Renal Stone
Conditions
Keywords
ECIRS, PCNL, Obese
Brief summary
Primary aim: comparing the efficacy of standard PCNL and endoscopic combined intrarenal surgery (ECIRS) in the Galdakao-modified Supine Valdivia (GMSV) position in a single session for the treatment of complex nephrolithiasis in obese patients. Secondary aim: comparing safety and complications of standard PCNL and ECIRS in the GMSV.
Detailed description
Complex nephrolithiasis including multiple peripheral or branched (partial or complete staghorn calculi) renal stones, is still currently an intractable problem for urologists to achieve stone-free status and minimize complication rates. According to the European Association of Urology Urolithiasis Guidelines, retrograde intrarenal surgery (RIRS) is recommended as first-line treatment for renal stones \< 2 cm, and percutaneous nephrolithotomy (PCNL) is recommended as the gold standard for renal stones ≥ 2 cm in length. Obesity has been identified as an independent risk factor for stone formation in the United States. Obesity (BMI \>35) also places surgical patients at a greater risk of complications, because of the increased incidence in this group of diabetes, hypertension, ischemic heart disease, postoperative deep venous thrombosis, and pulmonary embolism, and because of poor radiographic visualization, obscure anatomic landmarks, more difficult renal access, and inferior stone-free rates. Standard percutaneous nephrolithotomy (PCNL) is the recommended treatment by major guidelines. However, multiple tracts or sessions of PCNL were required to obtain a high stone-free rate (SFR) for complex renal calculi, especially staghorn stones, while procedure-related complications increased concomitantly. To acquire a higher SFR, full access to the entire intrarenal collecting system is the final goal of treatment for these patients suffering from multiple calyceal or peripheral satellite calculi, which is technically challenging by means of RIRS or PCNL monotherapy.
Interventions
PROCEDUREEndoscopic combined intrarenal surgery
Combined complex stone clearance with mini-nephroscope and flexible URS
PROCEDUREPercutaneous nephrolithotomy
Clearance of renal stone with nephroscope in prone position
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
1st patient in the PCNL group , 2nd patient in ECIRS group and so on .
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Partial or complete staghorn stones) * Guy's Stone Score III or IV) * Adult (18-60) years old patients * Obese & super-obese patients (BMI \> 30 kg/m 2).
Exclusion criteria
* Patients with congenital renal anomalies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of PCNL vs ECIRS | 2 days | Operative duration in minutes (from positioning to the end of the procedure) will be recorded for the two groups Stone-free status will be evaluated with a plain abdominal radiograph of the kidneys, ureters, and bladder (KUB) for radiopaque stones and NCCT for lucent stones before hospital discharge. Stone-free status is defined as no or small calyceal residuals of ≤ 4 mm (clinically insignificant residual fragment) without infection. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety and complication of PCNL Vs ECIRS | 1 month. | Intraoperative complications will be recorded and 30-day postoperative complications will be graded according to the modified Clavien classification. |
Countries
Egypt
Contacts
Primary ContactMoataz bellah M. Adel, Master degree
Backup ContactAhmed M. Higazy, Phd
Outcome results
None listed