Actively Recruiting
Efficacy and Safety of Endoscopic Combined Intrarenal Surgery versus Percutaneous Nephrolithotomy for Treatment of Staghorn Calculi, A Prospective Randomized Study
Led by Al-Azhar University · Updated on 2024-07-25
100
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a prospective randomized study to compare two surgical methods—endoscopic combined intrarenal surgery (ECIRS) and percutaneous nephrolithotomy (PCNL)—for treating staghorn kidney stones. The study aims to evaluate how well each procedure works and how safe they are by looking at stone-free rates and complications during and after surgery. The trial involves two groups of patients: one group of 50 patients will undergo PCNL, and another group of 50 patients will receive ECIRS. Both procedures target staghorn stones, which are large kidney stones occupying the renal pelvis and extending into multiple calyces. Researchers will assess efficacy using stone-free rates three months after surgery and will use DMSA scans before and after procedures to evaluate kidney function. Participants will be closely monitored for safety by tracking complications during surgery, on the first postoperative day, and up to three months after the procedure. The study will include imaging and clinical assessments to measure outcomes. Patients aged 18 to 65 with staghorn stones are eligible, and the study will last until June 2025, with regular follow-up visits to evaluate results and safety.
CONDITIONS
Brief Title
Endoscopic Combined Intrarenal Surgery vs. Percutaneous Nephrolithotomy for Treatment of Staghorn Calculi
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients are more than 18 and less than 65 years old.
- Patients with renal staghorn stones confirmed by imaging showing stones occupying the renal pelvis and extending into at least 2 major calyces.
You will not qualify if you...
- 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single surgical procedure with early postoperative period
Participants undergo either endoscopic combined intrarenal surgery or percutaneous nephrolithotomy to treat staghorn stones.
1 surgery visit and approximately 2 follow-up visits within the first day and early postoperative period
Duration - Up to 3 months post-surgery
Participants are monitored for safety and effectiveness of the procedure, including assessment of stone-free rate and complications.
Approximately 3 follow-up visits over 3 months
Trial Site Locations
Total: 1 location
1
Al-Azhar University Hospital (New Damietta)
Damietta, Egypt, 952567
Actively Recruiting
Research Team
M
Maher Abdelrehem Mohamed, Master
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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