A Randomized Controlled Trial Comparing Ultrasound Versus Fluoroscopy Guided Percutaneous Nephrolithotomy.
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- AIIMS Kalyani
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- To compare the calyceal puncture time, tract dilatation time and stone-free status between ultrasound-guided and fluoroscopic-guided PCNL
Overview
Brief Summary
This is a single center, prospective, randomized controlled trial comparing ultrasound guided versus fluoroscopy guided Percutaneous Nephrolithotomy in patients falling under inclusion criteia.The study aims to evaluate intraoperative parameters like Calyceal puncture time, tract dilatation time and stone free status, as well as secondary outcomes such as radiation exposure time, complications like bleeding, infection.Patients will be randomly assigned to either Group A or Group B with all the other surgical tips standardized.
Hypothesis of the study is that ultrasound guided Percutaneous Nephrolithotomy is non inferior to fluoroscopic guided Percutaneous Nephrolithotomy in terms of stone free status and radiation exposure time.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant, Investigator and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 80.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients with renal calculi size more than or equal to 2 cm.
- •Patients with staghorn calculus.
Exclusion Criteria
- •Paediatric age group.
- •Urinary tract Anomalies like Horseshoe kidney, Crossed ectopic kidney and Fused ectopic kidney.
- •Uncorrected bleeding disorders or Coagulopathies.
- •Active urinary tract infection at time of surgery.
- •Post renal transplant.
Outcomes
Primary Outcomes
To compare the calyceal puncture time, tract dilatation time and stone-free status between ultrasound-guided and fluoroscopic-guided PCNL
Time Frame: inta-op, intra-op, intra-op and 4 weeks
Secondary Outcomes
- Radiation exposure time,(Evaluation of safety profile- Bleeding and Infection)
Investigators
Nirmalya Ghosh
AIIMS Kalyani