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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAl-Azhar University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Combined Intrarenal Surgery and percutaneous nephrolithotomy

    Procedure/Surgery

    A study was conducted to compare endoscopic combined intrarenal surgery and percutaneous nephrolithotomy as modalities of treatment for staghorn stones.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: • Group I (PCNL group)Experimental treatment 1 intervention
Group B: Group II (ECIRS group)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

stone-free rate

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.

Time frame
3 months postoperative

Secondary outcomes

1

Safety of the procedure

Intra and post-operative complications

Time frame
intraoperative, early (in the first day postoperative) and late complications (3 months after the surgery).

Other outcomes

Sponsors and contacts

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