Mini- Percutaneous Nephrolithotomy Versus Standard Percutaneous Nephrolithotomy in the Treatment of Renal Stones.

Mini- Percutaneous Nephrolithotomy Versus Standard Percutaneous Nephrolithotomy in the Treatment of Renal Stones. A Randomized Controlled Trial

Sponsors

Lead Sponsor: Mansoura University

Source Mansoura University
Brief Summary

The EUA Urolithiasis Guidelines Panel meta-analysis suggest that mPNL is at least as efficacious and safe as sPNL for the removal of renal calculi. However, the quality of the evidence was poor, drawn mainly from small studies, the majority of which were single-arm case series, and only one of which was RCT. The risks of bias and confounding were high, highlighting the need for more reliable data from RCTs. So, the Panel recommended for more clinical research . The aim of this study is to compare between PNL and mPNL through a randomized controlled trial.

Overall Status Active, not recruiting
Start Date 2019-05-01
Completion Date 2021-05-01
Primary Completion Date 2021-05-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Assessment of stone free rate (SFR) 2 years
Secondary Outcome
Measure Time Frame
assessment of haemoglobin loss 2 years
assessment of pain 2 years
assessment of renal function 2 years
assessment of patient satisfaction 2 years
Enrollment 210
Condition
Intervention

Intervention Type: Procedure

Intervention Name: MINI-PERCUTANEOUS NEPHROLITHOTOMY

Description: MINIPERCUTANEOUS NEPHROLITHOTOMY USING NEPHROSCOPY 15 FR, LASER DUSTING OF THE STONE, NEPHROSTOMY TUBE 12 FIXATION

Arm Group Label: MINI-PERCUTANEOUS NEPHROLITHOTOMY

Intervention Type: Procedure

Intervention Name: STANDARD PERCUTANEOUS NEPHROLITHOTOMY

Description: PERCUTANEOUS NEPHROLITHOTOMY USING NEPHROSCOPY 24 FR, ULTRASOUND OR LITHOCLAST DISINTEGRATION OF THE STONE AND FORCEPS EXTRACTION OF THE FRAGMENTS, NEPHROSTOMY TUBE 22 FIXATION

Arm Group Label: STANDARD PERCUTANEOUS NEPHROLITHOTOMY

Eligibility

Criteria:

Inclusion Criteria: 1. Patient 18 years or older. 2. ASA I or II 3. Renal stones ≥ 2 cm 4. Lower calyceal stone ≥ 1 cm 5. Failure of other modalities of treatment as ESWL and RIRS. Exclusion Criteria: 1. S.creatinine > 2mg/dl. 2. Patients with active UTI. 3. Patients on anticoagulant. 4. Age <18 years. 5. Ureteral obstruction preventing the insertion of a ureteral stent.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Location
Facility: Urology and Nephrology Center
Location Countries

Egypt

Verification Date

2019-11-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Mansoura University

Investigator Full Name: Mostafa Elgamal

Investigator Title: Principal Investigator

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: MINI-PERCUTANEOUS NEPHROLITHOTOMY

Type: Active Comparator

Description: MINIPERCUTANEOUS NEPHROLITHOTOMY USING NEPHROSCOPY 15 FR, LASER DUSTING OF THE STONE, NEPHROSTOMY TUBE 12 FIXATION

Label: STANDARD PERCUTANEOUS NEPHROLITHOTOMY

Type: Active Comparator

Description: PERCUTANEOUS NEPHROLITHOTOMY USING NEPHROSCOPY 24 FR, ULTRASOUND OR LITHOCLAST DISINTEGRATION OF THE STONE AND FORCEPS EXTRACTION OF THE FRAGMENTS, NEPHROSTOMY TUBE 22 FIXATION

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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