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Procedure
Ambulatory vs Inpatient Surgery for Kidney Stones
N/A
Waitlist Available
Led By Thomas Chi, MD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18 years or more
Absence of renal anatomic abnormalities
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 week after surgery
Awards & highlights
Study Summary
This trial will compare the safety and effectiveness of a new minimally-invasive surgery for kidney stones to the current standard.
Who is the study for?
This trial is for adults over 18 scheduled for PCNL (a procedure to remove kidney stones) who consent to participate. It includes those with bilateral procedures or pre-operative stents/tubes and without renal abnormalities. Excluded are individuals with post-op complications, under 18, pregnant, recent urine infections, bleeding disorders, a solitary kidney, significant operative injuries or hemorrhage.Check my eligibility
What is being tested?
The study compares two methods of removing kidney stones: ambulatory tubeless PCNL where patients go home the same day without a nephrostomy tube versus traditional inpatient PCNL where they stay in the hospital with a tube. The aim is to see if the outpatient approach is as safe and effective.See study design
What are the potential side effects?
Potential side effects include pain at the surgical site, bleeding that may require transfusion, infection risks like fever or positive urine culture within three weeks after surgery. There's also a risk of respiratory issues such as pneumothorax (air in chest cavity) or hemothorax (blood in chest cavity).
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
My kidneys are structurally normal.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 week after surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 week after surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Total number of complications
Secondary outcome measures
Operative Surgical Procedures
Cumulative opiate morphine equivalent dosing
Return to work
+2 moreTrial Design
2Treatment groups
Active Control
Group I: Ambulatory tubeless PCNLActive Control1 Intervention
Patients will be discharged home on the same day as surgery. No nephrostomy tube will be placed (tubeless).
Group II: Inpatient PCNL with nephrostomy tubeActive Control1 Intervention
Patients will be admitted to hospital for 1-3 days with a nephrostomy tube placed at the time of surgery that will then be removed prior to discharge.
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Who is running the clinical trial?
Queen's UniversityOTHER
365 Previous Clinical Trials
120,277 Total Patients Enrolled
2 Trials studying Kidney Stones
58 Patients Enrolled for Kidney Stones
University of California, San FranciscoLead Sponsor
2,500 Previous Clinical Trials
15,236,331 Total Patients Enrolled
2 Trials studying Kidney Stones
3,471 Patients Enrolled for Kidney Stones
Thomas Chi, MDPrincipal InvestigatorUniversity of California, San Francisco
5 Previous Clinical Trials
360 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am scheduled for a kidney stone removal surgery and agree to participate in the study.I am 18 years old or older.I received a blood transfusion after surgery.My doctor says I need to be admitted for surgery due to other health issues.I experienced significant bleeding during surgery.Your hemoglobin level dropped by more than 3 g/dL after surgery compared to before the surgery.I had a significant injury to my urinary system during surgery.After surgery, your body temperature is higher than 100.4 degrees Fahrenheit.I have stable heart rate, breathing, and blood pressure after surgery.I am younger than 18 years old.I had air or blood in my chest seen on an X-ray after surgery.You had a urine infection within 3 weeks before the surgery.I have a condition that affects my blood's ability to clot.I have a kidney shape or structure issue.I have only one kidney.I have uncontrolled nausea, vomiting, or pain after surgery.I am having surgery on both sides or have tubes in my urinary system.My kidneys are structurally normal.
Research Study Groups:
This trial has the following groups:- Group 1: Ambulatory tubeless PCNL
- Group 2: Inpatient PCNL with nephrostomy tube
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are involved in this clinical research?
"Indeed, the information provided on clinicaltrials.gov confirms that enrollment for this research project is still open. It was initially launched on August 1st 2022 and last updated on September 13th 2022. The recruitment of 140 participants will take place at a single medical centre."
Answered by AI
Is there still an opportunity to join this research endeavor?
"Affirmative. The information contained on clinicaltrials.gov verifies that the trial is currently recruiting patients, with an initial post date of August 1st 2022 and a most recent update taking place September 13th 2022. 140 participants are sought from one location across the country."
Answered by AI
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