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A Prospective Comparison of Fluoroscopic, Sonographic or Combined Approach for Renal Access in Percutaneous Nephrolithotomy

NCT02266381 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2016-11-09

Study results available
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Summary

Purpose:

The aim of this present study is to compare the result of fluoroscopy, ultrasonography (US) and US combined with fluoroscopy in the guidance of minimally invasive percutaneous nephrolithotomy (MPCNL).

Methods:

The investigators will enroll 450 patients who are candidates for MPCNL in our study. By simple random sampling technique, patients will be assigned to three 150-patient groups (group 1, US-guided MPCNL, group 2, fluoroscopy-guided MPCNL and group 3, US combined with fluoroscopy-guided MPCNL). In addition to approaches in guidance of MPCNL, the rest of the procedure is the same in all three groups.The end point of the study is the comparison of outcome of procedure including stone free rate, transfusion rate, operation time, access time, length of stay and complications.

Conditions

  • Urolithiasis

Interventions

PROCEDURE

US-guided renal access

Patients undergo MPCNL using only US-guided renal access.

PROCEDURE

Fluoroscopy-guided renal access

Patients undergo MPCNL using only fluoroscopy-guided renal access.

PROCEDURE

US combined with fluoroscopy-guided renal access

Patients undergo MPCNL using US combined with fluoroscopy-guided renal access

Sponsors & Collaborators

  • The First Affiliated Hospital of Guangzhou Medical University

    lead OTHER

Principal Investigators

  • Guohua Zeng, PH.D and M.D · The First Affiliated Hospital of Guangzhou Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • China

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 NCT02266381 on ClinicalTrials.gov