Stent Omission vs Placement for Kidney Stones
(ACCENT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if skipping a stent after kidney stone surgery is as effective as using one. Researchers seek to understand whether omitting the stent affects pain and healthcare visits afterward. Participants must have kidney or ureteral stones and plan to undergo surgery using a Ureteral Access Sheath. The study seeks individuals comfortable answering questions about their pain and recovery after surgery. As an unphased trial, it offers participants the chance to contribute to important research that could enhance post-surgery recovery experiences.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
What prior data suggests that this protocol is safe for patients undergoing ureteroscopy?
Research shows that using a ureteral access sheath (UAS) during kidney stone procedures is generally safe. Studies indicate that the UAS is well-tolerated and effective, even for larger kidney stones. It has been used safely in both adults and children, yielding good results with few complications.
When deciding whether to place a stent after using a UAS, the focus remains on the safety of each option. Stents often keep the ureter open after surgery, aiding healing. However, skipping a stent might reduce discomfort and decrease healthcare visits within 30 days. The studies aim to confirm if omitting a stent is as safe as using one, based on patient feedback and recovery experiences.
Overall, evidence suggests that both using a UAS and the decision to use or skip a stent are safe practices, with careful monitoring by the medical team.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores whether skipping the use of stents after kidney stone procedures can be just as effective as placing them. Typically, stents are used to ensure urine can flow freely after a ureteroscopy, but they can cause discomfort and require follow-up removal. By comparing outcomes with and without stents, the trial aims to find out if omitting stents could mean less pain and fewer follow-up visits for patients, without compromising on safety or effectiveness. This could lead to a simpler, more comfortable recovery process for those undergoing treatment for kidney stones.
What evidence suggests that this trial's treatments could be effective for kidney stones?
Research shows that using a ureteral access sheath (UAS) during kidney stone removal can improve outcomes. In previous studies, patients were completely free of stones about 85% of the time. A UAS also reduces infection-related complications and shortens surgery time. This trial will divide participants into two groups: one in the stent omission arm and the other in the stent placement arm. The decision to use a stent after the procedure depends on patient comfort and healthcare needs over the next 30 days. Current evidence suggests that omitting a stent might manage pain effectively and reduce the need for follow-up healthcare.25678
Who Is on the Research Team?
Khurshid Ghani, MD
Principal Investigator
University of Michigan
Are You a Good Fit for This Trial?
This trial is for individuals planning to undergo a single procedure for unilateral kidney or ureteral stones, without significant ureteral injury. Participants must be able to complete surveys and adhere to study procedures throughout the duration of the study. They should have consented in writing and be pre-stented with an existing ureteral stent.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo ureteroscopy and lithotripsy for stone disease, followed by randomization to stent omission or stent placement
Follow-up
Participants are monitored for safety and effectiveness, including assessments of pain interference, pain intensity, urinary symptoms, and treatment satisfaction
Extended Follow-up
Participants are monitored for healthcare utilization and stone-free rates
What Are the Treatments Tested in This Trial?
Interventions
- Access Sheath
- Stent
Trial Overview
The trial compares patient outcomes when omitting or placing a stent after using a Ureteral Access Sheath (UAS) during uncomplicated ureteroscopy. Patients will answer questionnaires about their pain and healthcare use post-surgery, with random assignment to either the stent omission group or the stent placement group.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Participants will complete surveys before and after a planned ureteroscopy and lithotripsy for stone disease.
Participants will complete surveys before and after a planned ureteroscopy and lithotripsy for stone disease.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Michigan
Lead Sponsor
Citations
Retrospective analysis of flexible ureteroscopic lithotripsy ...
Flexible ureteroscopic lithotripsy using F-UAS improves stone clearance, reduces infection-related complications, and shortens operation time ...
Full article: The efficacy of flexible ureteroscopy for large ...
Complete stone-free status was achieved in 84.9% of the patients. No significant difference was detected between both groups regarding operative ...
A Feasibility Study on the Efficacy and Safety of a Novel Tip ...
Conclusion: NFTS-UAS combined with FURS achieved satisfactory outcomes with good efficacy and safety for treating large renal stones ≥30 mm, and it can be ...
Safety and Efficacy of Traditional Versus Suction Ureteral ...
The results of this study aim to provide evidence on whether suction UAS improves safety or effectiveness in RIRS compared with the traditional ...
Suction Ureteral Access Sheaths During Flexible ...
In the S-UAS group, 37 patients (74%) had multiple stones, and 11 patients (22%) had more than five stones, compared with 31 patients (62%) and ...
Outcomes of ureteroscopy and laser lithotripsy with and ...
The primary outcome measures were stone-free rate (SFR), and post-operative complications. Secondary outcomes were operative time (OT), hospital length of stay ...
Safety and Outcomes of using ureteric access sheath (UAS ...
Ureteral access sheath is safe for treatment of pediatric renal stones with excellent outcomes and are especially useful for larger or multiple stones.
IP13-32 RIRS WITH USING FLEXIBLE VACUUM ...
The purpose of the study is to evaluate the effectiveness and safety of using a flexible vacuum-assisted ureteral access sheath (fVA-UAS) when ...
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