NCT Number: NCT07753733
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.
Interested in participating?
Request Info18 year–70 year
All sexes
Interventional
Not applicable
Cairo, Egypt
Location status: Recruiting
Abul-fotouh Ahmed
CONTACT
Ahmed S Elasy
SUB_INVESTIGATOR
Hassan Ismail, MD
SUB_INVESTIGATOR
Mohammed Abdelkhalik, MD
SUB_INVESTIGATOR
Mohammed Elgammal, MD
SUB_INVESTIGATOR
This prospective randomized non-inferiority trial will enroll adults aged 18-70 years with complex unilateral renal stones anticipated to require multiple accesses. Participants will be randomized in a 1:1 ratio to either flexible nephroscopy-assisted single-tract PCNL or conventional multi-tract PCNL. The study aims to determine whether the single-tract approach is not inferior to the multi-tract approach with respect to stone-free rate at 3 months, while potentially reducing perioperative morbidity, including bleeding, transfusion, operative time, and length of hospital stay. Secondary analyses will evaluate complication profiles using Clavien-Dindo classification, need for auxiliary procedures, cost-effectiveness, and the predictive value of Guy's Stone Score and S.T.O.N.E. score.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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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Single-tract percutaneous nephrolithotomy using flexible nephroscopy through the same tract, with rigid nephroscopy, pneumatic lithotripsy, and Holmium:YAG laser as needed.
Multi-tract percutaneous nephrolithotomy using rigid nephroscopy through multiple accesses, with pneumatic lithotripsy as needed.
Time frame: 3 months after surgery.
Proportion of patients with no residual stone fragments greater than 4 mm on non-contrast CT.
Time frame: Intraoperative
Time from skin incision or anesthesia induction to completion of the procedure.
Time frame: Intraoperative
Total duration of fluoroscopy exposure during the procedure.
Time frame: Intraoperative
Total number of percutaneous renal access tracts used to complete stone clearance.
Time frame: From baseline to postoperative day 1.
Difference between preoperative hemoglobin and postoperative day 1 hemoglobin.
Time frame: Perioperative/Periprocedural
Proportion of patients requiring blood transfusion after surgery.
Time frame: From the date of PCNL surgery until hospital discharge.
Duration of postoperative hospitalization will be calculated as the number of days from the date of PCNL surgery until the date of hospital discharge. The date of surgery will be counted as Day 0. The reason for prolonged hospitalization, when applicable, will be documented.
Time frame: Up to 3 months
Postoperative complications classified according to the Clavien-Dindo grading system.
Contact information is provided by the study sponsor or research team.
Al-Azhar University
Other
Flexible Nephroscopy-Assisted Single-Tract Versus Multi-Tract Percutaneous Nephrolithotomy for Complex Renal Stones: A Prospective, Randomized, Non-Inferiority Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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