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

Al-Azhar University

Status: Enrolling

Conditions: Urinary Calculi

Treatments: Procedure: Combined Intrarenal Surgery and percutaneous nephrolithotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT06519812

Urosurg./MD/2023/0008

Details and patient eligibility

About

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

Full 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,.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

• Group I (PCNL group)

Experimental group

Description:

50 patients will undergo percutaneous nephrolithotomy (PCNL).

Treatment:

Procedure: Combined Intrarenal Surgery and percutaneous nephrolithotomy

Group II (ECIRS group)

Experimental group

Description:

50 patients will undergo endoscopic combined intrarenal surgery (ECIRS).

Treatment:

Procedure: Combined Intrarenal Surgery and percutaneous nephrolithotomy