Endoscopic Combined Intrarenal Surgery for Management of Large Renal Stones: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Benha University
- Enrollment
- 150
- Locations
- 2
- Primary Endpoint
- Stone Free Rate
Study Overview
Brief Summary
currently, percutaneous nephrolithotomy (PCNL) is the standard procedure of choice for management of large renal more than 2 cm.
the pivotal step in performing PCNL is creation of proper tract. this step can be done monitored under guidance of different modalities such as fluoroscopy, ultrasonography, endoscopy or combined in ECIRS, tract creation is controlled under endoscopic vision with a flexible ureteroscope .
Detailed Description
Aim: compare safety and efficacy and adverse events of ECIRS in comparison of standard fluoroscopic guided PCNL.
patients & methods: Patients will randomly be divided into two equal groups:
Group A: Patient will undergo ECIRS.
Group B: Patient will undergo standard PCNL
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •patients with renal stones diameter of at least 2 cm.
- •American Society of Anesthesiology score ≤ 2.
Exclusion Criteria
- •patients with renal anomalies.
- •transplanted kidney.
- •uncorrected coagulopathy.
- •active infection.
Outcomes
Primary Outcomes
Stone Free Rate
Time Frame: 3 months post-operative
If their is any residual stones
Secondary Outcomes
- operative time(intra oprative)
- blood loss(pre-operative and 1 day post-oprative)
Investigators
Waleed El-Shaer, MD
Associate professor
Benha University