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Efficacy & Safety of High Power vs. Low Power Holmium Laser in Mini-PCNL for Large Renal Stones

ConditionsRenal StonesRenal Calculi > 2 cm
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMansoura University

About this trial

The investigator will compare between holmium laser setting during miniPCNL for renal stones as regard safety \& efficacy

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

Renal Stones < 20 mm indicated for intervention (pain, infection, obstructing stone causing hydronephrosis or parenchymal affection)

Informed consent obtained

Disqualifiers

Active urinary tract infection

Bleeding diathesis

Pregnancy

Anatomical anomalies impeding access e.g. ectopic malrotated kidneys, crossed fused kidneys...etc.)

Trial design

Design model

Parallel

Treatments tested in this trial

  • mini percutaneous nephrolithotomy

    Procedure/Surgery

    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.

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: high power armExperimental treatment 1 intervention
Group B: low power groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

operative time

time from introduction of nephroscope till nephrostomy tube fixation

Time frame
during mini-PCNL procedure (intraoperative )

Secondary outcomes

1

post operative complication

number of patients that will develop post operative fever, hematuria, or will require blood transfusion

Time frame
2 days
2

stone free rate at 3 month

presence of residual stones requiring reintervention

Time frame
3 month

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mansoura University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: