Ureteral Stones
Conditions
Keywords
pain app evaluation, ureterorenoscopy, double-J catheter, pain assessment
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.
Interventions
OTHERNo Double-J catheter insertion
Ureterorenoscopy without consecutive DJ-stent insertion.
PROCEDUREDouble-J catheter
Transurethral catheter insertion
Sponsors
Lukas J Hefermehl
Kantonsspital Baden
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain assessment | 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
| Measure | Time frame | Description |
|---|---|---|
| Length of stay [days] | During the hospital stay, on average 2 days | Time from surgery to discharge in days \[d\] |
| Pain Assessment | pre-/peri-/postoperative | Assessment of pain level via Visual Analogue Scale (VAS), scale \[1-10, higher scores indicates greater pain\] |
| Pain Management | pre-/peri-/postoperative | Documentation of pain management \[according to the WHO Analgesic Ladder, 1-4, higher scores mean more intense pain treatment\] |
| Secondary need of double-J catheter | up to 4 weeks postoperative | (Please note, this applies only for patients that where in the intervention group.) Patient received a double-J catheter, binary \[yes/no\] |
| Procedure related readmissions | up to 4 weeks postoperative | Readmission that can be linked to the URS, binary \[Yes/No\] |
| Procedure related reoperations | up to 4 weeks postoperative | Reoperation that can be linked to the URS, binary \[Yes/No\] |
| Comprehensive Complication Index | up to 4 weeks postoperative | Any complication that occurred within 30 days post surgery, Scale \[from 0 (no complication) to 100 (death)\] |
Countries
Switzerland
Contacts
PRINCIPAL_INVESTIGATORLukas John Hefermehl, PD Dr. med.
Kantonsspital Baden AG
Outcome results
None listed