Partial nephrectomy Surgery
Conditions
Interventions
We propose to use virtual 3D models generated from the CT scan to improve surgical planning for complex kidney tumours.
The trial will recruit patients selected for robotic-assisted re
Sponsors
Innersight Labs Ltd
King's College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or above. 2. Agreement at Multidisciplinary team meeting that this patient could undergo robotic-assisted partial nephrectomy. 3. Willing and able to provide written informed consent. 4. RENAL score (tumour complexity) >= 8. 5. Received contrast enhanced abdominal preoperative CT scan.
Exclusion criteria
Exclusion criteria: 1. Do not consent for robotic assisted partial nephrectomy; 2. Chose to have treatment outside one of the NHS trial sites. 3. Participation in other clinical studies that would potentially confound this study; 4. Have a horseshoe, a solitary kidney or bilateral kidney tumours; 5. Lack of willingness to allow personal medical imaging data to be used for generating a 3D model;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Operating time measured using total console time (minutes) taken from patient notes recorded after surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Hilum preparation time (minutes) measured using a timer recorded during surgery. 2. Tumor preparation time (minutes) measured using a timer recorded during surgery. 3. Tumor resection time (minutes) measured using a timer recorded during surgery. 4. Hilar clamping technique (global ischemia, selective ischemia, clampless, ice cooling) recorded during surgery. 5. Opened collecting system (yes, no) recorded during surgery. 6. Conversion to radical nephrectomy (yes/no) recorded during surgery. 7. Conversion to open surgery (yes/no) recorded during surgery. 8. Clamp time (minutes) measured using a timer recorded during surgery. 9. Experience level of surgeon measured using a questionnaire recorded after surgery. 10. Blood loss (ml) taken from patient notes recorded after surgery. 11. Total Operative time (mins) taken from patient notes recorded after surgery. 11. Length of stay (days) taken from patient notes recorded 4 weeks after surgery. 12. Margin status on histology (positive/negative) taken from patient notes recorded 4 weeks after surgery. 13. Pre/Post-operative eGFR (ml/min) taken from patient notes recorded at pre-operative assessment, 1 day after surgery, 4 weeks after surgery. 14. Pre/Post-operative creatinine (micromoles/L) taken from patient notes recorded at pre-operative assessment, 1 day after surgery, 4 weeks after surgery. 15. Pre/Post-operative Hemoglobin (g/dL) taken from patient notes recorded at pre-operative assessment, 1 day after surgery, 4 weeks after surgery. 16. Complications measured using the Clavien-Dindo Score recorded 4 weeks after surgery. | — |
Countries
England, United Kingdom
Outcome results
None listed