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| Name | Class |
|---|---|
| Kantonsspital Baden | OTHER |
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Comparison of routine postoperative stenting versus no stenting after ureterorenoscopy for ureteral stones to assess the necessity and impact on complication risk.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No-Stent Group | Active Comparator | No postoperative double-J catheter following ureterorenoscopy. |
|
| Stent Group | Active Comparator | Routine postoperative double-J catheter insertion following ureterorenoscopy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Double-J catheter insertion | Other | Ureterorenoscopy without consecutive DJ-stent insertion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain assessment | 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]. | up to 4 weeks postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Length of stay [days] | Time from surgery to discharge in days [d] | During the hospital stay, on average 2 days |
| Pain Assessment | Assessment of pain level via Visual Analogue Scale (VAS), scale [1-10, higher scores indicates greater pain] |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lukas John Hefermehl, PD Dr. med. | Kantonsspital Baden AG | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kantonsspital Baden AG | Recruiting | Baden | 5404 | Switzerland |
The data that will be recorded in this study will be available on reasonable request from the PI
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| Double-J catheter | Procedure | Transurethral catheter insertion |
|
| pre-/peri-/postoperative |
| Pain Management | Documentation of pain management [according to the WHO Analgesic Ladder, 1-4, higher scores mean more intense pain treatment] | pre-/peri-/postoperative |
| Secondary need of double-J catheter | (Please note, this applies only for patients that where in the intervention group.) Patient received a double-J catheter, binary [yes/no] | up to 4 weeks postoperative |
| Procedure related readmissions | Readmission that can be linked to the URS, binary [Yes/No] | up to 4 weeks postoperative |
| Procedure related reoperations | Reoperation that can be linked to the URS, binary [Yes/No] | up to 4 weeks postoperative |
| Comprehensive Complication Index | Any complication that occurred within 30 days post surgery, Scale [from 0 (no complication) to 100 (death)] | up to 4 weeks postoperative |