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

NCT06122129 | Completed

• 1 other identifier: 0739-20233
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Flexible Ureteroscopy; Ureteral Access Sheath; Large Renal Stones

Outcome Measures

Primary Outcomes (1)

• Operative time

  Time from sterilization till the end of surgery

  Intraperatively

Secondary Outcomes (4)

• Stone-free rate

  28 days after intervention

• Complications

  28 days after intervention

• Duration of stay

  28 days after intervention

• Number of patients who need ancillary procedures

  28 days after intervention

Study Arms (2)

Flexible ureteroscope with ureteral access sheath

EXPERIMENTAL

Stones will be treated by flexible ureteroscope with ureteral access sheath

Procedure: Flexible ureteroscope with ureteral access sheath

Flexible ureteroscope without ureteral access sheath

ACTIVE COMPARATOR

Stones will be treated by flexible ureteroscope without ureteral access sheath

Procedure: Flexible ureteroscope without ureteral access sheath

Interventions

Flexible ureteroscope with ureteral access sheath 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 with ureteral access sheath

Flexible ureteroscope without ureteral access sheath PROCEDURE

Ureteroscopy will be carried out without a ureteral access sheath

Flexible ureteroscope without ureteral access sheath

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• New Valley University: lead

Study Sites (1)

New Valley University

New Valley, New Valley Governorate, 72511, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Urology, faculty of medicine, New Vally University

Study Record Dates

• First Submitted: October 26, 2023
• First Posted: November 8, 2023
• Study Start: November 8, 2023
• Primary Completion: March 20, 2024
• Study Completion: March 20, 2024
• Last Updated: March 22, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)