Stone;Renal
Conditions
Brief summary
Management of nephrolithiasis is evolving rapidly, and various minimally-invasive urological procedures are currently available for treating patients with renal stones, including extracorporeal shockwave lithotripsy (ESWL), flexible ureteroscopy (f-URS) and miniaturised percutaneous nephrolithotomy (mini-PCNL). Despite being the only truly-non-invasive, outpatient procedure, stone-free rates (SFRs) of ESWL are lower than both mini-PCNL and f-URS. Furthermore, ESWL has several limitations, such as pregnancy; uncorrected coagulopathy;aortic aneurism; severe obesity; large stone burdens (\>2cm); stones with high densities (\>970/1000 Hounsfield units); ESWL-resistant stone compositions; lower calyceal stones with unfavourable anatomical criteria; and stones in calyceal diverticula; Morbidities of the conventional PCNL are significantly minimised by using less access diameters in PCNL while providing comparable SFRs. Additionally, Mini and Micro PCNL result in shorter hospital stay and higher tubeless rates compared to conventional PCNL. Flexible ureteroscopy has been increasingly used as a primary modality for treatment of renal stones with significantly lower complication rates than PCNL and mini-PCNL in terms of less bleeding and transfusion rates, shorter hospital stay and less postoperative pain. Additionally, f-URS is the only treatment modality of nephrolithiasis that can be safely and effectively used in patients with bleeding tendency, as well as pregnant women; moreover, its outcomes are not affected by obesity. Nevertheless, its poor durability and high costs remain major limitations for f-URS, especially in developing countries.
Interventions
PROCEDUREFlexible ureteroscopy
The procedure will be performed in an endourology room where a radiolucent operative table together with a C-arm, a video-camera unit and a Laser device are available. Irrigation fluids include normal saline and/or sterile water.
PROCEDUREmini-Percutaneus nephrolithotomy
The procedure is done in the prone position under fluoroscopy guidance with a semi-rigid 12Fr. Nephroscope
Sponsors
Assiut University
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
16 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
* Age above than 15 years * Renal stone(s) with total burden of 2 cm or less * Signature on written, informed consents with the details of this study requirements. * Inappropriateness or failure of ESWL (examples of ESWL inappropriateness: patient preference; distal obstruction; contraindications of ESWL)
Exclusion criteria
* Uncorrectable bleeding diathesis * Current pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| final stone clearance | 90 days after the operation | Number of participants who has been totally cleared of stones as measured by non-contrast CT |
| initial stone clearance | 24 hours after the operation | Number of participants who has been totally cleared of stones as measured by KUB and ultrasound |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operative time | Within 24 hours | time passed during the operation |
| Hospital stay | Within a week from the operation | Number of days the patient has been hospitalised |
| Haemoglobin drop | within 24 hours | The percentage of haemoglobin drop before and after the operation |
Countries
Egypt
Outcome results
None listed