Virtual Interactive 3D Modelling to Improve Outcomes in Robotic-Assisted Partial Nephrectomy - A Multicentre, Randomised, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 370
- 试验地点
- 10
- 主要终点
- Primary endpoint is the console operation time measured intra-op.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Partial kidney nephrectomy with aid of 3D model
The patient information (before intervention) and the surgery (partial nephrectomy) will be performed with the aid of 3D modelling of the kidney.
干预措施: partial kidney nephrectomy (Procedure)
Partial kidney nephrectomy with aid of 3D model
The patient information (before intervention) and the surgery (partial nephrectomy) will be performed with the aid of 3D modelling of the kidney.
干预措施: DaVinci Robot (Device)
Partial kidney nephrectomy with aid of 3D model
The patient information (before intervention) and the surgery (partial nephrectomy) will be performed with the aid of 3D modelling of the kidney.
干预措施: Innersight 3D software (Device)
Partial kidney nephrectomy with aid of 2D model
The patient information (before intervention) and the surgery (partial nephrectomy) will be performed with the aid of 2D modelling of the kidney.
干预措施: partial kidney nephrectomy (Procedure)
Partial kidney nephrectomy with aid of 2D model
The patient information (before intervention) and the surgery (partial nephrectomy) will be performed with the aid of 2D modelling of the kidney.
干预措施: DaVinci Robot (Device)
结局指标
主要结局
Primary endpoint is the console operation time measured intra-op.
时间窗: 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.
次要结局
- Peri-operative - Warm ischaemia time (WIT)(Visit 2: during operation)
- Peri-operative - Surgeon confidence level(Visit 2: during operation)
- Post-operative - eGFR(from the end of operation until discharge (up to 6 days) and at Visit 4: 6 month after operation)
- Pre-operative - APAIS(Visit 1: pre-operative (between surgery consent and operation - latest 7 days after surgery consent))
- Peri-operative - Number of transfusions(Visit 2: during operation)
- Post-operative - Creatinine(from the end of operation until discharge (up to 6 days) and at Visit 4: 6 month after operation)
- Pre-operative - STOA(Visit 1: pre-operative (between surgery consent and operation - latest 7 days after surgery consent))
- Pre-operative - NRS(Visit 1: pre-operative (between surgery consent and operation - latest 7 days after surgery consent))
- Pre-operative - Patient satisfaction questionnaire(Visit 1: pre-operative (between surgery consent and operation - latest 7 days after surgery consent))
- Peri-operative - Hilar clamping technique(Visit 2: during operation)
- Peri-operative - Number of conversions to open surgery(Visit 2: during operation)
- Peri-operative - Number of conversions to radical nephrectomy(Visit 2: during operation)
- Peri-operative - Total Operative time(Visit 2: during operation)
- Pre-operative - PRA-D(Visit 1: pre-operative (between surgery consent and operation - latest 7 days after surgery consent))
- Peri-operative - Estimated blood loss(Visit 2: during operation)
- Post-operative - Positive margin status(Visit 3: after operation up to 6 weeks)
- 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))
研究者
Jens-Uwe Stolzenburg
Prof. Dr.
University of Leipzig