Complete blood count (CBC) .
  • Coagulation profile (I.N.R, PT, PTT).
  • Kidney function tests: blood urea and serum creatinine.
  • Liver functions test; ALT, AST, ALP, albumin, and bilirubin.

Radiological Examination

  • Pelvic-abdominal ultrasound.
  • Kidney-ureters-bladder X-ray (KUB) .
  • Non Contrast Spiral Computed Tomography (NCSCT) for :
  • Measuring stone size, site, distribution, and HU.
  • Pelvi-calyceal anatomy .
  • Relation of the kidney to the related organs.

Operative technique Patients will be given prophylactic intravenous antibiotics (cefoperazone50-100mg/kg) were administered 1 hours preoperatively.

Positioning: In the two groups:

Cystoscopy will be performed in the lithotomy position by pediatric cystoscopy, the ureteral orifice will be identified and a 0.025 inch guide wire will be introduced; the wire will be advanced under fluoroscopic guidance to the level of pelvicalyceal system, 5F or 6F open-ended ureteral catheter will be advanced over the wire and the guide wire will be removed, leaving the ureteral catheter in place, a retrograde ureteropyelography will be done, and a ureteral catheter will be fixed with tape to an appropriate Foley's catheter.

In Group A: Patients were kept in Supine position using a suitable cushion (water bag) under the ipsilateral shoulder, fixing the ipsilateral arm over the thorax, then crossing the extended patient ipsilateral leg over the contralateral leg, all pressure points were checked carefully and padded.

In Group B: Patients were placed in the Prone position, and all pressure points are checked carefully and padded. A pillow was placed under the chest and another pillow was placed under the symphysis as a support to allow optimal ventilation.

Technical aspect (in both groups):

A preplanned tract or tracts are designed along the maximum stone burden so that these tracts are punctured and safety wires are inserted before dilatation, The skin will be punctured posteriorly to the posterior axillary line by 18G puncture needle and, the track will be dilated sequentially using fascial dilators and a 16Fr amplatz sheath will be advanced over its metal dilator under fluoroscopic, 16Fr amplatz sheath will be positioned, allowing the introduction of 8.5 to 11Fr semi-rigid ureteroscope.

The warmed Saline 0.9% will be used for irrigation at a suitable height from the level of the operating table, Stones will be fragmented using power (1.6-1.8 joule) and frequency (8-10 hertz) Ho:YAG laser with a 550-μm fiber laser lithotriptor and large fragments will be retrieved by grasper and stone are dusting using low power ( 0.8-1.0 joule) and high frequency(15-20 hertz) Ho:YAG laser and by The popcorn' technique for the small one.

Nephrostomy catheter 14Fr will be inserted at the end of the procedure under fluoroscopic guidance, the nephrostomy is secured at the skin with a silk suture, and the wound is dressed, The appropriate Antigrade double-J stent will be routinely maintained in place following the procedure.

Intraoperative Data In the operation record, the operative time; calculated from the beginning of ureteral catheterization to the nephrostomy tube placement, the position time from the end of ureteral catheter insertion to the beginning of puncture, access time defined as the time from the beginning of puncturing of the skin to establish the tract, fluoroscopy time defined as time was patient exposed to radiation .and LASER time as defined the time use LASER to fragments and dusting stone. Any requirements for blood transfusion, any complications within the operation or number of punctures will be recorded.

Postoperative Period \& Follow-up All patients will be observed in the recovery room for 30-60 minutes. Nephrostomy tube will be clamped in the first 2h post-operatively then opened till 24h post-operative day and will be removed in the second post-operative day if there is no indication for a second look or any signs of early infection.

Post-operative complete blood count (CBC), serum creatinine (S.cr) and C- reactive protein (CRP) tests will be done for all patients in first 24h. KUB will be done in the 2nd post-operative day for evaluation of the radiopaque residual fragments, and position of the double-J stent in addition to non contrast spiral Computer tomography (NCSCT) will be done post-operatively for measuring of radiolucent residual fragments.

The patients would be considered free of stones if there were no detected residual fragments less than 4mm in largest dimension (Zhong F, Alberto G et al., 2018). For residual fragments measuring 4-10 mm will be referred for ESWL after 2 weeks, and for residual fragments more than 10mm 2nd look PCNL will be planned after 1 week post-operatively.

Urethral catheter will be removed after 48h post-operatively and double-J stent will be removed after one month. Post-operative antibiotics (cefoperazone 50-100mg/kg) will be routinely continued twice daily for 5days.

Urine analysis and urine culture \& sensitivity will be done for all patients after 2 weeks post-operatively.

All patients will be observed for 2 weeks post-operatively for any Complications such as hematuria, any signs of infection, urinary leakage, renal colic, and symptoms of peritonitis.

Statistical analysis

Analysis of data was carried out using the statistical package of social science (SPSS version 20). Description of quantitative variables was given as mean, and standard deviation. Chi square test ( χ2 -test) was used to compare qualitative variables between groups. The t-test was used to compare quantitative variables in parametric data. The Z-test was used for proportions. P-values less than 0.05 will be considered significant and P values less than 0.01 were considered highly significant.

Ethical Consideration:

All the individuals and their familes included in the study will be informed about the procedures regarding the study and will be informed of their rights to refuse participation or withdraw from the study without having to give reasons. Participants were guaranteed anonymity and all information provided would be treated with confidentiality.

The required administrative regulations will be fulfilled according to the ethical approval of the Faculty of Medicine, Fayoum University Scientific Research Ethics Committee.

Being tested
Group A, Group B
Keywords
supine, mini-PNL, prone, nephrolithotomy
Medical subject headings
Kidney Calculi, Nephrolithiasis, Deception

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Group AProcedure or surgery

    Also called Supine Mini-PCNL

    Mini-PCNL (16Fr Amplatz sheath, 8.5-11Fr ureteroscope, Ho:YAG laser) performed in the supine position using a cushion under the ipsilateral shoulder.

  • Group BProcedure or surgery

    Also called Prone Mini-PCNL

    Mini-PCNL (16Fr Amplatz sheath, 8.5-11Fr ureteroscope, Ho:YAG laser) performed in the conventional prone position with chest and symphysis support.

Study groups in NCT07887945
Study groupRoleWhat they receive
Group A Procedure/Surgery: Supine Mini-PCNLExperimentalMini-PCNL (16Fr Amplatz sheath, 8.5-11Fr ureteroscope, Ho:YAG laser) performed in the supine position using a cushion under the ipsilateral shoulder.
Receives: Procedure: Group A
Group B Procedure/Surgery: Prone Mini-PCNLActive comparatorMini-PCNL (16Fr Amplatz sheath, 8.5-11Fr ureteroscope, Ho:YAG laser) performed in the conventional prone position with chest and symphysis support.
Receives: Procedure: Group B

What is being measured

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

  1. Operative Time

    Total duration of the surgical procedure measured in minutes.

    Measured: Intraoperatively (from initial skin incision to final skin closure)

  2. Stone-Free Rate (SFR)

    Percentage of patients with complete absence of stones or residual fragments < 4 mm, assessed via non-contrast CT or KUB X-ray.

    Measured: 1 month post-surgery

Secondary outcomes (2)
  1. Complication Rate

    Rate and severity of complications classified via the modified Clavien-Dindo system.

    Measured: Intraoperatively through 30 days post-surgery

  2. Positioning Time

    Duration required to position and pad the patient in either the supine or prone position.

    Measured: Intraoperatively (from completion of ureteral catheter insertion to initial skin puncture)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2026
  2. Study start5 Oct 2026
  3. Primary completion1 Aug 2027 (estimated)
  4. Study completion15 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07887945
Sponsor's protocol ID
M-945
Acronym
SUPRO-PED
Status last verified
Oct 2026
First submitted
5 Oct 2026
Last updated
22 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Group A and Group B in people with Kidney Calculi (or Renal Calculi / Nephrolithiasis) and Supine Mini Percutaneous Nephrolithotomy, run by Fayoum University Hospital 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 4 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: looking for participants now, as of the sponsor's last update on 22 Oct 2026. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Operative Time (time frame: Intraoperatively (from initial skin incision to final skin closure)). The study lists 2 primary outcomes in all. 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 22 Oct 2026.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in