DISS vs FANS in Suction-Assisted RIRS for Medium-Sized Renal Stones
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorAin Shams University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Direct In-Scope Suction
Procedure/SurgeryDirect suction is applied through the working channel of the flexible ureteroscope during retrograde intrarenal surgery to facilitate evacuation of stone fragments and improve intraoperative visibility during laser lithotripsy.
Flexible and Navigable Suction Ureteric Access Sheath
Procedure/SurgeryA flexible and navigable suction ureteric access sheath is used during retrograde intrarenal surgery to provide suction-assisted evacuation of stone fragments, improve visibility, and support intrarenal pressure control during laser lithotripsy.
Treatment groups
126 Participants
are divided into 2 treatment groupsGroup A: In-Scope Suction GroupExperimental treatment 1 intervention
Group B: Flexible and Navigable Suction Ureteric Access Sheath GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Stone-Free Rate
Stone-free status will be assessed by postoperative imaging using kidney, ureter, and bladder radiography and non-contrast computed tomography. Clinically insignificant residual fragments will be defined as residual fragments measuring 2 to 3 millimeters or less.
Time frame
At 1 month after surgerySecondary outcomes
1
Postoperative Infection Rate
The proportion of participants who develop any postoperative infectious complications.
Time frame
Within 1 month after surgery2
Operative Time
Operative time measured in minutes from ureteroscope insertion to successful placement of the double-J ureteral stent.
Time frame
During surgery (Intraoperatively)3
Intraoperative Visibility Score
Intraoperative visibility will be graded by the operating surgeon using a 3-point scale: grade 0 for poor visibility, grade 1 for moderate visibility, and grade 2 for good visibility.
Time frame
During surgery (Intraoperatively)4
Postoperative Complication Rate
The proportion of participants with postoperative complications classified according to the Clavien-Dindo classification system.
Time frame
Within 1 month after surgerySponsors and contacts
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Source ClinicalTrials.gov
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