Prospective, Randomized, Multicentric Study On Videothoracoscopic (Vats) Vs Robotic Approach For Lobectomy Or Anatomical Segmentectomy In Patients Affected By Early Lung Cancer (ROMAN)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Postoperative complications: surgical complications, higher or equal grade II assessed by Clavien-Dindo scale, within 90 days
研究概览
简要总结
This is a prospective, randomized, multicenter study on 300 patients (150 VATS lobectomies and 150 robotic lobectomies) affected by early stage (I-II) lung cancer. The expected recruitment is one year and two year follow up. Surgeons should have a minimum of 30 major lung resections performed using one of the two techniques for participation in the study. Each participating centers should have the possibility to offer both techniques (Robotics and Vats). The primary end point is a combination of conversion and complication rate. The presence of at least one of the two events is considered a failure. Considering the rate of failure of 35% in the VATS arm, we want to see a failure rate not over 20% in the robot arm, so with a power of 80% and an alpha error of 5%, we need a total of 300 patients.
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
- •Age older than 18 years old
- •Known or suspected lung cancers
- •Patients in clinical stage T1-T2, N0-N1 candidate to surgery lobectomy or anatomical segmentectomy
- •ASA-1-2-3
排除标准
- •Clinical stage >II
- •Severe heart disease
- •Alcohol abuse
- •Renal impairment (creatinine >2.5)
- •Presence of serious comorbidities
结局指标
主要结局
Postoperative complications: surgical complications, higher or equal grade II assessed by Clavien-Dindo scale, within 90 days
时间窗: within 90 days
Intraoperative complications: conversion rate, defined as procedures that start with minimally invasive access and are converted to open surgery due to different reasons (bleeding, anatomical reasons, oncological reasons, technical reasons, other)
时间窗: date of Surgery
次要结局
- Duration of analgesic use after discharge and time to return to normal daily activity(within 90 days)
- Rate of local and distant recurrence and disease free survival(24 months)
- Patient's immune response: analysis of PCR, serum interleukins, lymphocytes subpopulations(before surgery, 2 hours after surgery and at 3rd and 14th postoperative day)
- Proportion of patients who undergo complete resection during the procedure(date of Surgery)
- Postoperative hospital stay(2 weeks)
- Number of resected lymph nodes and upstaging(date of Surgery)
- Postoperative pain: daily evaluation with visual numeric scale before and after surgery until discharge(2 weeks, 6 months and 12 months)
- Duration of surgery(date of Surgery)
- Quality of life by EORTC QOL-C30(2 weeks, 6 months and 12 months)
- Postoperative respiratory function: FEV 1, PEF and CV(6 month postoperatively)