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Endoscopic Combined Intrarenal Surgery Versus Multi-Tract Percutaneous Nephrolithotomy for Complex Renal Stones:

NCT05460559 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2022-11-14

No results posted yet for this study

Summary

The aim of this study is to compare outcomes of endoscopic combined intrarenal surgery (ECIRS) with the multi-tract percutaneous nephrolithotomy for management of complex renal stones.

Conditions

  • Stone, Kidney

Interventions

PROCEDURE

Group A (p-PCNL) procedure

In lithotomy position, ureteric catheter will be inserted allowing injection of contrast to obtain a pyelogram. Shifting the patients in prone position will be done. Under fluoroscopic guidance, the desired calyces will be punctured using an 18 G coaxial needle. Then 0.038 mm hydrophilic guidewires will be passed percutaneously through the needle into the pelvis. Using metal dilators dilatation will be carried out. Amplatz sheath will be inserted to allow nephroscope to enter the collecting system. Stone disintegration will be performed using pneumatic, ultrasonic or laser lithotripsy. Eventually after removal of all stone fragments, a nephrostomy tube will be placed.

PROCEDURE

Group B (s-ECIRS) procedure

The patients will be in Galdakao-Modified Supine Valdivia (GMSV) position . Under fluoroscopic guidance, the desired calyces will be punctured using an 18 G coaxial needle. Then 0.038 mm hydrophilic guidewires will be passed percutaneously through the needle into the pelvis. Using metal dilators dilatation will be carried out till 30 Fr. Amplatz sheath will be inserted to allow a 26 Fr nephroscope to enter the collecting system. Retrograde intrarenal surgery will be applied simultaneously by a second surgeon using flexible ureteroscopy. The stones will be fragmented with holmium-yttrium-aluminum-garnet (YAG) laser and stone fragments will be evacuated by basket or removed through PCNL tract under nephroscopy.

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Principal Investigators

  • Ahmed A El-Nahas · Mansoura University

  • Ahmed A Elshal · Mansoura University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-01
Primary Completion
2023-12-01
Completion
2024-01-01

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 NCT05460559 on ClinicalTrials.gov