Are the Stone Density and Location Useful Parameters for Small Kidney Stones?

April 19, 2018 updated by: Adnan Gucuk, Abant Izzet Baysal University

Are the Stone Density and Location Useful Parameters That Can Determine the Endourological Surgical Technique for Kidney Stones That Are Smaller Than 2 cm? Prospective Randomized Controlled Trial

The investigators aimed to evaluate whether these parameters could be guides for us in the selection of RIRS or Mini-PNL procedures in kidney stones that are smaller than 2 cm.

The patients that have kidney stones smaller than two cm and be planned to undergo surgery were randomized into 2 groups prospectively. RIRS was performed in the RIRS group using a 7.5-F fiberoptic flexible ureterorenoscope while Mini-PCNL group was dilated up to 16.5F and mini-PCNL was performed with 12F nephroscopy. Preoperative characteristics, operative and postoperative results were compared in two groups. Thereafter, intra and intergroup comparisons were made to determine the effects of HU value, indicating the stone density, higher or less than 677 and the stone location on stone-free rates.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients were evaluated with non-contrast abdominopelvic CT after a detailed anamnesis and physical examination.
  • Patients, who had a kidney stone with a maximum diameter of less than 2 cm and who did not prefer to undergo ESWL, were taken into the study.

Exclusion Criteria:

  • Patients with anomalous kidneys, skeletal deformities, severe obesity (BMI> 35) and those underwent ESWL treatment previously for the same stone were excluded from the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mini percutaneous nephrolithotomy
All operations were performed or supervised by the same surgeon. Right after the patients in mini-PNL group were placed a 5F ureteral catheter with general anesthesia, they were had a prone position and the access was performed by choosing the optimal calyx to reach the stone following the contrast agent was given. The guide wire was then placed and the stones were broken with a laser lithotripter using a 12F nephroscope (Modular minimally invasive PCNL system, Karl Storz, Tuttlingen, Germany) following the dilatation using an one step dilator with a 16.5F access sheath. When necessary, stones were removed using the stone removal forceps. Right after a 14-Fr nephrostomy tube was inserted and an antegrade pyelography was taken, the operation was terminated.
Procedure: Mini percutaneous nephrolithotomy
Active Comparator: Retrograde intrarenal surgery
Following the general anesthesia performed, a safety guide wire was placed and semirigid ureteroscopy (9.5 / 11.5F) was performed. Stones were fragmented using a 270 micron meter laser fiber with the help of 7.5-F fiber optic flexible ureterorenoscope after the placement of ureteral access sheat (9.5 / 11.5 F). Stone fragmentation was accomplished using a laser energy of 0.5-1.5 J and a rate of 5-15 Hz and adjusting this range according to stone hardness. 4.7F JJ stent was routinely placed at the end of the operation because of worries about possible edema etc. due to access sheath. In this group, access sheath could not be placed in 2 patients due to the small diameter of the ureter, and JJ stent was placed, and 2 weeks later, the procedure was performed as it was in the others.
Procedure: Retrograde intrarenal surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stone free rate
Time Frame: 1 year
Stone-free conditions were determined by low-dose spiral CT taken in postoperative third month
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean fluoroscopy time
Time Frame: İntraoperative duration of flouroscopy
İntraoperative duration of flouroscopy time
İntraoperative duration of flouroscopy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abant Izzet Baysal University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2016

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

March 28, 2018

First Submitted That Met QC Criteria

April 19, 2018

First Posted (Actual)

April 20, 2018

Study Record Updates

Last Update Posted (Actual)

April 20, 2018

Last Update Submitted That Met QC Criteria

April 19, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AbantIBU-AG001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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