Comparison of Ultra-mini PCNL and Micro PCNL

November 15, 2019 updated by: Ozcan Kilic, Selcuk University

Comparison of Success Rates, Complication Rates and Injury to Kidneys of Ultra-mini PCNL and Micro PCNL in the Treatment of Kidney Stones

It is aimed to evaluate the treatment results, rates of success and complications, and injury given to the kidney by measuring preoperative and postoperative blood and Cystatin C levels in patients with kidney stones smaller than 2 cm who will undergo either ultra-mini percutaneous nephrolithotripsy (PCNL) or micro PCNL.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

In this study, the demographic and preoperative data, imaging data, operative data and postoperative follow-up data will be prospectively recorded according to the patient information forms for the patients with kidney stone smaller than 2 cm who will undergo either ultra-mini PCNL or micro PCNL.

A total of 60 (sixty) patients, aging between 18 and 65 years, with similar stone size and location are being planned to be enrolled into the study; and will be prospectively randomized into two groups with a 1:1 ratio, thus 30 (thirty) patients will receive ultra-mini PCNL while 30 (thirty) patients will undergo micro PCNL.

Preoperatively, blood and urine Cystatin C levels will be measured. After the surgery, blood and urine Cystatin C levels at postoperative 12th hour will be recorded. Besides these, classical kidney function tests, namely blood urea and creatinine levels, will be measured preoperatively and postoperatively.

Parameters listed below will be also recorded and evaluated:

  1. Preoperative general evaluation data: Age, height, weight, body-mass index, concomitant comorbidities, prescriptions used, history of operation(s), American Society of Anesthesiologists (ASA) score
  2. Preoperative urological evaluation data: History of extracorporeal shock wave lithotripsy (ESWL)/PCNL/ureterorenoscopy (URS)/retrograde intrarenal surgery (RIRS)/open surgery, whole blood count, kidney function tests, automatic urine test, urine culture, preoperative imaging modality (KUB, US, CT), number-dimensions-localization-composition of stone(s), existence of hydronephrosis
  3. Operative data: Access fluoroscopy duration, total access duration, total fluoroscopy duration, operation duration, use of double-J stent, preoperative complications
  4. Number of previous ESWL seance, total duration of ESWL, number of shots during ESWL (if any)
  5. Follow-up data: Urethral catheterization time, hospitalization time, need of any other treatment for being stone-free, time to full stone-free, duration to removal of double-J stent, existence of residual stone(s), formation of new stone(s), complications in late period

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
      • Konya, Turkey, 42075
        • Recruiting
        • Selcuk University, School of Medicine, Department of Urology
        • Contact:
        • Contact:

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who are planned to undergo PCNL due to kidney stone
  • Patients with a kidney stone < 2 cm
  • Patients between 18 and 65 years old

Exclusion Criteria:

  • Patients with unregulated diabetes mellitus and diabetic nephropathy
  • Patients with a blood pressure higher than 140/80 mmHg despite use of antihypertensive drug(s) regularly
  • Patients with chronic renal failure who need dialysis
  • Patients who had prerenal, renal or postrenal acute kidney failure during the last 6 months
  • Patients who had acute pyelonephritis during the last 6 months
  • Patients younger than 18 years old or older than 65 years old
  • Patients who had kidney surgery during the last 3 months and who have abnormal kidney functions
  • Patients with ureteral stone who are planned to undergo endoscopic stone treatment at the same time
  • Patients with a history of corticosteroid use during enrollment into the study or previous 3 months
  • Patients with uncontrolled thyroid disease
  • Patients who have a disease with rapid cell turn-over (like leukemia, lymphoma, etc.)
  • Patients whose operation terminated or converted to open surgery due to any reason
  • Patients with missing data

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
Active Comparator: Ultra-mini PCNL
Endoscopic kidney stone surgery: Patients will undergo ultra-mini percutaneous nephrolithotripsy.
Procedure: Endoscopic kidney stone surgery
Ultra-mini PCNL will be performed.
Procedure: Endoscopic kidney stone surgery
Micro PCNL will be performed.
Active Comparator: Micro PCNL
Endoscopic kidney stone surgery: Patients will undergo micro percutaneous nephrolithotripsy.
Procedure: Endoscopic kidney stone surgery
Ultra-mini PCNL will be performed.
Procedure: Endoscopic kidney stone surgery
Micro PCNL will be performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stone-free rate
Time Frame: Within the first 30 days after surgery.
Determination of any residual stone in the collecting system by using one of imaging modalities.
Within the first 30 days after surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complication rate
Time Frame: Within the first 30 days after surgery.
Determination of any complications related to the surgery.
Within the first 30 days after surgery.
Blood Cystatin C level (mg/L)
Time Frame: Within the first 12 hours after surgery.
Determination of any impairment in renal function after the surgery/procedure by measuring blood Cystatin C level.
Within the first 12 hours after surgery.
Urine Cystatin C level (mg/L)
Time Frame: Within the first 12 hours after surgery.
Determination of any impairment in renal function after the surgery/procedure by measuring urine Cystatin C level.
Within the first 12 hours after surgery.

Collaborators and Investigators

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

Sponsor

Selcuk University

Collaborators

The Scientific and Technological Research Council of Turkey

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)

October 8, 2019

Primary Completion (Anticipated)

July 1, 2021

Study Completion (Anticipated)

September 1, 2021

Study Registration Dates

First Submitted

August 9, 2015

First Submitted That Met QC Criteria

August 11, 2015

First Posted (Estimate)

August 13, 2015

Study Record Updates

Last Update Posted (Actual)

November 18, 2019

Last Update Submitted That Met QC Criteria

November 15, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SU-PCNL-UMMP-02

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

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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