Percutaneous Nephrolithotomy (PCNL), Renal Stone Disease
Conditions
Keywords
Percutaneous Nephrolithotomy
Brief summary
This comparative study aims to compare and assess the safety, efficacy, outcome, feasibility, intraoperative and postoperative complications of one-shot dilatation versus serial dilatation techniques for access during percutaneous nephrolithotomy for management of renal stone disease in adult patients.
Interventions
PROCEDURErenal dilatation by one-shot dilatation technique
renal dilatation was done by one-shot dilatation technique using 30Fr Amplatz dilator directly over the central Alken rod.
PROCEDURErenal dilatation by metallic telescopic dilators (Alken).
insertion of the Alken guide followed by a telescopic dilator between 9Fr to 30Fr, then an Amplatz sheath 30Fr was advanced over the dilator which was then removed, leaving the Amplatz sheath in the collecting system
PROCEDURErenal dilatation by sequential fascial dilators (Amplatz)
sequential renal dilatation with Amplatz dilator set was used
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged between 18 and 70 years. * Patients with renal stones which their size in maximum diameter is more than 2cm and indicated for percutaneous nephrolithotomy. * Patients clinically fit for surgery. * Patients with normal anatomy of urinary tract. * Patients able to understand the procedure and accept to sign the informed consent.
Exclusion criteria
* Patients aged below 18 or above 70 years. * Patients with renal stones which their size in maximum diameter is less than 2cm or contraindicated for endoscopic management. * Patients with urinary tract infection, abnormal coagulopathy state or clinically unfit for surgery. * Patients with nephrostomy tube in situ. * Patients with more than single access tract. * Patients undergoing simultaneous bilateral stone procedures. * Patients with urinary tract abnormalities or history of renal transplantation. * Renal insufficiency with serum creatinine above 3.0mg/dL * Patients unable to understand the procedure or refuse to sign the informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Fluoroscopy time | From enrollment to the end of treatment at 8 weeks |
| Mean access time | From enrollment to the end of treatment at 8 weeks |
| Stone free rate | From enrollment to the end of treatment at 8 weeks |
| Hospitalization Period | From enrollment to the end of treatment at 8 weeks |
Countries
Egypt
Outcome results
None listed