Endoscopic Guided PCNL Versus Standard PCNL

Benha University

Status: Enrolling

Conditions: Stones, Kidney

Treatments: Procedure: Standard PCNL; Procedure: Endoscopic compbined guided PCNL

Study type: Interventional

Funder types: Other

Identifiers

NCT04825353

IDIRB2017122601-268

Details and patient eligibility

About

currently, percutaneous nephrolithotomy (PCNL) is the standard procedure of choice for management of large renal more than 2 cm.

the pivotal step in performing PCNL is creation of proper tract. this step can be done monitored under guidance of different modalities such as fluoroscopy, ultrasonography, endoscopy or combined in ECIRS, tract creation is controlled under endoscopic vision with a flexible ureteroscope .

Full description

Aim: compare safety and efficacy and adverse events of ECIRS in comparison of standard fluoroscopic guided PCNL.

patients & methods: Patients will randomly be divided into two equal groups:

Group A: Patient will undergo ECIRS.

Group B: Patient will undergo standard PCNL

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with renal stones diameter of at least 2 cm.
• American Society of Anesthesiology score ≤ 2.

Exclusion criteria

• patients with renal anomalies.
• transplanted kidney.
• uncorrected coagulopathy.
• active infection.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 2 patient groups

ECIRS-Group

Experimental group

Treatment:

Procedure: Endoscopic compbined guided PCNL

SPCNL-GRoup

Active Comparator group

Treatment:

Procedure: Standard PCNL