← Back to Search

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

Must not have

Post-operative: Transfusion of blood products

Intra-operative: Significant intraoperative hemorrhage

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 week after surgery

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

Select...

I am 18 years old or older.

Select...

My kidneys are structurally normal.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I received a blood transfusion after surgery.

Select...

I experienced significant bleeding during surgery.

Select...

I had a significant injury to my urinary system during surgery.

Select...

I have stable heart rate, breathing, and blood pressure after surgery.

Select...

I am younger than 18 years old.

Select...

I had air or blood in my chest seen on an X-ray after surgery.

Select...

I have a condition that affects my blood's ability to clot.

Select...

I have a kidney shape or structure issue.

Select...

I have only one kidney.

Select...

I have uncontrolled nausea, vomiting, or pain after surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 week after surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 week after surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 week after surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Total number of complications

Secondary study objectives

Operative Surgical Procedures

Cumulative opiate morphine equivalent dosing

Return to work

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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.

0 / 12Eligibility criteria met