Virtual Interactive 3D Modelling to Improve Outcomes in Robotic-Assisted Partial Nephrectomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Virtual Interactive 3D Modelling to Improve Outcomes in Robotic-Assisted Partial Nephrectomy - A Multicentre, Randomised, Controlled Trial

Conditions
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Kidney Tumor

Intervention / Treatment
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* Procedure: partial kidney nephrectomy
* Device: DaVinci Robot
* Device: Innersight 3D software


Participation Criteria
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Eligibility Criteria
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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) Horseshoe kidney Previous malignancy with ongoing or planned nephrotoxic chemotherapy Patient is immunosuppressed (e.g., organ transplantation, leukaemia) Tumor thrombus in Vena renalis or Vena cava inferior Existing renal insufficiency GFR < 15 ml/min/1.73m2 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 refuse to data collection and storage for the main study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel Assignment randomization to 3D or 2D modelling
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Partial kidney nephrectomy with aid of 3D model<br>The patient information (before intervention) and the surgery (partial nephrectomy) will be performed with the aid of 3D modelling of the kidney. | Procedure: partial kidney nephrectomy<br>* surgery for partial nephrectomy<br>Device: DaVinci Robot<br>* device to perform the surgery for partial nephrectomy (not the intervention of interest)<br>Device: Innersight 3D software<br>* investigational product to generate the 3D model<br>|
| Active Comparator: Partial kidney nephrectomy with aid of 2D model<br>The patient information (before intervention) and the surgery (partial nephrectomy) will be performed with the aid of 2D modelling of the kidney. | Procedure: partial kidney nephrectomy<br>* surgery for partial nephrectomy<br>Device: DaVinci Robot<br>* device to perform the surgery for partial nephrectomy (not the intervention of interest)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary endpoint is the console operation time measured intra-op. | Total console time is measured as time from starting the surgical procedure in the DaVinci console to ending the procedure in the console. | intra-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre-operative - PRA-D | 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 | Visit 1: pre-operative (between surgery consent and operation - latest 7 days after surgery consent) | 
| Pre-operative - STOA | STATE-TRAIT-Operations-Angst (STOA) for anxiety; thirty items with four expressions from not at all to very | Visit 1: pre-operative (between surgery consent and operation - latest 7 days after surgery consent) | 
| Pre-operative - APAIS | Amsterdam Preoperative Anxiety and Information Scale (APAIS) for anxiety; six items with five expressions from Do not agree at all to strongly agree | Visit 1: pre-operative (between surgery consent and operation - latest 7 days after surgery consent) | 
| Pre-operative - NRS | numeric rating scale (NRS) for anxiety; numeric scale form one to ten (not afraid at all to very big anxiety) | Visit 1: pre-operative (between surgery consent and operation - latest 7 days after surgery consent) | 
| Pre-operative - Patient satisfaction questionnaire | Patient satisfaction questionnaire regarding the informed consent process | Visit 1: pre-operative (between surgery consent and operation - latest 7 days after surgery consent) | 
| Peri-operative - Hilar clamping technique | Hilar clamping technique (three levels: global ischemia, selective ischemia, clampless) | Visit 2: during operation | 
| Peri-operative - Warm ischaemia time (WIT) | Warm ischaemia time (WIT) in minutes | Visit 2: during operation | 
| Peri-operative - Estimated blood loss | Estimated blood loss in ml | Visit 2: during operation | 
| Peri-operative - Number of transfusions | Number of transfusions | Visit 2: during operation | 
| Peri-operative - Total Operative time | Total Operative time measured from incision to suture in minutes | Visit 2: during operation | 
| Peri-operative - Number of conversions to open surgery | Number of conversions to open surgery | Visit 2: during operation | 
| Peri-operative - Number of conversions to radical nephrectomy | Number of conversions to radical nephrectomy | Visit 2: during operation | 
| Peri-operative - Surgeon confidence level | Surgeon confidence level evaluated by questionnaire survey; five questions with five expressions from excellent to very bad | Visit 2: during operation | 
| Post-operative - Positive margin status | Positive margin status, range: R0, R1, R2, RX | Visit 3: after operation up to 6 weeks | 
| Post-operative - Creatinine | Creatinine in µmol/l | from the end of operation until discharge (up to 6 days) and at Visit 4: 6 month after operation | 
| Post-operative - eGFR | eGFR (CKD-EPI) in ml/min/1,73m² | from the end of operation until discharge (up to 6 days) and at Visit 4: 6 month after operation | 
| Post-operative - Patient length of stay | Patient length of stay in days | from day of hospitalization (up to 7 days before operation) until the day of discharge (up to 6 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DaVinci Surgical System, robotic-assisted partial nephrectomy, Kidney tumours