The Impact of Suction-Assisted RIRS (DISS Versus FANS) on Postoperative Infection Rate and Stone-Free Rate After Treatment of Medium Sized Renal Stones
| Registry | NCT07516535 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 126 (Estimated) |
| Sponsor | Ain Shams University (Other) |
| Conditions | Kidney Stones, Nephrolithiasis, Renal Calculi |
| Interventions | Direct In-Scope Suction, Flexible and Navigable Suction Ureteric Access Sheath (Procedure) |
| Dates | start 2026-04-30 (estimated), primary completion 2027-04-30 (estimated), completion 2027-04-30 (estimated), first posted 2026-04-08, last updated 2026-04-08 |
| Locations | 1 site in Egypt |
Related Papers Related Patents Related Grants Related Experts
All trials for Kidney Stones All trials for Nephrolithiasis All trials of Direct In-Scope Suction All trials of Flexible and Navigable Suction Ureteric Access Sheath
Kidney stones are a common health problem and may recur frequently, which can affect quality of life and kidney function. Retrograde intrarenal surgery (RIRS) is a minimally invasive treatment used for renal stones, but treatment of medium-sized stones may be associated with longer operative time, impaired visibility during surgery, residual stone fragments, and postoperative infectious complications caused by increased intrarenal pressure.
Suction-assisted retrograde intrarenal surgery (RIRS) techniques have been developed to improve surgical efficiency and safety by facilitating continuous removal of stone fragments and helping control intrarenal pressure. Two commonly used suction-assisted approaches are direct in-scope suction (DISS) and flexible and navigable suction ureteric access sheath (FANS). However, there is limited prospective randomized evidence directly comparing these two techniques.
This randomized prospective clinical study aims to compare direct in-scope suction (DISS) versus flexible and navigable suction ureteric access sheath (FANS) in adult patients with medium-sized renal stones measuring 2 to 3 cm who are undergoing retrograde intrarenal surgery (RIRS). Participants will be randomly assigned to one of the two suction-assisted techniques. The study will evaluate whether flexible and navigable suction ureteric access sheath (FANS) provides better outcomes than direct in-scope suction (DISS) in terms of stone-free rate and postoperative infection rate.
The primary outcome is stone-free status assessed by postoperative imaging. Secondary outcomes include operative time, intraoperative visibility, and postoperative complications, particularly infection and urosepsis. The study hypothesis is that suction-assisted retrograde intrarenal surgery (RIRS) using the flexible and navigable suction ureteric access sheath (FANS) technique will result in a higher stone-free rate and a lower postoperative infection rate compared with direct in-scope suction (DISS) in the management of medium-sized renal stones.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| In-Scope Suction Group | Experimental | Procedure: Direct In-Scope Suction | Participants assigned to this arm will undergo suction-assisted retrograde intrarenal surgery using direct in-scope suction. A single-use flexible ureteroscope with suction function will be used, and direct suction will be applied through the working channel during laser lithotripsy. Negative pressure will be maintained between 2 and 7 kilopascals and adjusted intraoperatively according to visibility and fragment evacuation. Laser lithotripsy will be performed using a holmium:yttrium-aluminum-garnet laser with dusting and popcorn techniques, followed by placement of a 6 French double-J ureteral stent. |
| Flexible and Navigable Suction Ureteric Access Sheath Group | Experimental | Procedure: Flexible and Navigable Suction Ureteric Access Sheath | Participants assigned to this arm will undergo suction-assisted retrograde intrarenal surgery using a flexible and navigable suction ureteric access sheath. The sheath will be inserted under guidewire guidance and connected to a vacuum device. Negative pressure will be maintained between 2 and 7 kilopascals and adjusted intraoperatively according to visibility and fragment evacuation. Laser lithotripsy will be performed using a holmium:yttrium-aluminum-garnet laser with dusting and popcorn techniques. Suction will be applied intermittently through the sheath to facilitate fragment evacuation, followed by placement of a 6 French double-J ureteral stent. |
Sex: All, ages: 18 Years to 60 Years
Inclusion Criteria: * Adults aged 18 to 60 years * Radiologically confirmed renal stones measuring 2 to 3 centimeters * Eligible for retrograde intrarenal surgery * Normal renal function as evidenced by normal serum creatinine * Able and willing to provide written informed consent Exclusion Criteria: * Pregnancy or lactation * Active urinary tract infection at the time of enrollment * Bleeding disorders or coagulopathies that contraindicate surgical intervention * Anatomical malformations affecting the urinary tract * Solitary kidney * Inability or unwillingness to provide informed consent
| Facility | City | Country | Status |
|---|---|---|---|
| Ain Shams University Hospitals | Cairo | Egypt |