Health TrialsbyHealthPanel

Evaluating Postoperative Pain After Ureterorenoscopy.

ConditionUreteral Stones
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLukas J Hefermehl

About this trial

Comparison of routine postoperative stenting versus no stenting after ureterorenoscopy for ureteral stones to assess the necessity and impact on complication risk.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 years or older

Patients with ureteral stones scheduled for ureteroscopy (URS) and stone removal

Previous pre-stenting

Informed Consent as documented

Disqualifiers

Complex ureteral conditions (e.g., known ureteral strictures)

Impacted stones

Solitary kidney

Patients with significant renal stones (>3mm)

Trial design

Design model

Parallel

Treatments tested in this trial

  • No Double-J catheter insertion

    Other intervention

    Ureterorenoscopy without consecutive DJ-stent insertion.

  • Double-J catheter

    Procedure/Surgery

    Transurethral catheter insertion

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: No-Stent GroupActive comparator 1 intervention
Group B: Stent GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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 \[both measured on a scale from 1-10, with higher scores indicating greater pain\].

Time frame
up to 4 weeks postoperative

Secondary outcomes

1

Length of stay [days]

Time from surgery to discharge in days \[d\]

Time frame
During the hospital stay, on average 2 days
2

Pain Assessment

Assessment of pain level via Visual Analogue Scale (VAS), scale \[1-10, higher scores indicates greater pain\]

Time frame
pre-/peri-/postoperative
3

Pain Management

Documentation of pain management \[according to the WHO Analgesic Ladder, 1-4, higher scores mean more intense pain treatment\]

Time frame
pre-/peri-/postoperative
4

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 \[yes/no\]

Time frame
up to 4 weeks postoperative

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Lukas J Hefermehl

Lead sponsor

Kantonsspital Baden

Sponsor institution

Kantonsspital Baden

Collaborator

Source ClinicalTrials.gov
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