A Comparative Study Between the Usage of Flexible and Navigable Suction Ureteral Access Sheath (FANS) Versus Traditional Access Sheath in RIRS : Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

A comparative study between the Usage of Flexible and Navigable Suction Ureteral Access Sheath (FANS) versus Traditional Access sheath in RIRS : Randomized controlled trial .

Eligibility
Participation Requirements
Sex: All
Minimum Age: 14
Healthy Volunteers: f
View:

• Age ≥14 years old in patients not known to have stone forming medical conditions.

• Renal stones diameter of ≤2 cm confirmed by CT with all types of configurations (branching \& non-branching).

• Non - recurrent cases with no history of previous open renal surgeries or PCNL with normal renal anatomy.

• Patients with non - infected urine analysis.

Locations
Other Locations
Egypt
Cairo university hospitals
RECRUITING
Cairo
Contact Information
Primary
Yosseif Ammar, MBBCH
yosefelhousseiny@gmail.com
201226912630
Backup
Ahmed Yehia Abdelaziz Mohammed, Professor of urology
mailto:dr_ahmedyehia81@yahoo.com
201229793766
Time Frame
Start Date: 2025-06-01
Estimated Completion Date: 2025-12-01
Participants
Target number of participants: 80
Treatments
Active_comparator: Using FANS
After the successful induction of anesthesia, the lithotomy position will be adopted. Ureteroscopy will be used with the aid of a safety guidewire to evaluate the condition of the ureter. The serial dilation of the ureter using ureteral dilators up to 14 Fr . The FANS will be then inserted into the ureter under the guidance of the safety guidewire. The FANS tip will be positioned in the renal pelvis or calyces near the location of the stone.~The FANS will be connected to a vacuum device, and the negative pressure will be applied. The actual intraoperative negative pressure value will be adjusted by the urologist through a pressure adjustment vent as needed. The irrigation volume was set using peristaltic pumps. Lithotripsy will be conducted using the holmium: yttrium aluminum garnet laser applying the dusting technique of laser lithotripsy. During lithotripsy, the FANS will allow us to retrieve most of the fragmented stone particles by application of the suction pressure. All cases w
Active_comparator: Using traditional UAS
The method of anesthesia, patient positioning, ureteral dilation, and lithotripsy were the same as those used in the FANS group.~For the traditional UAS group, the end of the UAS will be positioned underneath the ureteropelvic junction (UPJ). The irrigation volume is applied using peristaltic pumps. The dusting technique of laser lithotripsy will be applied to the stones.~All cases will be stented using JJ stents with the suitable size.
Related Therapeutic Areas
Sponsors
Leads: Yosseif elhousseiny ammar ahmed

This content was sourced from clinicaltrials.gov

Similar Clinical Trials