Flexible single-tract nephroscopy vs. multi-tract PCNL for complex kidney stones

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with complex unilateral renal stones are randomized to receive either flexible nephroscopy-assisted single-tract PCNL or conventional multi-tract PCNL. The study’s primary goal is to see if the single-tract approach is not worse than the multi-tract approach in achieving a stone-free kidney at 3 months. Secondary outcomes assess operative and fluoroscopy times, blood loss, transfusion needs, length of hospital stay, complications, need for additional procedures, and cost-effectiveness. The analysis will also explore how predictive stone scoring systems relate to outcomes. This is a prospective, parallel-group, non-inferiority trial.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 18-70 years.

Unilateral complex renal stones defined by one or more of the following: Guy's Stone Score III-IV, S.T.O.N.E. score ≥9, staghorn or partial staghorn calculus, or stones involving at least 3 calyces on NCCT.

Preoperative expectation of multiple accesses by the surgeon.

Written informed consent.

Exclusion Criteria:

Solitary kidney.

Uncorrected coagulopathy.

Active urinary tract infection.

ASA grade IV or higher.

Pregnancy.

Previous ipsilateral PCNL or open renal surgery.

Stones less than 2 cm or simple calyceal stones.

Refusal or inability to comply with follow-up.

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Where it's running

• Department of Urology, Al-Hussein and Sayed Galal University Hospitals, Al-Azhar University
  Cairo, Egypt Recruiting

Study contacts

• Principal investigator: Abul-fotouh Ahmed — Department of Urology, Faculty of Medicine, Al-Azhar University, Cairo, Egypt
• Study coordinator: Abul-fotouh Ahmed
• Email: abulfotouhahmed7070@gmail.com
• Phone: 00201001066756

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.