Management of Medium Sized Renal Stones

ConditionRenal Stones
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssiut University

About this trial

Urinary stone disease is a common urological condition that affects millions of people worldwide, often leading to significant morbidity and healthcare costs. Medium-sized renal stones, typically defined as stones measuring 1 to 2 cm in diameter, pose a particular challenge in management. These stones are large enough to potentially cause significant obstruction and symptoms, yet their size and location make selecting an optimal treatment modality crucial for achieving favorable outcomes with minimal complications.

Historically, open surgery was the primary intervention for large or complex stones. However, the advent of minimally invasive techniques has revolutionized stone management, allowing for more effective and patient-friendly approaches. Among these, Super-mini percutaneous nephrolithotomy (SMP), flexible uretero-renoscopy (F-URS), and shock wave lithotripsy (SWL) have emerged as minimally invasive modalities for managing medium-sized renal stones.

This study aims to evaluate the outcomes; safety, efficacy, and complications associated with SMP versus F-URS Versus SWL in the management of reanl stones 10-20 mm in diameter.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients (≥ 18 years old)

Single renal stones 10-20 mm in longest dimension

Disqualifiers

Previous upper urinary tract exploration in ipsilateral side.

Patients with JJ stent in ipsilateral side.

Absolute contraindications to SWL

Trial design

Design model

Parallel

Treatments tested in this trial

  • Modified Tubeless Super-Mini Percutaneous Nephrolithotomy

    Procedure/Surgery

    Modified Tubeless Super-Mini Percutaneous Nephrolithotomy

  • Flexible Ureterorenoscopy

    Procedure/Surgery

    Flexible Ureterorenoscopy

  • Shockwave Lithotripsy

    Procedure/Surgery

    Shockwave Lithotripsy

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: Modified Tubeless Super-Mini Percutaneous NephrolithotomyActive comparator 1 intervention
Group B: Flexible UreterorenoscopyActive comparator 1 intervention
Group C: Shockwave LithotripsyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Stone free rate

1\. SFR (by MSCT KUB) a patient is considered stone-free if the remaining fragments are less than 3 mm in size after 3 months of the procedure

Time frame
3 months

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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