Renal Stones
Conditions
Brief summary
Few studies compared PCNL and RIRS for stones in solitary kidney. Current guidelines do not provide clear recommendations concerning the management of renal stones in patients with solitary kidney. The study aims to compare the safety and efficacy of the use of percutaneous nephrolithotomy (PCNL) and flexible ureteroscopy in the treatment of renal stones \_ ≤ 3 cm in largest diameter through a prospective non randomized study in the period between August 2024 and August 2026. Stone-free rate will be assessed by NCCT done at 1st day postoperative and after 3 months. For Evaluation of kidney function postoperatively, creatinine clearance will be done after 1month and renal isotope scan will be done after 3 months. In addition, the results will be compared to the data of the patients with solitary kidney and renal stones who were retrospectively treated by PCNL or RIRS in the period between 2002 and 2024. The cases should fulfil the same inclusion criteria of the prospective study.
Interventions
PROCEDUREretrograde intra renal surgery (RIRS)
standard retrograde intrarenal surgery (RIRS) for management of stones in solitary kidney
PROCEDUREpercutaneous nephrolithotomy (PCNL)
standard percutaneous nephrolithotomy (PCNL) for management of stones in solitary kidney
Sponsors
Mansoura University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with anatomical or functional solitary kidney. * Renal stones ≤ 3 cm in largest diameter- as measured by non-contrast spiral CT * Age ≥ 18 years.
Exclusion criteria
* Patients who did not meet the above criteria. * bleeding diathesis or those on anticoagulant therapy. * concomitant pathology as ureteric stricture or renal congenital anomalies .
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| stone free rate | within 3 months after surgery | Stone-free status: it will be assessed by NCCT (defined as the absence of any stones or presence of only clinically insignificant residual stones \< 4 mm as measured by NCCT). Sub classified to * Initial stone free rate (1st day postoperative) * Final stone free rate (after 3 months) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| complication rate | within 30 days after surgery | intra-operative and post operative complications according to clavien- dindo classification |
| number of sessions | 3 months after surgery | number of sessions needed to achieve complete stone clearance |
| renal function evaluation | within 3 months after surgery | renal function assessed by eGFR |
| auxiliary procedures | within 3 months after surgery | need for auxiliary procedures after primary intervention |
| hospital stay | from date of surgery until hospital discharge ( up to 30 days ) | duration of postoperative hospital stay |
Countries
Egypt
Contacts
PRINCIPAL_INVESTIGATORAhmed M. Shoma, Professor of urology
Urology and Nephrology Center , Mansoura university , Egypt
Outcome results
None listed