Efficacy and Safety of Flexible Ureteroscopy Versus Percutaneous Nephrolithotomy in Management of Staghorn Stones
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Percutaneous nephrolithotomy, Flexible ureteroscopy.
- Who it may be relevant to
- Registry conditions: Renal Stones. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy and Safety of Flexible Ureteroscopy Versus Percutaneous Nephrolithotomy in Management of Staghorn Stones: A Randomized Controlled Trial
Overview
Percutaneous nephrolithotomy (PCNL) is considered the treatment of choice for management of large renal calculi larger than 2 cm based on the yearly updated European Association of Urology (EAU) guidelines. However, PCNL is a challenging procedure which may be associated with several complications ranging from mild complications, such as urinary extravasation, leakage, infection and bleeding requiring transfusion to sever complications, such as sepsis, injury to surrounding organs, persistent hematuria and renal function impairment. The overall complication rate varies based on patient factors and surgical expertise. Not only serious complications that defer some endourologists from performing PCNL but also such procedure is contraindicated and avoided by surgeons in cases of retrorenal colon, morbidly obese patients, spinal abnormalities and bleeding diathesis. Therefore, retrograde intrarenal surgery (RIRS) or flexible ureteroscopy (FURS) is increasingly recognized as an effective alternative, particularly for patients seeking a minimally invasive approach with a lower risk of complications. The best practice in dealing with renal stones using FURS can be achieved via preoperative stenting for 2-4 weeks, negative urine culture, ureteral access sheath (UAS) usage and optimizing laser settings. Compared to PCNL, FURS is a less challenging procedure with low learning curve, less invasive and less bleeding. However, the high cost, including laser usage cost, presenting costs and multisession costs, in addition to the high risk of postoperative infection are considered as major drawbacks of FURS. RIRS is emerging as an effective, safe, minimally invasive alternative to PCNL. Yet, the success of RIRS in comparison to PCNL, especially in a single session, is still questionable and there is no consensus about it.
Interventions
- Procedure Percutaneous nephrolithotomy
This intervention includes percutaneous nephrolithotomy for lithotripsy of staghorn stone - Procedure Flexible ureteroscopy
This intervention includes Flexible ureteroscopy for lithotripsy of staghorn stone
Primary outcome measures
- Stone free rate [Time frame: 1 Month]
Secondary outcome measures (3)
- Operative time [Time frame: During the surgery]
- Complications [Time frame: 1 month]
- Radiation time [Time frame: During the surgery]
Eligibility criteria
Inclusion criteria
- Adults aged ≥18 years.
- Diagnosis of complete staghorn renal stones confirmed by non-contrast CT.
- Negative urine culture.
Exclusion criteria
- Congenital renal anomalies (e.g., horseshoe kidney, malrotation).
- Coagulopathy or uncorrected bleeding disorder.
- Pregnancy.
- Previous ipsilateral renal surgery.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Menoufia Faculty of Medicine — Shebin El-Kom
Identifiers
NCT: NCT07322471 · PCNL vs FURS in staghorn stone