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Completed

NCT Number: NCT07464717

Standard Versus Mini Percutaneous Nephrolithotomy for Renal Stones

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.

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Key information

Conditions

Renal Stones Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Nephrolithiasis Urogenital Diseases Urolithiasis Urologic Diseases

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Khyber Teaching Hospital Peshawar

Peshawar, KhyberPakhtunkhwa, 25000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Eligibility Criteria

Inclusion criteria

  • Patients aged 20 to 60 years
  • Both male and female participants
  • Single renal pelvic stone less than 30 mm in size
  • Diagnosis confirmed by intravenous urography and ultrasonography

Exclusion criteria

  • Coagulopathy (INR > 1.5)
  • Active urinary tract infection
  • Staghorn calculus
  • Renal structural anomalies
  • Polycystic kidney disease
  • Ectopic or transplanted kidney
  • Renal malignancy
  • Uncontrolled pyonephrosis
  • Chronic renal failure or chronic liver disease

Treatment and study plan

Mini Percutaneous Nephrolithotomy

Procedure

Mini-PCNL (Percutaneous nephrolithotomy) performed under general anesthesia using small-caliber tract dilation and Pneumatic lithotripsy.

Standard percutaneous nephrolithotomy

Procedure

Standard PCNL performed under general anesthesia using conventional tract dilation and Nephroscope-assisted stone removal.

Primary outcomes

  1. Operative Time

    Time frame: From renal puncture to skin closure during the index surgical procedure

    Duration of operative time measured in minutes from renal puncture to skin closure.

  2. Stone Clearance Rate

    Time frame: 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 outcomes

  1. Hemoglobin Drop

    Time frame: Preoperqtively and 24 hours post-procedure.

    Difference between preoperative and postoperative hemoglobin levels (g/dL).

  2. Postoperative Fever

    Time frame: Post procedure up to 24 hours.

    Body temperature >101°F.

  3. Length of Hospital Stay

    Time frame: through hospital discharge, an average of 3 days

    Measured in days.

Sponsors and collaborators

Lead sponsor

Khyber Teaching Hospital

Other

Registry information

Official study title

Comparison of the Outcome of Mini-Percutaneous Nephrolithotomy Versus Standard Percutaneous Nephrolithotomy in Renal Stones

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 11, 2026
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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