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

NCT ID: NCT04153461

Last Updated: 2019-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-01

Study Completion Date

2021-05-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Urolithiasis Stone;Renal Nephrolithiasis PNL PCNL NEPHROLITHOTOMY MINIPERC

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

MINI-PERCUTANEOUS NEPHROLITHOTOMY

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

Group Type ACTIVE_COMPARATOR

MINI-PERCUTANEOUS NEPHROLITHOTOMY

Intervention Type PROCEDURE

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

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

Group Type ACTIVE_COMPARATOR

STANDARD PERCUTANEOUS NEPHROLITHOTOMY

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MINI-PERCUTANEOUS NEPHROLITHOTOMY

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

Intervention Type 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

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

MINIPERC MINI-PERC PNL PCNL STANDARD PNL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mansoura University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mostafa Elgamal

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Urology and Nephrology Center

Al Mansurah, Aldakahlia, Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MiniPNL

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

F-URS and Mini PCNL for Pediatric Urolithiasis
NCT06571617 NOT_YET_RECRUITING NA
Treatment of Upper Ureteric Stones
NCT02469766 UNKNOWN PHASE4
Supine Percutaneous Nephrolithotomy
NCT04869969 COMPLETED PHASE2/PHASE3
Supine Versus Prone PNL in Pediatric
NCT06012864 NOT_YET_RECRUITING NA