Endoscopic Guided PCNL Versus Standard PCNL

Stones, Kidney Clinical Trial

Official title:

Endoscopic Combined Intrarenal Surgery for Management of Large Renal Stones: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04825353
• Other study ID #: IDIRB2017122601-268
• Status: Recruiting
• Phase: N/A
• Start date: October 20, 2019
• Est. completion date: November 1, 2022

Study information

• Verified date: July 2022
• Source: Benha University
• Contact: Waleed El-Shaer, M.D
• Phone: 01015767331
• Email: waleed_elshaer[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: November 1, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Kidney Calculi
• Nephrolithiasis
• Stones, Kidney

Intervention

Procedure:
• Endoscopic compbined guided PCNL
patient undergo stone removal by ECIRS
• Standard PCNL
patient undergo SPCNL

Locations

Country	Name	City	State
Egypt	Banha university hospital	Banha	Qalubia

Sponsors (1)

Lead Sponsor	Collaborator
Benha University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stone Free Rate	If their is any residual stones	1day after operation.
Primary	Stone Free Rate	If their is any residual stones	1 months post operative
Primary	Stone Free Rate	If their is any residual stones	3 months post-operative
Secondary	operative time	the length of operation	intra oprative
Secondary	blood loss	hemoglobin drop	pre-operative and 1 day post-oprative