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Flexible Nephroscopy-Assisted Single-Tract Versus Multi-Tract Percutaneous Nephrolithotomy for Complex Renal Stones

ConditionPercutaneous Nephrolithotomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorAl-Azhar University

About this trial

This randomized, parallel-group, non-inferiority trial will compare flexible nephroscopy-assisted single-tract percutaneous nephrolithotomy with conventional multi-tract percutaneous nephrolithotomy in patients with complex unilateral renal stones. The primary outcome is stone-free rate at 3 months, and secondary outcomes include operative time, fluoroscopy time, hemoglobin drop, transfusion rate, hospital stay, complications, need for auxiliary procedures, and cost-effectiveness.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-70 years.

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Flexible Nephroscopy-Assisted Single-Tract PCNL

    Procedure/Surgery

    Single-tract percutaneous nephrolithotomy using flexible nephroscopy through the same tract, with rigid nephroscopy, pneumatic lithotripsy, and Holmium:YAG laser as needed.

  • Conventional Multi-Tract PCNL

    Procedure/Surgery

    Multi-tract percutaneous nephrolithotomy using rigid nephroscopy through multiple accesses, with pneumatic lithotripsy as needed.

Treatment groups

470 Participants
are divided into 2 treatment groups
Group A: Flexible Nephroscopy-Assisted Single-Tract PCNLExperimental treatment 1 intervention
Group B: Conventional Multi-Tract PCNLExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Stone-free rate at 3 months.

Proportion of patients with no residual stone fragments greater than 4 mm on non-contrast CT.

Time frame
3 months after surgery.

Secondary outcomes

1

Operative time

Time from skin incision or anesthesia induction to completion of the procedure.

Time frame
Intraoperative
2

Fluoroscopy time

Total duration of fluoroscopy exposure during the procedure.

Time frame
Intraoperative
3

Number of tracts

Total number of percutaneous renal access tracts used to complete stone clearance.

Time frame
Intraoperative
4

Hemoglobin drop

Difference between preoperative hemoglobin and postoperative day 1 hemoglobin.

Time frame
From baseline to postoperative day 1.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Al-Azhar University

Lead sponsor

Source ClinicalTrials.gov
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