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

Not Applicable

• Conditions: Nephrolithiasis; Urolithiasis; Stone;Renal; PCNL; NEPHROLITHOTOMY; PNL; MINIPERC

• Registration Number: NCT04153461
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-01
• Status Verified: 2019-11
• Study First Submitted: 2019-11-04
• Study First Submitted QC: 2019-11-04
• Study First Posted: 2019-11-06
• Last Update Submitted: 2019-11-10
• Last Update Posted: 2019-11-13
• Primary Completion: 2021-05-01
• Study Completion: 2021-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 210

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Assessment of stone free rate (SFR)	2 years	defined as less than 4mm by non contrast computed tomography

Secondary Outcome Measures

Name	Time	Method
assessment of pain	2 years	measured by visual analogue scale
assessment of patient satisfaction	2 years	measured by freiburg index of patient satisfaction
assessment of haemoglobin loss	2 years	measured by haemoglobin change pre and postoperative (measured by grams/ deciliter)
assessment of renal function	2 years	measured by serum creatinine measured by Milligram/ deciliter

Trial Locations

Locations (1)

Urology and Nephrology Center; 🇪🇬 Mansoura, Aldakahlia, Egypt