Mini- Percutaneous Nephrolithotomy Versus Standard Percutaneous Nephrolithotomy in the Treatment of Renal Stones.
1 other identifier
interventional
210
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2019
CompletedFirst Submitted
Initial submission to the registry
November 4, 2019
CompletedFirst Posted
Study publicly available on registry
November 6, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2021
CompletedNovember 13, 2019
November 1, 2019
2 years
November 4, 2019
November 10, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assessment of stone free rate (SFR)
defined as less than 4mm by non contrast computed tomography
2 years
Secondary Outcomes (4)
assessment of haemoglobin loss
2 years
assessment of pain
2 years
assessment of renal function
2 years
assessment of patient satisfaction
2 years
Study Arms (2)
MINI-PERCUTANEOUS NEPHROLITHOTOMY
ACTIVE COMPARATORMINIPERCUTANEOUS NEPHROLITHOTOMY USING NEPHROSCOPY 15 FR, LASER DUSTING OF THE STONE, NEPHROSTOMY TUBE 12 FIXATION
STANDARD PERCUTANEOUS NEPHROLITHOTOMY
ACTIVE COMPARATORPERCUTANEOUS NEPHROLITHOTOMY USING NEPHROSCOPY 24 FR, ULTRASOUND OR LITHOCLAST DISINTEGRATION OF THE STONE AND FORCEPS EXTRACTION OF THE FRAGMENTS, NEPHROSTOMY TUBE 22 FIXATION
Interventions
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- S.creatinine \> 2mg/dl.
- Patients with active UTI.
- Patients on anticoagulant.
- Age \<18 years.
- Ureteral obstruction preventing the insertion of a ureteral stent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Urology and Nephrology Center
Al Mansurah, Aldakahlia, 35516, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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
- Principal Investigator
Study Record Dates
First Submitted
November 4, 2019
First Posted
November 6, 2019
Study Start
May 1, 2019
Primary Completion
May 1, 2021
Study Completion
May 1, 2021
Last Updated
November 13, 2019
Record last verified: 2019-11
Data Sharing
- IPD Sharing
- Will not share