Clinical trial NCT06056505: Virtual Interactive 3D Modelling to Improve Outcomes in Robotic-Assisted Partial Nephrectomy
Official title: Virtual Interactive 3D Modelling to Improve Outcomes in Robotic-Assisted Partial Nephrectomy - a Multicentre, Randomised, Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Kidney Tumor
Keywords: DaVinci Surgical System
robotic-assisted partial nephrectomy
Kidney tumours
Lead sponsor: University of Leipzig
Sponsor class: OTHER
First posted: 2023-09-28
Enrollment: 370
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment randomization to 3D or 2D modelling
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Primary endpoint is the console operation time measured intra-op.
timeFrame: intra-operative
Secondary outcomes:
measure: Pre-operative - PRA-D
timeFrame: Visit 1: pre-operative (between surgery consent and operation - latest 7 days after surgery consent)
measure: Pre-operative - STOA
timeFrame: Visit 1: pre-operative (between surgery consent and operation - latest 7 days after surgery consent)
measure: Pre-operative - APAIS
timeFrame: Visit 1: pre-operative (between surgery consent and operation - latest 7 days after surgery consent)
measure: Pre-operative - NRS
timeFrame: Visit 1: pre-operative (between surgery consent and operation - latest 7 days after surgery consent)
measure: Pre-operative - Patient satisfaction questionnaire
timeFrame: Visit 1: pre-operative (between surgery consent and operation - latest 7 days after surgery consent)
measure: Peri-operative - Hilar clamping technique
timeFrame: Visit 2: during operation
measure: Peri-operative - Warm ischaemia time (WIT)
timeFrame: Visit 2: during operation
measure: Peri-operative - Estimated blood loss
timeFrame: Visit 2: during operation
measure: Peri-operative - Number of transfusions
timeFrame: Visit 2: during operation
measure: Peri-operative - Total Operative time
timeFrame: Visit 2: during operation
measure: Peri-operative - Number of conversions to open surgery
timeFrame: Visit 2: during operation
measure: Peri-operative - Number of conversions to radical nephrectomy
timeFrame: Visit 2: during operation
measure: Peri-operative - Surgeon confidence level
timeFrame: Visit 2: during operation
measure: Post-operative - Positive margin status
timeFrame: Visit 3: after operation up to 6 weeks
measure: Post-operative - Creatinine
timeFrame: from the end of operation until discharge (up to 6 days) and at Visit 4: 6 month after operation
measure: Post-operative - eGFR
timeFrame: from the end of operation until discharge (up to 6 days) and at Visit 4: 6 month after operation
measure: Post-operative - Patient length of stay
timeFrame: from day of hospitalization (up to 7 days before operation) until the day of discharge (up to 6 days)
Other outcomes:
measure: Safety endpoints - Post-op complications
timeFrame: from the end of the operation until the day of discharge (up to 6 days)
measure: Safety endpoints - Number of operation- or kidney-related readmissions
timeFrame: Visit 4: six months after operation
measure: Safety endpoints - Number of AEs, SAEs
timeFrame: Visit 4: six months after operation
Locations:
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus Dresden, Klinik und Poliklinik für Urologie
state: Saxonia
city: Leipzig
country: Germany
facility: Leipzig University, Department of Urology
state: Saxonia
city: Borna
country: Germany
facility: Sana Klinikum Borna, Klinik für Urologie
city: Gronau
country: Germany
facility: St. Antonius-Hospital Gronau, Klinik für Urologie, Kinderurologie und Urologische Onkologie
city: Homburg
country: Germany
facility: Universitätsklinikum des Saarlandes - Homburg/Saar, Klinik für Urologie und Kinderurologie
city: Magdeburg
country: Germany
facility: Universitätsklinikum Magdeburg, Klinik für Urologie, Uroonkologie, robotergestützte und fokale Therapie
city: Mainz
country: Germany
facility: Universitätsmedizin Mainz, Klinik und Poliklinik für Urologie und Kinderurologie
city: Mannheim
country: Germany
facility: Universitätsmedizin Mannheim, Klinik für Urologie und Urochirurgie
Study officials:
affiliation: Leipzig University, Department of Urology
name: Jens-Uwe Stolzenburg, Prof.
role: STUDY_CHAIR
References: