Miniaturized Percutaneous Nephrolithotomy for Kidney Stones
This study is comparing two ways to perform a surgery called miniaturized percutaneous nephrolithotomy (mini-PCNL) for kidney stones. This surgery involves making a small opening in your back to reach and remove kidney stones. Researchers are comparing a vacuum-assisted sheath (a device that helps with suction and irrigation during surgery) to a conventional sheath (a standard device for stone removal). Both methods are already used and considered safe and effective for kidney stones. The study aims to see how well each method clears stones (stone-free rate) and to look at surgical details and recovery. Approximately 90 people will participate. You may be eligible if you are 18 or older, have a kidney stone between 10-25 mm, and are planning to have a mini-PCNL.
- Study design
- This is a randomized controlled trial comparing two surgical devices. Approximately 90 participants will be enrolled.
- What's involved
- You would undergo the mini-PCNL surgery and have follow-up appointments for about 4-6 weeks after the procedure.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for approximately 4-6 weeks after surgery for a follow-up appointment with the surgeon.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Randomized Controlled Trial of Miniaturized Percutaneous Nephrolithotomy With Vacuum-Assisted Access Sheaths Versus Conventional Sheaths for Treatment of Nephrolithiasis
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Sriharan Sivalingam · PRINCIPAL_INVESTIGATOR · Principal Investigator
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Inclusion
Exclusion
What this trial measures
- Aim 1: Stone free rate6 weeks
The primary outcome of SFR will be measured using conventional follow up of post-operative NCCT at 6 weeks. NCCT provides the most definitive assessment for post-operative stone burden and allows assessment of radiolucent stones when compared to ultrasound or abdominal x-ray
- Aim 2: Intraoperative variables3-7 days
Patients with positive cultures will be treated with appropriate pre-operative antibiotics between 3 to 7 days depending on symptoms. Antibiotics on day of surgery will be selected according to their last pre-operative urine culture which is our standard of care for patients undergoing PCNL
- Aim 3: Post-operative Outcomes and Complications1 day
Post-operative pain scores will be evaluated using a visual analogue scale (VAS) in the post-anesthesia care unit (PACU) and on postoperative day 1. The questionnaire may be filled out on a paper survey or an electronic REDCap survey sent via email. An electronic VAS has shown to be reliable and interchangeable with a paper VAS