NCT07464717

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 16, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

January 13, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 11, 2026

Completed
Last Updated

March 11, 2026

Status Verified

March 1, 2026

Enrollment Period

5 months

First QC Date

January 13, 2026

Last Update Submit

March 6, 2026

Conditions

Renal Stones

Keywords

o Mean operative timeo Mean drop in hemoglobino Stone Clearanceo Fevero Mean hospital stay

Outcome Measures

Primary Outcomes (2)

  • Operative Time

    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

    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 Outcomes (3)

  • Hemoglobin Drop

    Preoperqtively and 24 hours post-procedure.

  • Postoperative Fever

    Post procedure up to 24 hours.

  • Length of Hospital Stay

    through hospital discharge, an average of 3 days

Study Arms (2)

Mini Percutaneous Nephrolithotomy

EXPERIMENTAL

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

Standard Percutaneous Nephrolithotomy

ACTIVE COMPARATOR

Patients will undergo Standard Percutaneous Nephrolithotomy using a 30 Fr Amplatz sheath and Standard Nephroscope.

Procedure: Standard Percutaneous Nephrolithotomy

Interventions

Mini Percutaneous NephrolithotomyPROCEDURE

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

Mini Percutaneous Nephrolithotomy
Standard Percutaneous NephrolithotomyPROCEDURE

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

Standard Percutaneous Nephrolithotomy

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Khyber Teaching Hospital Peshawar

Peshawar, KhyberPakhtunkhwa, 25000, Pakistan

Location

MeSH Terms

Conditions

Nephrolithiasis

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisMale Urogenital Diseases

Study Officials

  • Dr Hazrat Ullah, MBBS, FCPS

    Khyber Teaching Hospital Peshawar

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Urologist, Department of Urology

Study Record Dates

First Submitted

January 13, 2026

First Posted

March 11, 2026

Study Start

August 16, 2025

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

March 11, 2026

Record last verified: 2026-03

Locations

PA(1)