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

NCT ID: NCT06122129

Last Updated: 2024-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-08
• Study Completion Date: 2024-03-20

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.

Conditions

Flexible Ureteroscopy; Ureteral Access Sheath; Large Renal Stones

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Flexible ureteroscope with ureteral access sheath

Stones will be treated by flexible ureteroscope with ureteral access sheath

Group Type: EXPERIMENTAL

Flexible ureteroscope with ureteral access sheath

Intervention Type: PROCEDURE

The flexible ureteroscope either directly or via an access sheath, depending on the size of the ureter, a 9.5/11.5 Fr or a 12 Fr access sheath will be used.

Flexible ureteroscope without ureteral access sheath

Stones will be treated by flexible ureteroscope without ureteral access sheath

Group Type: ACTIVE_COMPARATOR

Flexible ureteroscope without ureteral access sheath

Intervention Type: PROCEDURE

Ureteroscopy will be carried out without a ureteral access sheath

Interventions

Flexible ureteroscope with ureteral access sheath

The flexible ureteroscope either directly or via an access sheath, depending on the size of the ureter, a 9.5/11.5 Fr or a 12 Fr access sheath will be used.

Intervention Type: PROCEDURE

Flexible ureteroscope without ureteral access sheath

Ureteroscopy will be carried out without a ureteral access sheath

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

New Valley University

OTHER

Sponsor Role: lead

Responsible Party

Waheed Fawzy Abdelrasol

Lecturer of Urology, faculty of medicine, New Vally University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

New Valley University

New Valley, New Valley Governorate, Egypt

Countries

Egypt

Other Identifiers

0739-20233

Identifier Type: -

Identifier Source: org_study_id