Randomised Study to Assess the Feasibility and Outcomes of Robotic Assisted Partial Nephrectomy in Low Pressure With AirSeal
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 280
- 试验地点
- 29
- 主要终点
- Intensity of post-operative pain
研究概览
简要总结
The main objective is to prospectively assess the impact of low insufflation pressure using AirSeal system (7mm Hg) during RAPN on post-operative patient pain (main location and intensity), 24 hours after surgery. The study will be conducted among 15 centers of the French research network on kidney cancer UroCCR.
详细描述
Minimally invasive route for PN is recommended to offer patients ERAS and day-case pathways leading to the best possible recovery. In this setting, pain management is crucial and every innovation supposed to offer a benefit has to be assessed. For transperitoneal laparoscopic procedures, the level and stability of the insufflation pressure will influence the quality of the pneumoperitoneum and may impact the feasibility of the surgery as well as intra and post-operative outcomes. It is universally recognized that the lower insufflation pressure, the better. However, a balance has usually to be found between technical feasibility of the surgery and lowest acceptable insufflation pressure. The AirSeal system aims to generate a stable pneumoperitoneum even in case of active gaz succion by the surgeon's assistant. The investigators then hypothesize that RAPN would be feasible and safe even in low pressure (7mm Hg) and may decrease post-operative patients' pain.
The investigators plan to describe the feasibility of Low Pressure RAPN at 7mm Hg (LP-RAPN) and assess its intra and post-operative outcomes including pain and recovery on a patient perspective. This will be achieved comparatively to RAPN performed at standard insufflation pressure of 12 mm Hg and through a single blinded randomized trial design.
The project has been developed and will be conducted within the framework of the French research network on kidney cancer UroCCR (www.uroccr.fr). INCa has been supporting this multidisciplinary network since 2011 and the web-based shared clinical and biological national database on kidney cancer UroCCR will be used.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The randomization list is drawn up by the statistician of the Center for Methodology and Data Management (USMR of the Bordeaux University Hospital) before starting the research.
The numbers of the 2 strategy groups are balanced with a 1:1 ratio. The randomization will be stratified on the study centers and a detailed description of the analgesia practices of each center will be made at the beginning of the study.
The randomization will be done when the patient is under general anesthesia. Patients will not be told which group they have been randomized to.
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
- •Male or Female aged of 18 and over
- •Planned transperitoneal RAPN for tumor with AirSeal system.
- •Affiliation to or beneficiary of the French social security
- •Patient in capacity and willing to accurately report pain-killer intakes in the first postoperative 7 days.
- •Free, informed and written consent signed by the patient and the investigating physician (at the latest on the day of inclusion and before any examination required by the research).
排除标准
- •Daily chronic pain-killers intake for another indication than the kidney tumor and intended to be maintained at the time of surgery
- •Person deprived of liberty
- •Person under trusteeship, curatorship or legal guardianship
- •Refusal of consent or participation in the UroCCR project and the P-NeLoP ancillary trial
- •Exclusion Criteria:
结局指标
主要结局
Intensity of post-operative pain
时间窗: 24 hours after surgery
intensity of pain measured by a numeric analogic scale (between 0 and 10)
次要结局
- Number of clamp procedures.(at surgery)
- Main location and intensity of post-operative pain.(6 hours and 48 hours after surgery)
- Length of surgery(up to 30 Days)
- Estimated blood loss and intra-operative transfusion(at surgery)