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

Not Applicable

Recruiting

• Conditions: Kidney Tumor

• Registration Number: NCT06056505
• Lead Sponsor: University of Leipzig

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.

Study Timeline

• Study First Submitted: 2023-06-16
• Study First Submitted QC: 2023-09-20
• Study First Posted: 2023-09-28
• Study Start: 2023-10-24
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-09
• Primary Completion: 2026-03-31
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 370

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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"
Peri-operative - Number of transfusions	Visit 2: during operation	Number of transfusions
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
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 - 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 - 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 - Total Operative time	Visit 2: during operation	Total Operative time measured from incision to suture in minutes
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"
Peri-operative - Estimated blood loss	Visit 2: during operation	Estimated blood loss in ml
Post-operative - Positive margin status	Visit 3: after operation up to 6 weeks	Positive margin status, range: R0, R1, R2, RX
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 - 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
Peri-operative - Warm ischaemia time (WIT)	Visit 2: during operation	Warm ischaemia time (WIT) in minutes
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

Trial Locations

Locations (8)

Universitätsklinikum Carl Gustav Carus Dresden, Klinik und Poliklinik für Urologie; 🇩🇪 Dresden, Saxonia, Germany

Leipzig University, Department of Urology; 🇩🇪 Leipzig, Saxonia, Germany

Sana Klinikum Borna, Klinik für Urologie; 🇩🇪 Borna, Germany

St. Antonius-Hospital Gronau, Klinik für Urologie, Kinderurologie und Urologische Onkologie; 🇩🇪 Gronau, Germany

Universitätsklinikum des Saarlandes - Homburg/Saar, Klinik für Urologie und Kinderurologie; 🇩🇪 Homburg, Germany

Universitätsklinikum Magdeburg, Klinik für Urologie, Uroonkologie, robotergestützte und fokale Therapie; 🇩🇪 Magdeburg, Germany

Universitätsmedizin Mainz, Klinik und Poliklinik für Urologie und Kinderurologie; 🇩🇪 Mainz, Germany

Universitätsmedizin Mannheim, Klinik für Urologie und Urochirurgie; 🇩🇪 Mannheim, Germany