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

Primary Purpose

Urolithiasis, Stone;Renal, Nephrolithiasis

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
MINI-PERCUTANEOUS NEPHROLITHOTOMY
STANDARD PERCUTANEOUS NEPHROLITHOTOMY
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urolithiasis focused on measuring urolithiasis, stone, renal, nephrolithiasis, PNL, PCNL, NEPHROLITHOTOMY, MINIPERC, MINI-PERC, BLOOD LOSS, NEPHROSTOMY SIZE

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Urology and Nephrology Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

MINI-PERCUTANEOUS NEPHROLITHOTOMY

STANDARD PERCUTANEOUS NEPHROLITHOTOMY

Arm Description

MINIPERCUTANEOUS NEPHROLITHOTOMY USING NEPHROSCOPY 15 FR, LASER DUSTING OF THE STONE, NEPHROSTOMY TUBE 12 FIXATION

PERCUTANEOUS NEPHROLITHOTOMY USING NEPHROSCOPY 24 FR, ULTRASOUND OR LITHOCLAST DISINTEGRATION OF THE STONE AND FORCEPS EXTRACTION OF THE FRAGMENTS, NEPHROSTOMY TUBE 22 FIXATION

Outcomes

Primary Outcome Measures

Assessment of stone free rate (SFR)
defined as less than 4mm by non contrast computed tomography

Secondary Outcome Measures

assessment of haemoglobin loss
measured by haemoglobin change pre and postoperative (measured by grams/ deciliter)
assessment of pain
measured by visual analogue scale
assessment of renal function
measured by serum creatinine measured by Milligram/ deciliter
assessment of patient satisfaction
measured by freiburg index of patient satisfaction

Full Information

First Posted
November 4, 2019
Last Updated
November 10, 2019
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT04153461
Brief Title
Mini- Percutaneous Nephrolithotomy Versus Standard Percutaneous Nephrolithotomy in the Treatment of Renal Stones.
Official Title
Mini- Percutaneous Nephrolithotomy Versus Standard Percutaneous Nephrolithotomy in the Treatment of Renal Stones. A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
May 1, 2021 (Anticipated)
Study Completion Date
May 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urolithiasis, Stone;Renal, Nephrolithiasis, PNL, PCNL, NEPHROLITHOTOMY, MINIPERC
Keywords
urolithiasis, stone, renal, nephrolithiasis, PNL, PCNL, NEPHROLITHOTOMY, MINIPERC, MINI-PERC, BLOOD LOSS, NEPHROSTOMY SIZE

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
210 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MINI-PERCUTANEOUS NEPHROLITHOTOMY
Arm Type
Active Comparator
Arm Description
MINIPERCUTANEOUS NEPHROLITHOTOMY USING NEPHROSCOPY 15 FR, LASER DUSTING OF THE STONE, NEPHROSTOMY TUBE 12 FIXATION
Arm Title
STANDARD PERCUTANEOUS NEPHROLITHOTOMY
Arm Type
Active Comparator
Arm Description
PERCUTANEOUS NEPHROLITHOTOMY USING NEPHROSCOPY 24 FR, ULTRASOUND OR LITHOCLAST DISINTEGRATION OF THE STONE AND FORCEPS EXTRACTION OF THE FRAGMENTS, NEPHROSTOMY TUBE 22 FIXATION
Intervention Type
Procedure
Intervention Name(s)
MINI-PERCUTANEOUS NEPHROLITHOTOMY
Other Intervention Name(s)
MINIPERC, MINI-PERC
Intervention Description
MINIPERCUTANEOUS NEPHROLITHOTOMY USING NEPHROSCOPY 15 FR, LASER DUSTING OF THE STONE, NEPHROSTOMY TUBE 12 FIXATION
Intervention Type
Procedure
Intervention Name(s)
STANDARD PERCUTANEOUS NEPHROLITHOTOMY
Other Intervention Name(s)
PNL, PCNL, STANDARD PNL
Intervention Description
PERCUTANEOUS NEPHROLITHOTOMY USING NEPHROSCOPY 24 FR, ULTRASOUND OR LITHOCLAST DISINTEGRATION OF THE STONE AND FORCEPS EXTRACTION OF THE FRAGMENTS, NEPHROSTOMY TUBE 22 FIXATION
Primary Outcome Measure Information:
Title
Assessment of stone free rate (SFR)
Description
defined as less than 4mm by non contrast computed tomography
Time Frame
2 years
Secondary Outcome Measure Information:
Title
assessment of haemoglobin loss
Description
measured by haemoglobin change pre and postoperative (measured by grams/ deciliter)
Time Frame
2 years
Title
assessment of pain
Description
measured by visual analogue scale
Time Frame
2 years
Title
assessment of renal function
Description
measured by serum creatinine measured by Milligram/ deciliter
Time Frame
2 years
Title
assessment of patient satisfaction
Description
measured by freiburg index of patient satisfaction
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient 18 years or older. ASA I or II Renal stones ≥ 2 cm Lower calyceal stone ≥ 1 cm Failure of other modalities of treatment as ESWL and RIRS. Exclusion Criteria: S.creatinine > 2mg/dl. Patients with active UTI. Patients on anticoagulant. Age <18 years. Ureteral obstruction preventing the insertion of a ureteral stent.
Facility Information:
Facility Name
Urology and Nephrology Center
City
Mansoura
State/Province
Aldakahlia
ZIP/Postal Code
35516
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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