Menoufia Faculty of Medicine
Shebin El-Kom, Menoufia, 32511, Egypt
NCT Number: NCT07322471
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Shebin El-Kom, Menoufia, 32511, Egypt
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
This intervention includes percutaneous nephrolithotomy for lithotripsy of staghorn stone
This intervention includes Flexible ureteroscopy for lithotripsy of staghorn stone
Time frame: 1 Month
Stone-free rate (SFR), defined as no clinically significant residual stones on non-contrast 3-mm-cuts CT, measured as yes or no.
Time frame: During the surgery
Operative time is defined as time between starting the procedure and termination of it measured in minutes
Time frame: 1 month
Intra and postoperative complications, defined as complications happens intraoperative and postoperatively, graded by modified clavien-dindo classification
Time frame: During the surgery
Radiation time, defined as time in which ionizing radiation used intraoperatively, measured in minutes
Contact information is provided by the study sponsor or research team.
Menoufia University
Other
Efficacy and Safety of Flexible Ureteroscopy Versus Percutaneous Nephrolithotomy in Management of Staghorn Stones: A Randomized Controlled Trial
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