Prospective Randomized Study on the Necessity of Postoperative Stenting After Ureteroscopy (URS) for Ureteral Stones.
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Lukas J Hefermehl
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Postoperative pain assessment
Overview
Brief Summary
Comparison of routine postoperative stenting versus no stenting after ureterorenoscopy for ureteral stones to assess the necessity and impact on complication risk.
Detailed Description
After a ureteroscopy (URS) for the removal of ureteral stones, a double-J stent is routinely placed. Among other measures, this is intended to prevent pain caused by ureteral swelling, small residual fragments, blood clots, and potential drainage obstructions, which could lead to colic or fever. However, the evidence supporting the benefit of this practice is limited. At the same time, many patients report discomfort due to the stent (e.g., flank pain, dysuria, frequent urination, hematuria), which can significantly impact their quality of life.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 18 years or older
- •Patients with ureteral stones scheduled for ureteroscopy (URS) and stone removal
- •Previous pre-stenting
- •Informed Consent as documented
Exclusion Criteria
- •Complex ureteral conditions (e.g., known ureteral strictures)
- •Impacted stones
- •Solitary kidney
- •Patients with significant renal stones (\>3mm)
- •Previous ureteral surgeries (except endoscopic stone treatments)
- •Pregnancy or suspected pregnancy
Arms & Interventions
No-Stent Group
No postoperative double-J catheter following ureterorenoscopy.
Intervention: No Double-J catheter insertion (Other)
Stent Group
Routine postoperative double-J catheter insertion following ureterorenoscopy.
Intervention: Double-J catheter (Procedure)
Outcomes
Primary Outcomes
Postoperative pain assessment
Time Frame: up to 4 weeks postoperative
Assessment of postoperative pain will be conducted using the Visual Analogue Scale (VAS) and the study-specific mobile application HEATMAP (Byldr GmbH, Switzerland). The primary outcome is the difference between the pain scores recorded by the VAS and those recorded by the HEATMAP application at predefined postoperative time points \[both measured on a scale from 1-10, with higher scores indicating greater pain\].
Secondary Outcomes
- Length of stay [days](During the hospital stay, on average 2 days)
- Pain Assessment(pre-/peri-/postoperative)
- Pain Management(pre-/peri-/postoperative)
- Secondary need of double-J catheter(up to 4 weeks postoperative)
- Procedure related readmissions(up to 4 weeks postoperative)
- Procedure related reoperations(up to 4 weeks postoperative)
- Comprehensive Complication Index(up to 4 weeks postoperative)
Investigators
Lukas J Hefermehl
Principal Investigator
Kantonsspital Baden