Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
ID07342361

Using Bendable Tip-suction Ureteral Access Sheath Compared to Conventional Sheath in Managing Renal Staghorn Stones A Randomized Prospective Study

Led by Helwan University · Updated on 2026-02-03

100

Participants Needed

1

Research Sites

7 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to compare the safety and effectiveness of two types of ureteral access sheaths used during retrograde intrarenal surgery (RIRS) for managing staghorn renal stones. Staghorn renal calculi are complex kidney stones that fill the renal pelvis and branch into the kidney's calyces. Although percutaneous nephrolithotomy is the standard treatment, RIRS is a less invasive option increasingly used, especially for patients unsuitable for the traditional approach. The study evaluates whether a new bendable tip-suction sheath improves surgical outcomes compared to a conventional sheath. Participants will undergo retrograde intrarenal surgery using either a bendable tip-suction ureteral access sheath connected to a suction system or a conventional ureteral access sheath. The bendable sheath is designed to reach targeted kidney areas more effectively, maintain a clear view by continuous suction, and remove stone fragments during laser lithotripsy. The study randomly assigns patients to one of these two groups to assess differences in safety and efficiency. During the study, patient safety will be monitored from surgery through one month afterward to evaluate the surgical technique's safety. The effectiveness of the surgery will be measured one month post-operation. Participants will be assessed with renal function tests and followed for any complications, with data collected on surgical outcomes and recovery. The total participation duration includes the surgery and follow-up period of at least one month.

CONDITIONS

Brief Title

Using Retrograde Intrarenal Surgery for Managing Staghorn Renal Stones.

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients of both sexes
  • Patient has a staghorn renal stone (complete or partial staghorn)
  • Normal renal function tests
  • Congenital renal anomalies such as horseshoe, pelvic, or mal-rotated kidneys
Not Eligible

You will not qualify if you...

  • Abnormal coagulation profile
  • Active or untreated urinary tract infection
  • Age under 18 years or above 70 years
  • Staghorn stone associated with other pathology requiring additional intervention, such as ureteral stricture or ureteropelvic junction obstruction
  • Pregnancy

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - During surgery to one month after surgery

Participants undergo retrograde intrarenal surgery using either a bendable tip-suction ureteral access sheath or a conventional ureteral access sheath to manage renal staghorn stones.

1 surgical procedure and follow-up visits up to 1 month

Trial Site Locations

Total: 1 location

1

Faculty of medicine, Helwan University

Cairo, Egypt, 11795

Actively Recruiting

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Research Team

A

Ahmed H Elsergany, MSc.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Percutaneous nephrolithotomy versus retrograde intrarenal surgery for the treatment of kidney stones up to 2 cm in patients with solitary kidney: a single centre experience.

Yunjin Bai, Xiaoming Wang, Yubo Yang...

https://pubmed.ncbi.nlm.nih.gov/28100225

Application of tip-bendable ureteral access sheath in flexible ureteroscopic lithotripsy: an initial experience of 224 cases.

Hui Liang, Lijian Liang, Yiwei Lin...

https://pubmed.ncbi.nlm.nih.gov/37915008

European Association of Urology Section of Urolithiasis and International Alliance of Urolithiasis Joint Consensus on Retrograde Intrarenal Surgery for the Management of Renal Stones.

Guohua Zeng, Zhijian Zhao, Giorgio Mazzon...

https://pubmed.ncbi.nlm.nih.gov/34836838