MINIPERC, Nephrolithiasis, NEPHROLITHOTOMY, PCNL, PNL, Stone;Renal, Urolithiasis
Conditions
Keywords
urolithiasis, stone, renal, nephrolithiasis, PNL, PCNL, NEPHROLITHOTOMY, MINIPERC, MINI-PERC, BLOOD LOSS, NEPHROSTOMY SIZE
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.
Interventions
PROCEDUREMINI-PERCUTANEOUS NEPHROLITHOTOMY
MINIPERCUTANEOUS NEPHROLITHOTOMY USING NEPHROSCOPY 15 FR, LASER DUSTING OF THE STONE, NEPHROSTOMY TUBE 12 FIXATION
PERCUTANEOUS NEPHROLITHOTOMY USING NEPHROSCOPY 24 FR, ULTRASOUND OR LITHOCLAST DISINTEGRATION OF THE STONE AND FORCEPS EXTRACTION OF THE FRAGMENTS, NEPHROSTOMY TUBE 22 FIXATION
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of stone free rate (SFR) | 2 years | defined as less than 4mm by non contrast computed tomography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| assessment of haemoglobin loss | 2 years | measured by haemoglobin change pre and postoperative (measured by grams/ deciliter) |
| assessment of pain | 2 years | measured by visual analogue scale |
| assessment of renal function | 2 years | measured by serum creatinine measured by Milligram/ deciliter |
| assessment of patient satisfaction | 2 years | measured by freiburg index of patient satisfaction |
Countries
Egypt
Outcome results
None listed