ClinicalTrials.Veeva

Menu

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

M

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)

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

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems