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Percutaneous Nephrolithotomy for Treatment of Kidney Stones Greater Than 2 cm

NCT03189264 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2017-06-16

No results posted yet for this study

Summary

Percutaneous nephrolithotomy (PCNL) is a minimally invasive procedure considered as the treatment of choice for the management of large-scale and fully-formed kidney stones.This procedure has a 5% risk of complications including bleeding, the lesion of the collecting system, the risk of urinary infection and bacteremia. New surgical tools such as dilatation of the nephrostomy tract with mechanical dilatation contribute to the reduction of these risks, together with an improvement in the operative times and a lower rate of complications.

At present there are multiple scales measuring the lithiasic morphology (Guy, the STONE nephrolitometry score system and the nomogram of the Office of Clinical Investigation of the Endourology Society - CROES) which allow to evaluate the degree of complexity of the stone, the possibility of residual stones and the risk of complications. These tools allow us to do a better analysis of the risk factors of the patient who will be taken to this type of endoscopic procedure in order to decrease morbidity and complication rates.

Hypothesis:

The use of pneumatic dilators during percutaneous nephrolithotomy reduces the rates of intraoperative and postoperative complications, which would have an impact on hospitalization times and surgical success for the management of renal stone.

Conditions

  • Renal Stone

Interventions

PROCEDURE

percutaneous nephrolithotomy for kidney stones

Use of various methods of access to the renal collecting system (pneumatic balloon dilatation vs. traditional technique with coaxial dilators) during percutaneous nephrolithotomy for treatment of kidney stones greater than 2 cm.

Sponsors & Collaborators

  • Dr Carlos Hernández

    lead OTHER

Principal Investigators

  • Carlos E Hernandez, MD · HOSPITAL UNIVERSITARIO LOS COMUNEROS

  • Andres Gutierrez, MD · HOSPITAL UNIVERSITARIO LOS COMUNEROS

  • Jose G Ramos, MD · HOSPITAL UNIVERSITARIO LOS COMUNEROS

  • Diana M Chaparro, MD · HOSPITAL UNIVERSITARIO LOS COMUNEROS

  • Eduardo Ardila, MD · HOSPITAL UNIVERSITARIO LOS COMUNEROS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-05-10
Primary Completion
2017-08-31
Completion
2017-09-30
FDA Device
Yes

Countries

  • Colombia

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 NCT03189264 on ClinicalTrials.gov