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Flexible Mini Percutaneous Nephrolithotomy Vs Retrograde Intra-renal Surgery

NCT06249100 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2024-10-29

No results posted yet for this study

Summary

The use of flexible ureteroscopy and minimally-invasive percutaneous techniques, which utilize smaller tract sizes, has been established as a way to decrease the invasiveness of procedures and improve patient outcomes compared to conventional percutaneous nephrolithotomy (PCNL) and flexible mini-PCNL has emerged as a novel technique previously first as an auxiliary procedure and then as a standalone technique. This study aims to assess the feasibility and effectiveness of flexible nephoscopy in improving stone clearance compared to standard retrograde intrarenal surgery using a flexible ureteroscope.

Conditions

  • Renal Stone

Interventions

PROCEDURE

flexible mini percutaneous nephrolithotomy

In Group A (flexible mini-PCNL cases), a puncture will be done under fluoroscopic guidance medial to the posterior axillary line using an 18-gauge puncture needle. The puncture will be directed horizontally or with a slight upward inclination towards the lower or middle calyx. After a successful puncture, a 0.035 Fr Super Stiff guidewire will be inserted. Tract dilatation with amplatz dilator followed by access sheath insertion. Stone disintegration will be done with the flexible mini-nephroscopy (WiScope Digital Endoscope System by OTU Medical, California, USA) which has a shaft length of 38 cm, distal tip diameter is 15.3 F tapering to 10 F, working channel inner diameter is 6.6 F, and the angle of deflection of the distal tip is 210 degrees.

PROCEDURE

Retrograde intrarenal surgery

n Group B, Flexible ureteroscopy will be used with a ureteral access sheath and laser fragmentation of renal stones will be done

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2024-10-01
Completion
2024-10-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06249100 on ClinicalTrials.gov