Standard Versus Mini Percutaneous Nephrolithotomy for Renal Stones

March 6, 2026 updated by: Dr Murad Ali, Khyber Teaching Hospital

Comparison of the Outcome of Mini-Percutaneous Nephrolithotomy Versus Standard Percutaneous Nephrolithotomy in 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • KhyberPakhtunkhwa
      • Peshawar, KhyberPakhtunkhwa, Pakistan, 25000
        • Khyber Teaching Hospital Peshawar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mini Percutaneous Nephrolithotomy
Patients will undergo Mini Percutaneous Nephrolithotomy using an 11-13 Fr Amplatz sheath and Semi-rigid Ureteroscope for stone fragmentation and removal.
Procedure: Mini Percutaneous Nephrolithotomy
Mini-PCNL (Percutaneous nephrolithotomy) performed under general anesthesia using small-caliber tract dilation and Pneumatic lithotripsy.
Active Comparator: Standard Percutaneous Nephrolithotomy
Patients will undergo Standard Percutaneous Nephrolithotomy using a 30 Fr Amplatz sheath and Standard Nephroscope.
Procedure: Standard Percutaneous Nephrolithotomy
Standard PCNL performed under general anesthesia using conventional tract dilation and Nephroscope-assisted stone removal.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From renal puncture to skin closure during the index surgical procedure
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.
Assessed at 1 week post-procedure.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin Drop
Time Frame: Preoperqtively and 24 hours post-procedure.
Difference between preoperative and postoperative hemoglobin levels (g/dL).
Preoperqtively and 24 hours post-procedure.
Postoperative Fever
Time Frame: Post procedure up to 24 hours.
Body temperature >101°F.
Post procedure up to 24 hours.
Length of Hospital Stay
Time Frame: through hospital discharge, an average of 3 days
Measured in days.
through hospital discharge, an average of 3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Khyber Teaching Hospital

Investigators

  • Study Director: Dr Hazrat Ullah, MBBS, FCPS, Khyber Teaching Hospital Peshawar

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 16, 2025

Primary Completion (Actual)

December 31, 2025

Study Completion (Actual)

December 31, 2025

Study Registration Dates

First Submitted

January 13, 2026

First Submitted That Met QC Criteria

March 6, 2026

First Posted (Actual)

March 11, 2026

Study Record Updates

Last Update Posted (Actual)

March 11, 2026

Last Update Submitted That Met QC Criteria

March 6, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KMC-IREB-547

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Data sharing plans have not been finalized . However, Individual participant data might not be shared due to institutional policy and absence of a formal data-sharing framework. But this will depend on journal requirements, funding agency policies.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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