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Comparison of Ultra-mini PCNL and Micro PCNL

Primary Purpose

Kidney Stones

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Endoscopic kidney stone surgery
Endoscopic kidney stone surgery
Sponsored by
Selcuk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Stones focused on measuring kidney stone, percutaneous nephrolithotripsy, ultra-mini PCNL, micro PCNL

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Selcuk University, School of Medicine, Department of UrologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Ultra-mini PCNL

Micro PCNL

Arm Description

Endoscopic kidney stone surgery: Patients will undergo ultra-mini percutaneous nephrolithotripsy.

Endoscopic kidney stone surgery: Patients will undergo micro percutaneous nephrolithotripsy.

Outcomes

Primary Outcome Measures

Stone-free rate
Determination of any residual stone in the collecting system by using one of imaging modalities.

Secondary Outcome Measures

Complication rate
Determination of any complications related to the surgery.
Blood Cystatin C level (mg/L)
Determination of any impairment in renal function after the surgery/procedure by measuring blood Cystatin C level.
Urine Cystatin C level (mg/L)
Determination of any impairment in renal function after the surgery/procedure by measuring urine Cystatin C level.

Full Information

First Posted
August 9, 2015
Last Updated
November 15, 2019
Sponsor
Selcuk University
Collaborators
The Scientific and Technological Research Council of Turkey
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1. Study Identification

Unique Protocol Identification Number
NCT02522689
Brief Title
Comparison of Ultra-mini PCNL and Micro PCNL
Official Title
Comparison of Success Rates, Complication Rates and Injury to Kidneys of Ultra-mini PCNL and Micro PCNL in the Treatment of Kidney Stones
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 8, 2019 (Actual)
Primary Completion Date
July 2021 (Anticipated)
Study Completion Date
September 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Selcuk University
Collaborators
The Scientific and Technological Research Council of Turkey

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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: Preoperative general evaluation data: Age, height, weight, body-mass index, concomitant comorbidities, prescriptions used, history of operation(s), American Society of Anesthesiologists (ASA) score 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 Operative data: Access fluoroscopy duration, total access duration, total fluoroscopy duration, operation duration, use of double-J stent, preoperative complications Number of previous ESWL seance, total duration of ESWL, number of shots during ESWL (if any) 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Stones
Keywords
kidney stone, percutaneous nephrolithotripsy, ultra-mini PCNL, micro PCNL

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ultra-mini PCNL
Arm Type
Active Comparator
Arm Description
Endoscopic kidney stone surgery: Patients will undergo ultra-mini percutaneous nephrolithotripsy.
Arm Title
Micro PCNL
Arm Type
Active Comparator
Arm Description
Endoscopic kidney stone surgery: Patients will undergo micro percutaneous nephrolithotripsy.
Intervention Type
Procedure
Intervention Name(s)
Endoscopic kidney stone surgery
Intervention Description
Ultra-mini PCNL will be performed.
Intervention Type
Procedure
Intervention Name(s)
Endoscopic kidney stone surgery
Intervention Description
Micro PCNL will be performed.
Primary Outcome Measure Information:
Title
Stone-free rate
Description
Determination of any residual stone in the collecting system by using one of imaging modalities.
Time Frame
Within the first 30 days after surgery.
Secondary Outcome Measure Information:
Title
Complication rate
Description
Determination of any complications related to the surgery.
Time Frame
Within the first 30 days after surgery.
Title
Blood Cystatin C level (mg/L)
Description
Determination of any impairment in renal function after the surgery/procedure by measuring blood Cystatin C level.
Time Frame
Within the first 12 hours after surgery.
Title
Urine Cystatin C level (mg/L)
Description
Determination of any impairment in renal function after the surgery/procedure by measuring urine Cystatin C level.
Time Frame
Within the first 12 hours after surgery.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ozcan Kilic, M.D.
Phone
+905074196189
Email
drozcankilic@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Murat Akand, M.D.
Phone
+905327438333
Email
drmuratakand@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ozcan Kilic, M.D.
Organizational Affiliation
Selcuk University, School of Medicine, Department of Urology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Selcuk University, School of Medicine, Department of Urology
City
Konya
ZIP/Postal Code
42075
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ozcan Kilic, M.D.
Phone
+905074196189
Email
drozcankilic@yahoo.com
First Name & Middle Initial & Last Name & Degree
Murat Akand, M.D.
Phone
+905327438333
Email
drmuratakand@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
No
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Citation
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Comparison of Ultra-mini PCNL and Micro PCNL

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