Kidney Stones, Nephrolithiasis, Renal Calculi
Conditions
Keywords
Retrograde Intrarenal Surgery, Suction-Assisted Retrograde Intrarenal Surgery, Medium-Sized Renal Stones, Stone-Free Rate, Postoperative Infection, Urosepsis, Flexible Ureteroscopy, Holmium Laser Lithotripsy, Ureteric Access Sheath, Intrarenal Pressure
Brief summary
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.
Interventions
PROCEDUREDirect In-Scope Suction
Direct 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.
PROCEDUREFlexible and Navigable Suction Ureteric Access Sheath
A 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.
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
This is an open-label surgical trial. The operating urologist cannot be masked because the two suction-assisted retrograde intrarenal surgery techniques require different instruments and procedural steps. Participants will undergo one assigned procedure according to the study protocol. Outcome assessment will be based on predefined clinical, laboratory, and imaging measures.
Intervention model description
Participants will be randomly assigned in parallel to one of two intervention arms. One arm will undergo suction-assisted retrograde intrarenal surgery using direct in-scope suction, and the other arm will undergo suction-assisted retrograde intrarenal surgery using flexible and navigable suction ureteric access sheath. Outcomes will be compared between the two groups in terms of stone-free rate, postoperative infection, operative time, intraoperative visibility, and complications.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stone-Free Rate | At 1 month after surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Infection Rate | Within 1 month after surgery | The proportion of participants who develop any postoperative infectious complications. |
| Operative Time | During surgery (Intraoperatively) | Operative time measured in minutes from ureteroscope insertion to successful placement of the double-J ureteral stent. |
| Intraoperative Visibility Score | During surgery (Intraoperatively) | 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. |
| Postoperative Complication Rate | Within 1 month after surgery | The proportion of participants with postoperative complications classified according to the Clavien-Dindo classification system. |
Countries
Egypt
Contacts
CONTACTAhmed S Marey, MBBCh
Outcome results
None listed