Flexible Ureteroscopy With and Without Ureteral Access Sheath in Treatment of Large Renal Stones

Not Applicable

Completed

• Conditions: Large Renal Stones; Flexible Ureteroscopy; Ureteral Access Sheath
• Interventions: Procedure: Flexible ureteroscope without ureteral access sheath; Procedure: Flexible ureteroscope with ureteral access sheath

• Registration Number: NCT06122129
• Lead Sponsor: New Valley University

Brief Summary

The aim of this study is to evaluate the flexible ureteroscope (FURS) technique with and without ureteral access sheath (UAS).

Detailed Description

Treating a large renal stone, more than 2 cm, is changing during the last decades. Technological innovations have led to a significant improvement in flexible ureteroscopes over recent years.

Many authors have used flexible ureteroscope (FURS) with laser fragmentation as proved treating modality with high efficacy. Although percutaneous extraction of large renal stones is still the first option, it has higher and more severer complications than flexible ureteroscopy.

FURS has developed into a standard diagnostic and treatment modality for upper urinary stone disease, transitional cell carcinoma and ureteral strictures. Indeed, more recently FURS is becoming a minimally invasive competitor to percutaneous nephrolithotomy for larger kidney stones as well as an accepted modality for localized treatment of small upper urinary tract transitional cell carcinoma.

The use of ureteral access sheath (UAS) is widely recognized as a technique utilized to keep the intrarenal pressure low when performing FURS for larger and more complex stones, although some authors advocate its use for most renal stones. UASs are now produced with varying characteristics including various lengths, diameters, materials, dilator tip designs, radiopaque markers, and stiffness. However, it also rises surgical costs and may injure the ureteral wall.

Most common reasons cited by urologists for using a UAS are to facilitate repeated entrance into the ureter and collecting system (as a time-saver), lower intrarenal pressure and protection of ureteroscope and ureter when extracting stone fragments. UAS has encouraged urologists in the fragmentation of large stones; it facilitates multiple entries and stone extraction during FURS.

Study Timeline

• Study First Submitted: 2023-10-26
• Study First Submitted QC: 2023-11-02
• Study Start: 2023-11-08
• Study First Posted: 2023-11-08
• Status Verified: 2024-03
• Primary Completion: 2024-03-20
• Study Completion: 2024-03-20
• Last Update Submitted: 2024-03-21
• Last Update Posted: 2024-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• Age > 18 years old.
• Both sexes.
• Patients with upper ureter and renal stones scheduled for flexible ureteroscope.

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Exclusion Criteria

• Patients with associated distal ureteral stone, kidney transplant or any kind of urinary diversion.
• Larger stones (11 cm) where the routine use of an access sheath will be felt appropriate to aid multiple passes of the scope.
• Known ureteric strictures.
• Concomitant ureteric stones.
• Patients with narrow ureter where ureteral access sheath was anticipated to be difficult.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Flexible ureteroscope without ureteral access sheath	Flexible ureteroscope without ureteral access sheath	Stones will be treated by flexible ureteroscope without ureteral access sheath
Flexible ureteroscope with ureteral access sheath	Flexible ureteroscope with ureteral access sheath	Stones will be treated by flexible ureteroscope with ureteral access sheath

Primary Outcome Measures

Name	Time	Method
Operative time	Intraperatively	Time from sterilization till the end of surgery

Secondary Outcome Measures

Name	Time	Method
Number of patients who need ancillary procedures	28 days after intervention	Need for Ancillary Procedures if there was residual.
Stone-free rate	28 days after intervention	Stone-free status was defined as no residual stones or residual stones with a maximum diameter ≤ 4 mm with no clinical symptoms at 1 month after the procedure
Duration of stay	28 days after intervention	Time from admission till hospital discharge
Complications	28 days after intervention	Complications such as mucosal lacerations, bleeding, urosepsis, and stein Strasse.

Trial Locations

Locations (1)

New Valley University; 🇪🇬 New Valley, Egypt