1658 Participants NeededMy employer runs this trial

Surgery vs Observation for Kidney Stones

(OASIS Trial)

Recruiting at 4 trial locations
RD
BJ
Overseen ByBrian J Augelli, BS
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Children's Hospital of Philadelphia
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two approaches for individuals with asymptomatic kidney stones, meaning the stones do not cause pain or other symptoms. It compares observation (monitoring the stones) and surgery to determine which approach leads to less disruption in daily life. The goal is to identify the most effective strategy for different individuals and understand their preferences. Individuals diagnosed with kidney stones that do not cause symptoms might be suitable candidates for this study. As an unphased trial, this study provides a unique opportunity to contribute to understanding the best management strategies for asymptomatic kidney stones.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that surgeries for kidney stones are generally safe and well-tolerated. Studies have found that procedures like ureteroscopy (using a small scope to remove stones) and percutaneous nephrolithotomy (PCNL, removing stones through a small cut in the back) are very successful. Ureteroscopy achieves about an 88% success rate, while PCNL reaches a 95% success rate after just one surgery.

However, like any surgery, risks exist. Some patients might experience complications such as infections or bleeding. PCNL, for example, may lead to more complications and longer hospital stays compared to other methods. Still, these procedures are considered safe for most people, especially when stones cause problems like pain or blocked urine flow.

Surgery for kidney stones maintains a strong safety record. While complications can occur, they are usually manageable. These findings can help prospective trial participants feel more confident about the safety of surgical treatments.12345

Why are researchers excited about this trial?

Most treatments for kidney stones involve medications to manage pain and assist stone passage or surgeries like ureteroscopy and lithotripsy to physically remove or break up stones. However, researchers are exploring whether surgery is necessary for all cases by comparing it against simple observation. The excitement here lies in potentially identifying cases where surgery might be safely avoided, sparing patients from invasive procedures, recovery time, and associated risks. This approach could lead to more personalized treatment plans, where only those who truly need surgery undergo it, thereby improving patient care and resource management in healthcare.

What evidence suggests that this trial's treatments could be effective for kidney stones?

This trial will compare surgery with observation for kidney stones. Research has shown that surgery effectively removes kidney stones. For stones measuring 1-3 cm, the success rate ranges from 88% to 91%. For stones larger than 3 cm, the success rate is about 75%. Specifically, percutaneous nephrolithotomy achieves a 95% success rate for larger stones, while ureteroscopy has an 88% success rate. These figures suggest that surgery is a reliable option for removing kidney stones, particularly larger ones.14678

Who Is on the Research Team?

GE

Gregory E Tasian, MD, MSc, MSCE

Principal Investigator

Children's Hospital of Philadelphia

Are You a Good Fit for This Trial?

This trial is for children and adults (age 6+) with kidney stones that are not causing symptoms like pain or blood in urine. Stones must be small (4-10 mm), located only in the kidney, and not blocking urine flow. Participants must speak English or Spanish and agree to random assignment or observation.

Inclusion Criteria

I have been diagnosed with kidney stones.
I have not had pain, blood in urine, or nausea from kidney stones in the past 3 months.
I am willing to be randomly assigned to surgery or observation.
See 6 more

Exclusion Criteria

I have a stone in my kidney, ureter, bladder, or urethra.
I have a structural abnormality in my kidney.
I am currently pregnant.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Observation

Surveillance of asymptomatic stones with periodic CT, ultrasound, or x-ray, and clinic visits

24 months
Every 3 months (+/- 14 days)

Upfront Surgery

Planned removal of asymptomatic stones including ureteroscopy (URS) and shockwave lithotripsy (SWL)

Varies based on procedure

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months
Every 3 months (+/- 14 days)

What Are the Treatments Tested in This Trial?

Interventions

  • Observation
  • Surgery

Trial Overview

The study compares two approaches for people with symptom-free kidney stones: having surgery right away versus simply monitoring the stones without immediate treatment. Participants are randomly assigned to either group, unless they choose just to be observed.

How Is the Trial Designed?

2

Treatment groups

Active Control

Group I: Non-Randomized (Observational)Active Control2 Interventions
Group II: RandomizedActive Control2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Children's Hospital of Philadelphia

Lead Sponsor

Trials
749
Recruited
11,400,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials
592
Recruited
27,110,000+

Citations

Efficacy of surgical techniques and factors affecting residual ...

reported 88–91% success rates for stones with a diameter of 1–3 cm, mean success rate decreased to 75% in stones larger than 3 cm in diameter.

Studies Examine Effectiveness of Surgeries on Pediatric ...

The results of the second study showed that for larger stones, percutaneous nephrolithotomy had better stone clearance and better lived experiences in patients ...

Kidney Stone Treatment

ESWL works best for smaller kidney stones (less than 2 cm Patients may experience some blood in their urine and discomfort as stone fragments pass.

Surgical outcomes of robotic surgery for kidney stones: a ...

In the study conducted by Frankhauser et al., the success rate of F-URS for stones less than 2 cm was found to be 84% [20]. In this meta- ...

Outcomes of the Surgical Stone Management in Pelvic ...

This was a retrospective, comparative study evaluating the surgical outcomes of different treatment modalities for pelvic ectopic kidney stones ...

Safety, feasibility, and efficacy of surgical intervention for ...

... safety outcomes of M-PCNL and S-PCNL for managing renal calculi. Findings reveal that M-PCNL had a longer operation time (133.73 ± 29.18 min) than S-PCNL ...

Surgical Management of Kidney and Ureteral Stones

This Guideline covers the surgical management of patients with kidney and/or ureteral stones and is intended for clinicians evaluating and managing patients ...

Surgery for Kidney Stones

SWL is a safe and effective procedure for kidney stones and has an excellent track record. However, as with any surgical procedure, problems can occur. Major ...