Endoscopic Combined Intrarenal Surgery vs. Percutaneous Nephrolithotomy for Treatment of Staghorn Calculi

Not Applicable

Recruiting

• Conditions: Urinary Calculi
• Interventions: Procedure: Combined Intrarenal Surgery and percutaneous nephrolithotomy

• Registration Number: NCT06519812
• Lead Sponsor: Al-Azhar University

Brief Summary

This is a prospective randomized study to compare endoscopic combined intrarenal surgery and PCNL as modalities of treatment for staghorn stones. In terms of efficacy and safety

Detailed Description

This is a prospective randomized study to compare endoscopic combined intrarenal surgery and PCNL as modalities of treatment for staghorn stones. In terms of efficacy and safety The efficacy will be studied at stone-free rate While efficacy will be studied using DMSA scan pre- and post-procedures in addition to the safety of each procedure with regard to intra- and post-operative complications,.

Study Timeline

• Study Start: 2023-07-01
• Study First Submitted: 2024-06-27
• Status Verified: 2024-07
• Study First Submitted QC: 2024-07-20
• Last Update Submitted: 2024-07-20
• Study First Posted: 2024-07-25
• Last Update Posted: 2024-07-25
• Primary Completion: 2024-12-01
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients are more than 18 and less than 65 years old.
• Patients with renal staghorn stones based on imaging modalities (stones occupying the renal pelvis and extending into at least 2 major calyces).

Exclusion Criteria

• Patients with renal insufficiency (serum creatinine > 1.6 mg/dl)
• patients with active urinary tract infection.
• Patients with congenital renal anomalies.
• Morbid obesity (BMI > 35 kg/m2).
• Pregnancy.
• Bleeding Coagulopathy.
• Skeletal deformity

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group II (ECIRS group)	Combined Intrarenal Surgery and percutaneous nephrolithotomy	50 patients will undergo endoscopic combined intrarenal surgery (ECIRS).
• Group I (PCNL group)	Combined Intrarenal Surgery and percutaneous nephrolithotomy	50 patients will undergo percutaneous nephrolithotomy (PCNL).

Primary Outcome Measures

Name	Time	Method
stone-free rate	3 months postoperative	Stone-free is defined as no residual stones on CT-UT or clinically insignificant residual fragments (CIRF) less than 4 mm in diameter.; It will be measured twice, first immediately postoperatively, and then again after 3 months of the procedure.

Secondary Outcome Measures

Name	Time	Method
Safety of the procedure	intraoperative, early (in the first day postoperative) and late complications (3 months after the surgery).	Intra and post-operative complications

Trial Locations

Locations (1)

Al-Azhar University Hospital (New Damietta); 🇪🇬 Damietta, Egypt