None listed
Conditions
Brief summary
This study aims to evaluate the use of smaller-calibre endoscopic equipment during routine ureteroscopy and laser treatment for kidney and ureteric stones. Smaller instruments may allow the procedure to be completed more easily and with higher rates of success. The main aim is to assess whether these procedures can be completed successfully without use of pre-operative ureteric stents, and potentially also post-operatively, while monitoring procedural safety and short-term complication outcomes.
Interventions
This study involves adult patients with renal or ureteric calculi undergoing endoscopic management for stone treatment. Renal and ureteric stone disease may present with pain, obstruction, infection, haematuria, or incidental radiological detection. The exposure under evaluation is ureteroscopy and laser lithotripsy performed using smaller calibre endoscopic equipment, specifically a 6.3 Fr flexible ureteroscope, with use of a ureteric access sheath where it can be safely and successfully passed. The calibre of the ureteric access sheath will reflect the smallest compatible device available at the time of the procedure. Participants will undergo routine clinical care only. No additional invasive procedures or biological samples will be required. Data collected will include operative details and post-operative outcomes as part of standard documentation. Participants will be contacted once at approximately 7 days post-operatively to complete patient-reported outcome measures. These will include a Numerical Rating Scale (0–10) for pain (approximately 1–2 minutes), the number of days requiring analgesia (0–7 days), the highest level of analgesia required (paracetamol, NSAID, opioid), presence of dysuria (yes/no), presence of visible haematuria (yes/no), any unplanned healthcare contact (GP visit, ED presentation, or hospital readmission), and days taken to return to normal activity or work. Participants who receive a post-operative ureteric stent will additionally complete the Ureteral Stent Symptom Questionnaire (approximately 5–7 minutes). Total questionnaire completion time will be less than 10 minutes for unstented patients and approximately 10–15 minutes for stented patients. Follow-up for symptom assessment will occur once at 7–10 days post-operatively, consistent with routine clinical follow-up timeframes, and post-operative complication monitoring will extend to 30 days following ureteroscopy. Stent placement following ureteroscopy is determined by intra-operative findings and surgeon judgement. In this study, stenting will not be mandated and will reflect standard clinical decision-making. The study will document stent utilisation rates and associated symptom outcomes.
Sponsors
Eligibility
Inclusion criteria
1. Age 18 years and over 2. Planned for standard of care treatment of urolithiasis with laser lithotripsy
Exclusion criteria
1. Age under 18 years 2. Significant variant or altered anatomy - including urinary diversion 3. Active urinary tract infection or sepsis at the time of procedure 4. Pre-existing ureteric stricture 5. Pre-existing ureteric stent/s in-situ 6. Pregnancy