Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07306819

Flexible Ureteroscopy Using a Tip-Bendable Suction Ureteral Access Sheath Versus Mini-Percutaneous Nephrolithotomy for Treatment of 2-3 cm Renal Stones: A Randomized Controlled Trial

Led by Ain Shams University · Updated on 2025-12-29

120

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients aging 18 years old or more.
  • Patients with renal stones between 2-3 cm in size confirmed by CT scan.
Not Eligible

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.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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)

Trial Site Locations

Total: 1 location

1

Ain shams university hospitals

Cairo, Egypt

Actively Recruiting

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Research Team

M

Mohamed M Hasab Allah, resident

A

Ahmed Higazy, Lecturer of Urology

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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Frequently Asked Questions

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Published Research Related To This Trial

Tip bendable suction ureteral access sheath versus traditional sheath in retrograde intrarenal stone surgery: an international multicentre, randomized, parallel group, superiority study.

Wei Zhu, Shusheng Liu, Jianwei Cao...

https://pubmed.ncbi.nlm.nih.gov/39070176

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.

Qing-Lai Tang, Ping Liang, Ye-Fei Ding...

https://pubmed.ncbi.nlm.nih.gov/37483661

A Practical Guide for Intra-Renal Temperature and Pressure Management during Rirs: What Is the Evidence Telling Us.

Felipe Pauchard, Eugenio Ventimiglia, Mariela Corrales...

https://pubmed.ncbi.nlm.nih.gov/35743499

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).

Selcuk Guven, Pakize Yigit, Altug Tuncel...

https://pubmed.ncbi.nlm.nih.gov/32347334

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.

Vineet Gauhar, Olivier Traxer, Daniele Castellani...

https://pubmed.ncbi.nlm.nih.gov/38789313