Comparing Mini-Percutaneous Nephrolithotomy and Flexible Ureteroscopy with Suction Sheath for Removing 2-3 cm Kidney Stones
Led by Ain Shams University · Updated on 2025-12-29
120
Participants Needed
1
Research Sites
4 weeks
Total Duration
AI-Summary
What this Trial Is About
This research aims to compare the safety and effectiveness of two minimally invasive surgical methods for removing kidney stones sized 2 to 3 centimeters. The study is designed as a randomized controlled trial to evaluate which approach results in a higher stone-free rate after surgery. Researchers also plan to assess differences in surgery time, hospital stay length, and complication rates between the two options.
One treatment, Mini-Percutaneous Nephrolithotomy Mini-PCNL, involves creating a small opening in the back to access the kidney directly with a miniature scope for stone removal. The other method, Flexible Ureteroscopy FURS with a tip-bendable suction sheath, uses a flexible scope passed through the urinary tract, enhanced by integrated suction to help clear stone fragments. Both procedures are performed under general anesthesia, with detailed surgical steps including stent placement after surgery to aid healing.
Participants will undergo assigned surgery and be monitored with imaging one month post-operation to measure stone clearance. Researchers will track operative time and length of hospital stay. Follow-up includes clinical assessments and imaging to evaluate safety and effectiveness. The total study duration extends until September 2026, with detailed evaluations to guide improved surgical management of kidney stones.
CONDITIONS
Brief Title
Comparison Between Two Methods for Renal Stone Treatment Mini Percutaneous Nephrolithotomy and Flexible Ureteroscopy With Suction Sheath
Research Team
M
Mohamed M Hasab Allah, resident
A
Ahmed Higazy, Lecturer of Urology
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Patients with renal stones between 2-3 cm in size confirmed by CT scan.
You will not qualify if you...
Patients with previous ureteric injury.
Patients with uncontrolled diabetes mellitus or hypertension.
Patients with uncontrolled hepatic dysfunction.
Patients with uremia or renal failure.
Pregnant patients.
Patients with active urinary tract infection.
Patients with bleeding tendency or uncontrolled coagulopathy.
Patients with congenital anomalies such as horse-shoe kidney and pelvi-ureteric junction obstruction.
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Single procedure with 4 weeks of stent placement
Participants receive either mini-percutaneous nephrolithotomy or flexible ureteroscopy with a tip-bendable suction sheath under general anesthesia to remove kidney stones. The procedures involve insertion of catheters and scopes to fragment and remove stones, followed by placement of a ureteral stent for 4 weeks.
1 procedure visit (in-person)
Follow-up
Duration - Up to 1 month after surgery
Participants are monitored post-procedure to assess stone clearance and recovery, including removal of the ureteral stent and evaluation of hospital stay and operative outcomes.
Approximately 1 to 2 follow-up visits (in-person)
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Could Use of a Flexible and Navigable Suction Ureteral Access Sheath Be a Potential Game-changer in Retrograde Intrarenal Surgery? Outcomes at 30 Days from a Large, Prospective, Multicenter, Real-world Study by the European Association of Urology Urolithiasis Section.
Comparative efficacy between retrograde intrarenal surgery with vacuum-assisted ureteral access sheath and minimally invasive percutaneous nephrolithotomy for 1-2 cm infectious upper ureteral stones: a prospective, randomized controlled study.
Retrograde intrarenal surgery of renal stones: a critical multi-aspect evaluation of the outcomes by the Turkish Academy of Urology Prospective Study Group (ACUP Study).
Tip bendable suction ureteral access sheath versus traditional sheath in retrograde intrarenal stone surgery: an international multicentre, randomized, parallel group, superiority study.