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

Mansoura University

Status: Unknown

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

Treatments: Procedure: STANDARD PERCUTANEOUS NEPHROLITHOTOMY; Procedure: MINI-PERCUTANEOUS NEPHROLITHOTOMY

Study type: Interventional

Funder types: Other

Identifiers

NCT04153461

MiniPNL

Details and patient eligibility

About

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.

Enrollment: 210 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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210 participants in 2 patient groups

MINI-PERCUTANEOUS NEPHROLITHOTOMY

Active Comparator group

Description:

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

Treatment:

Procedure: MINI-PERCUTANEOUS NEPHROLITHOTOMY

STANDARD PERCUTANEOUS NEPHROLITHOTOMY

Active Comparator group

Description:

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

Treatment:

Procedure: STANDARD PERCUTANEOUS NEPHROLITHOTOMY