Mini- Percutaneous Nephrolithotomy Versus Standard Percutaneous Nephrolithotomy in the Treatment of Renal Stones.

November 10, 2019 updated by: Mostafa Elgamal, Mansoura University

Mini- Percutaneous Nephrolithotomy Versus Standard Percutaneous Nephrolithotomy in the Treatment of Renal Stones. A Randomized Controlled Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

210

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

  • Egypt
    • Aldakahlia
      • Mansoura, Aldakahlia, Egypt, 35516
        • Urology and nephrology center

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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
Active Comparator: MINI-PERCUTANEOUS NEPHROLITHOTOMY
MINIPERCUTANEOUS NEPHROLITHOTOMY USING NEPHROSCOPY 15 FR, LASER DUSTING OF THE STONE, NEPHROSTOMY TUBE 12 FIXATION
Procedure: MINI-PERCUTANEOUS NEPHROLITHOTOMY
MINIPERCUTANEOUS NEPHROLITHOTOMY USING NEPHROSCOPY 15 FR, LASER DUSTING OF THE STONE, NEPHROSTOMY TUBE 12 FIXATION
Other Names:
  • MINIPERC
  • MINI-PERC
Active Comparator: STANDARD PERCUTANEOUS NEPHROLITHOTOMY
PERCUTANEOUS NEPHROLITHOTOMY USING NEPHROSCOPY 24 FR, ULTRASOUND OR LITHOCLAST DISINTEGRATION OF THE STONE AND FORCEPS EXTRACTION OF THE FRAGMENTS, NEPHROSTOMY TUBE 22 FIXATION
Procedure: STANDARD PERCUTANEOUS NEPHROLITHOTOMY
PERCUTANEOUS NEPHROLITHOTOMY USING NEPHROSCOPY 24 FR, ULTRASOUND OR LITHOCLAST DISINTEGRATION OF THE STONE AND FORCEPS EXTRACTION OF THE FRAGMENTS, NEPHROSTOMY TUBE 22 FIXATION
Other Names:
  • PCNL
  • PNL
  • STANDARD PNL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of stone free rate (SFR)
Time Frame: 2 years
defined as less than 4mm by non contrast computed tomography
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
assessment of haemoglobin loss
Time Frame: 2 years
measured by haemoglobin change pre and postoperative (measured by grams/ deciliter)
2 years
assessment of pain
Time Frame: 2 years
measured by visual analogue scale
2 years
assessment of renal function
Time Frame: 2 years
measured by serum creatinine measured by Milligram/ deciliter
2 years
assessment of patient satisfaction
Time Frame: 2 years
measured by freiburg index of patient satisfaction
2 years

Collaborators and Investigators

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

Sponsor

Mansoura University

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)

May 1, 2019

Primary Completion (Anticipated)

May 1, 2021

Study Completion (Anticipated)

May 1, 2021

Study Registration Dates

First Submitted

November 4, 2019

First Submitted That Met QC Criteria

November 4, 2019

First Posted (Actual)

November 6, 2019

Study Record Updates

Last Update Posted (Actual)

November 13, 2019

Last Update Submitted That Met QC Criteria

November 10, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MiniPNL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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