Comparison of Ultra-mini PCNL and Micro PCNL

Sponsor

Selcuk University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02522689

Collaborator

The Scientific and Technological Research Council of Turkey (Other)

Enrollment

Location

Arms

22.8

Anticipated Duration (Months)

2.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Stones	Procedure: Endoscopic kidney stone surgery Procedure: Endoscopic kidney stone surgery	N/A

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Oct 8, 2019

Anticipated Primary Completion Date :

Jul 1, 2021

Anticipated Study Completion Date :

Sep 1, 2021

Arms and Interventions

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

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.

Active Comparator: Micro PCNL

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

Procedure: Endoscopic kidney stone surgery

Micro PCNL will be performed.

Outcome Measures

Primary Outcome Measures

Stone-free rate [Within the first 30 days after surgery.]
Determination of any residual stone in the collecting system by using one of imaging modalities.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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