Comparing two surgical methods for treating large kidney stones
Efficacy and Safety of Endoscopic Combined Intrarenal Surgery vs. Percutaneous Nephrolithotomy for Treatment of Staghorn Calculi, A Prospective Randomized Study
This study is testing which of two surgical methods is better and safer for people with large kidney stones.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Al-Azhar University Academic / other |
| Locations | 1 site (Damietta) |
| Trial ID | NCT06519812 on ClinicalTrials.gov |
What this trial studies
This prospective randomized study aims to compare the efficacy and safety of endoscopic combined intrarenal surgery and percutaneous nephrolithotomy (PCNL) in treating staghorn stones. The study will evaluate the stone-free rate as a measure of efficacy, using DMSA scans before and after the procedures. Additionally, it will assess the safety of each surgical method by monitoring intra- and post-operative complications. The goal is to determine which approach is more effective and safer for patients with this condition.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 65 with renal staghorn stones confirmed by imaging.
Not a fit: Patients with renal insufficiency, active urinary tract infections, or other specified exclusions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide patients with a more effective and safer treatment option for staghorn calculi.
How similar studies have performed: Previous studies have shown varying success rates for similar surgical approaches, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Damietta
- Al-Azhar University Hospital (New Damietta) — Damietta, Egypt (Recruiting)
Study contacts
- Principal investigator: Maher Abdelrehem Mohamed, Master — assistant lecturer of urology , Al-Azhar University (Damietta)
- Study coordinator: Maher Abdelrehem Mohamed, Master
- Email: maherabdelrehem2690@gmail.com
- Phone: 01026816086
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.