ROBOtic-assisted Versus Conventional Open Partial Nephrectomy: a Single-center, Open-label, Randomized Controlled Feasibility Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Recruitment rate
研究概览
简要总结
ROBOCOP is an open-label, randomized controlled feasibility trial comparing robotic-assisted and open partial nephrectomy in preparation for a confirmative phase III randomized controlled trial.
详细描述
Surgical excision is the gold standard for the treatment for localized kidney cancer. An organ-preserving procedure should be carried out whenever possible in order to maintain kidney function. Partial nephrectomy can be performed through the conventional open technique as well as through a robotic-assisted approach. Although both methods belong to the standard care, there is still no published data from randomized controlled trials in the scientific literature comparing them. The ROBOCOP-trial is designed as a single-center comparison of the two surgical approaches in preparation for a phase III study. 50 patients are to be included in the trial within a period of 15 months. The primary endpoint is feasibility of patient recruitment. In addition, potential primary outcomes for a confirmative trial such as perioperative complications, quality of life, inflammatory response, survival and ergonomic aspects for the operating surgeons will be investigated.
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
- •scheduled for elective partial nephrectomy for renal neoplasms
- •Patient must be at least 18 years old and capable to consent
- •abdominal MRI or CT scan
- •curative-intent surgery
- •robotic-assisted and open approach for surgery are both feasible
- •ability of patient to understand the goal, consequences and alternatives of participation in the trial
- •written informed consent
排除标准
- •patients with solitary kidney
- •multiple kidney tumors
- •emergency intervention, for example because of bleeding or perforation
- •2nd malignancy that will make PN needless, this does not include secondary malignancies which are under curative treatment or cases in which death from RCC is more likely
- •patient belongs to a vulnerable patient group
- •simultaneous 2nd surgery
研究组 & 干预措施
Robotic-assisted partial nephrectomy
Partial nephrectomy will be performed using a robotic-assisted laparoscopic approach.
干预措施: Partial nephrectomy (Procedure)
Open partial nephrectomy
Partial nephrectomy will be performed using an open retroperitoneal approach.
干预措施: Partial nephrectomy (Procedure)
结局指标
主要结局
Recruitment rate
时间窗: 15 months
Proportion of randomized patients in relation to the eligible ones.
次要结局
- Inflammatory response(throughout patient´s hospital stay, on average 6 days)
- Perioperative complications(throughout patient´s hospital stay, on average 6 days)
- Length of hospital stay(throughout patient´s hospital stay, on average 6 days)
- Postoperative self-reported quality of life(90 days)
- Conversion to radical nephrectomy(Immediately after surgery)
- Case cost(90 days)
- Self-reported quality of life in patients with kidney disease(90 days)
- Resection status(up to 5 days)
- Use of analgesia(throughout patient´s hospital stay, on average 6 days)
- Blood loss(Immediately after surgery)
- Conversion to open surgery(Immediately after surgery)
- Kidney function - creatinine(90 days)
- Trifecta outcomes of partial nephrectomy(90 days)
- Postoperative complications(90 days)
- Kidney function - GFR(90 days)
- Self-reported generic health status(90 days)
- Self-reported quality of life assessment of cancer patients(90 days)
- Self-assessment of depression in patients ≥ 65 years old(90 days)
- Self-evaluation of cancer disease´s influence on elderly patients´ life(90 days)
- Self-assessment of comorbidity in elderly patients(90 days)
- Operative time(Immediately after surgery)
- Inflammatory response - leucocytes(throughout patient´s hospital stay, on average 6 days)
- Inflammatory response - C-reactive protein(throughout patient´s hospital stay, on average 6 days)
- Surgical ergonomics(During surgery)
- Surgical ergonomics(Immediately after surgery)
研究者
Karl-Friedrich Kowalewski
Principal Investigator
Universitätsmedizin Mannheim