CTRI/2024/07/071294
Not yet recruiting
Phase 4
Comparison of double-J stenting versus ureteral catheters in percutaneous nephrolithotomy
Not provided1 site in 1 country200 target enrollmentStarted: August 12, 2024Last updated:
Overview
- Phase
- Phase 4
- Status
- Not yet recruiting
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- To determine if ureteral Catheters have significantly reduced stent related complications when compared with double J stenting
Overview
Brief Summary
This randomised control trial (open label) aims at comparing the placement of uretral catheters in patient post PCNL (intervention) with those in whom double J stents have been placed (the accepted standard). The study primarily aims to determine if the stent related symptoms are significantly less in ureteral catheter arm and secondarily to determine if there is any significant increase in other post operative complications (urinary extravasation, bleeding)
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- None
Eligibility Criteria
- Ages
- 12.00 Year(s) to 80.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients of ages above 12 years undergoing PCNL in department of Urology in IPGMER, KOLKATA.
- •Cumulative stone diameter ≤ 4 cm No ureteral obstruction Up to two access sites Those consented to be part of study.
Exclusion Criteria
- •Patient who did not gave consent for the study Patients below age of 12 years Cumulative stone diameter more than 4 cm Presence of ureteral obstruction More than 2 access sites.
Outcomes
Primary Outcomes
To determine if ureteral Catheters have significantly reduced stent related complications when compared with double J stenting
Time Frame: Day 1 | Day 2 | 2 Weeks
Secondary Outcomes
- To determine if ureteral catheters have comparable rates of complications for urinary extravasation and need for blood transfusion with double J stents(Day 1)
Investigators
Suhan Khamar
IPGMER and SSKMH
Study Sites (1)
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