Renal Stones
Conditions
Keywords
o Mean operative time, o Mean drop in hemoglobin, o Stone Clearance, o Fever, o Mean hospital stay
Brief summary
Renal stone disease is a common urological condition associated with significant morbidity. Percutaneous nephrolithotomy (PCNL) is the standard treatment for renal stones larger than 2 cm. Although standard PCNL (Percutaneous nephrolithotomy) is associated with high stone-free rates, it carries a risk of complications such as bleeding and prolonged hospital stay. Mini percutaneous nephrolithotomy has been introduced as a less invasive alternative with the potential to reduce morbidity. However, evidence comparing outcomes between mini-PCNL (Percutaneous nephrolithotomy) and standard PCNL (Percutaneous nephrolithotomy) remains inconsistent, particularly in the local population. This randomized controlled trial aims to compare operative and postoperative outcomes of mini-PCNL versus standard PCNL in patients with renal stones.
Detailed description
Percutaneous nephrolithotomy is the preferred surgical intervention for large renal calculi. Despite its effectiveness, standard PCNL is associated with complications including hemorrhage, postoperative pain, and prolonged hospitalization. Mini-PCNL utilizes a smaller tract size, potentially reducing parenchymal injury and blood loss while maintaining adequate stone clearance. Previous studies have reported conflicting results regarding operative time, stone-free rates, and complications between the two techniques. Additionally, limited data are available from Pakistan. This randomized controlled trial will compare operative time, hemoglobin drop, stone clearance, postoperative fever, and length of hospital stay between mini-PCNL and standard PCNL, with the aim of identifying the safer and more effective approach for renal stone management.
Interventions
PROCEDUREMini Percutaneous Nephrolithotomy
Mini-PCNL (Percutaneous nephrolithotomy) performed under general anesthesia using small-caliber tract dilation and Pneumatic lithotripsy.
Standard PCNL performed under general anesthesia using conventional tract dilation and Nephroscope-assisted stone removal.
Sponsors
Khyber Teaching Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
Eligibility Criteria Inclusion Criteria: 1. Patients aged 20 to 60 years 2. Both male and female participants 3. Single renal pelvic stone less than 30 mm in size 4. Diagnosis confirmed by intravenous urography and ultrasonography
Exclusion criteria
1. Coagulopathy (INR \> 1.5) 2. Active urinary tract infection 3. Staghorn calculus 4. Renal structural anomalies 5. Polycystic kidney disease 6. Ectopic or transplanted kidney 7. Renal malignancy 8. Uncontrolled pyonephrosis 9. Chronic renal failure or chronic liver disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Operative Time | From renal puncture to skin closure during the index surgical procedure | Duration of operative time measured in minutes from renal puncture to skin closure. |
| Stone Clearance Rate | Assessed at 1 week post-procedure. | Absence of residual stones on X-ray KUB ( Kidney, Ureter, Bladder) or ultrasonography at the time of discharge. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin Drop | Preoperqtively and 24 hours post-procedure. | Difference between preoperative and postoperative hemoglobin levels (g/dL). |
| Postoperative Fever | Post procedure up to 24 hours. | Body temperature \>101°F. |
| Length of Hospital Stay | through hospital discharge, an average of 3 days | Measured in days. |
Countries
Pakistan
Contacts
STUDY_DIRECTORDr Hazrat Ullah, MBBS, FCPS
Khyber Teaching Hospital Peshawar
Outcome results
None listed