FANS VS DISS in Treatment of Renal Stone < 2cm
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Flexible ureteroscopy.
- Who it may be relevant to
- Registry conditions: Renal Calculi. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Flexible and Navigable Access Sheath (FANS) VS Direct in Scope Suction (DISS) in Treatment of Renal Stone > 2 cm , Controlled Randomized Trial
Overview
To compare between FANS \& DISS in : * Operative time * Stone free rate * Complications * Amount of fluid irrigation
Detailed description
Retrograde intrarenal surgery (RIRS) has revolutionized the management of renal stones, yet achieving high stone-free rates (SFR) while maintaining low intrarenal pressure (IRP) remains a challenge. Elevated IRP during irrigation is linked to post-operative complications, including systemic inflammatory response syndrome and renal parenchymal damage. To mitigate these risks, suction-assisted technologies have emerged as vital adjuncts to traditional flexible ureteroscopy (FURS).The Flexible and Navigable Access Sheath (FANS) represents a significant evolution in this field. Unlike traditional rigid sheaths, FANS features a deflectable tip that can be guided into specific calyces, allowing for synchronized suction and active fragment evacuation. Conversely, Direct In-Scope Suction (DISS) utilizes a sheathless approach, where suction is integrated directly into the ureteroscope. While DISS avoids potential ureteral trauma associated with access sheaths, FANS is often associated with shorter operative times due to its superior irrigation-aspiration efficiency.For renal stones measuring less than 2 cm, both techniques aim to optimize the "perfusion-absorption" balance, effectively clearing stone dust and debris while preventing pyelovenous reflux. However, comparative data specifically for smaller stones remains limited. This study evaluates the clinical efficacy, safety profiles, and operative outcomes of FANS versus DISS in the treatment of renal calculi \< 2 cm, aiming to determine which suction modality provides the most favorable balance of procedural efficiency and patient safety.
Interventions
- Procedure Flexible ureteroscopy
Unlike traditional rigid sheaths, FANS features a deflectable tip that can be guided into specific calyces, allowing for synchronized suction and active fragment evacuation. Conversely, Direct In-Scope Suction (DISS) utilizes a sheathless approach, where suction is integrated directly into the ureteroscope. While DISS avoids potential ureteral trauma associated with access sheaths, FANS is often associated with shorter operative times due to its superior irrigation-aspiration efficiency
Primary outcome measures
- Operative time [Time frame: <60 minutes]
Eligibility criteria
Inclusion criteria
- All patients < 18 years old presented with renal stone > 2cm whatever the site of the stone (pelvic or calyceal)
Exclusion criteria
- Inaccessibility to introduce access sheath or FURS
- Previous Inserted JJ stent
- Active UTI
- Patients refuse to participate in the protocol
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07559214 · FANS VS DISS