Kidney Tumor
Conditions
Keywords
DaVinci Surgical System, robotic-assisted partial nephrectomy, Kidney tumours
Brief summary
The primary objective is to determine if 3D modelling shortens total console operation time as a surrogate endpoint for clinical outcomes like perioperative complications and morbidity in robotic-assisted partial nephrectomy.
Detailed description
3DPN is a prospective, multicentre, randomised, controlled, two-armed, open trial to compare the 3D modelling with the 2D modelling in robotic-assisted partial nephrectomy. According to the randomisation the 3D or 2D modelling is used for patient information (before intervention) and for partial nephrectomy. A six-month follow-up visit is provided.
Interventions
PROCEDUREpartial kidney nephrectomy
surgery for partial nephrectomy
DEVICEDaVinci Robot
device to perform the surgery for partial nephrectomy (not the intervention of interest)
DEVICEInnersight 3D software
investigational product to generate the 3D model
Sponsors
University of Leipzig
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Parallel Assignment randomization to 3D or 2D modelling
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with kidney tumours ≤ 7cm and planned robotic-assisted partial nephrectomy with the DaVinci Surgical System * CT scan with contrast medium available * Age ≥ 18 years * Written informed consent
Exclusion criteria
* History of surgery on affected kidney (e.g., partial nephrectomy, pyeloplasty, kidney cyst deroofing, percutaneous nephrolitholapaxy, radiofrequency ablation) * Clinical suspicion of metastases (stage cN1/cM1) * Horseshoe kidney * Previous malignancy with ongoing or planned nephrotoxic chemotherapy * Multifocal kidney tumour * Von Hippel-Lindau syndrome and other hereditary kidney cancer syndromes * Patient is immunosuppressed (e.g., organ transplantation, leukaemia) * Tumor thrombus in Vena renalis or Vena cava inferior * Severe cognitive impairment * Pregnancy or lactation or women with desire for children * Patients under legal supervision or guardianship * Unable to give informed consent or suspected lack of compliance * Patients who decline data collection and storage for the main study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary endpoint is the console operation time measured intra-op. | intra-operative | Total console time is measured as time from starting the surgical procedure in the DaVinci console to ending the procedure in the console. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pre-operative - PRA-D | Visit 1: pre-operative (between surgery consent and operation - latest 7 days after surgery consent) | Quality of the Physician-Patient Relationship - Evaluation of the German Version of the Patient Reactions Assessment (PRA-D); fifteen items with seven expressions from "I do not agree at all" to "I agree completely" |
| Pre-operative - STOA | Visit 1: pre-operative (between surgery consent and operation - latest 7 days after surgery consent) | STATE-TRAIT-Operations-Angst (STOA) for anxiety; thirty items with four expressions from "not at all" to "very" |
| Pre-operative - APAIS | Visit 1: pre-operative (between surgery consent and operation - latest 7 days after surgery consent) | Amsterdam Preoperative Anxiety and Information Scale (APAIS) for anxiety; six items with five expressions from "Do not agree at all" to "strongly agree" |
| Pre-operative - NRS | Visit 1: pre-operative (between surgery consent and operation - latest 7 days after surgery consent) | numeric rating scale (NRS) for anxiety; numeric scale form one to ten (not afraid at all to very big anxiety) |
| Pre-operative - Patient satisfaction questionnaire | Visit 1: pre-operative (between surgery consent and operation - latest 7 days after surgery consent) | Patient satisfaction questionnaire regarding the informed consent process |
| Peri-operative - Hilar clamping technique | Visit 2: during operation | Hilar clamping technique (three levels: global ischemia, selective ischemia, clampless) |
| Peri-operative - Warm ischaemia time (WIT) | Visit 2: during operation | Warm ischaemia time (WIT) in minutes |
| Peri-operative - Estimated blood loss | Visit 2: during operation | Estimated blood loss in ml |
| Peri-operative - Number of transfusions | Visit 2: during operation | Number of transfusions |
| Peri-operative - Total Operative time | Visit 2: during operation | Total Operative time measured from incision to suture in minutes |
| Peri-operative - Number of conversions to open surgery | Visit 2: during operation | Number of conversions to open surgery |
| Peri-operative - Number of conversions to radical nephrectomy | Visit 2: during operation | Number of conversions to radical nephrectomy |
| Peri-operative - Surgeon confidence level | Visit 2: during operation | Surgeon confidence level evaluated by questionnaire survey; five questions with five expressions from "excellent" to "very bad" |
| Post-operative - Positive margin status | Visit 3: after operation up to 6 weeks | Positive margin status, range: R0, R1, R2, RX |
| Post-operative - Creatinine | from the end of operation until discharge (up to 6 days) and at Visit 4: 6 month after operation | Creatinine in µmol/l |
| Post-operative - eGFR | from the end of operation until discharge (up to 6 days) and at Visit 4: 6 month after operation | eGFR (CKD-EPI) in ml/min/1,73m² |
| Post-operative - Patient length of stay | from day of hospitalization (up to 7 days before operation) until the day of discharge (up to 6 days) | Patient length of stay in days |
Countries
Germany
Contacts
STUDY_CHAIRJens-Uwe Stolzenburg, Prof.
Leipzig University, Department of Urology
Outcome results
None listed