Endoscopic Guided PCNL Versus Standard PCNL

Not Applicable

• Conditions: Stones, Kidney

• Registration Number: NCT04825353
• Lead Sponsor: Benha University

Brief Summary

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 .

Detailed 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

Study Timeline

• Study Start: 2019-10-20
• Study First Submitted: 2021-03-25
• Study First Submitted QC: 2021-03-30
• Study First Posted: 2021-04-01
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-17
• Last Update Posted: 2022-07-19
• Primary Completion: 2022-10-01
• Study Completion: 2022-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Stone Free Rate	3 months post-operative	If their is any residual stones

Secondary Outcome Measures

Name	Time	Method
operative time	intra oprative	the length of operation
blood loss	pre-operative and 1 day post-oprative	hemoglobin drop

Trial Locations

Locations (1)

Banha university hospital; 🇪🇬 Banhā, Qalubia, Egypt