Efficacy & Safety of High Power vs. Low Power Holmium Laser in Mini-PCNL for Large Renal Stones
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: mini percutaneous nephrolithotomy.
- Who it may be relevant to
- Registry conditions: Renal Stones, Renal Calculi > 2 cm. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
High Pulse Power vs. Low Pulse Power Holmium: YAG Laser in Mini-Percutaneous Nephrolithotomy for Management of Renal Stones > 20 mm: A Randomized Controlled Trial
Overview
The investigator will compare between holmium laser setting during miniPCNL for renal stones as regard safety \& efficacy
Detailed description
The first 80 consecutive Patients presented to the department of urology, Mansoura Urology and Nephrology Center and fulfilling the inclusion criteria will be included in the present study.
Preoperatively, all patients will be thoroughly evaluated by medical history and physical examination including body mass index (BMI), laboratory assessment (including urine analysis/culture, serum biochemistry, CBC, bleeding profile).
Radiological assessment will include plain X-ray Kidney-Ureter-Bladder (KUB), abdominal ultrasound and non-contrast computed tomography (NCCT).
NCCT images will be obtained from above the kidneys through the bladder base. For each renal stone, location, largest diameter, burden and density will be assessed.
Culture based antibiotic is given. Under spinal anaesthesia, the patient is initially placed in lithotomy position for retrograde ureteral catheter placement, then repositioned to prone or modified supine position for percutaneous access.
Under fluoroscopic guidance, an 18G Chiba needle is used to access a posterior calyx or the appropriate target calyx). Contrast confirms the collecting system entry.
Dilation is performed, typically up to 14-20 Fr. A mini-nephroscope (15 Fr) is inserted through an appropriate sheath. Irrigation is maintained using gravity or low-pressure systems.
Holmium: YAG laser is used for lithotripsy. high pulse power will be capped at 40 W, while low pulse power settings will remain between 10-20 W. Fragments are evacuated via vacuum cleaner effect or basket through the sheath.
Depending on intraoperative findings, a nephrostomy tube and/or double-J stent may be placed. Tubeless approach may be considered.
Interventions
- Procedure mini percutaneous nephrolithotomy
Under fluoroscopic guidance, an 18G Chiba needle is used to access a posterior calyx or the appropriate target calyx). Contrast confirms the collecting system entry. Dilation is performed, typically up to 14-20 Fr. A mini-nephroscope (15 Fr) is inserted through an appropriate sheath. Irrigation is maintained using gravity or low-pressure systems. Holmium: YAG laser is used for lithotripsy. high pulse power will be capped at 40 W, while low pulse power settings will remain between 10-20 W. Frag
Primary outcome measures
- operative time [Time frame: during mini-PCNL procedure (intraoperative )]
Secondary outcome measures (2)
- post operative complication [Time frame: 2 days]
- stone free rate at 3 month [Time frame: 3 month]
Eligibility criteria
Inclusion criteria
- Age ≥ 18 years
- Renal Stones < 20 mm indicated for intervention (pain, infection, obstructing stone causing hydronephrosis or parenchymal affection)
- Informed consent obtained
Exclusion criteria
- Active urinary tract infection
- Bleeding diathesis
- Pregnancy
- Anatomical anomalies impeding access e.g. ectopic malrotated kidneys, crossed fused kidneys...etc.)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07393178 · MS.25.08.3291