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临床试验/NCT03658083
NCT03658083已完成不适用

Exploring Robotic-assisted Thoracic Surgery for Lung Cancer: Does Robotic-assisted Thoracic Surgery Result in Improved Functional Outcomes Compared to Thoracotomy and How do Patients Appraise the Experience of Undergoing RATS

Teesside University2 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2017年10月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
55
试验地点
2
主要终点
Change in exercise capacity assessed using the Incremental Shuttle Walk Test (ISWT)

研究概览

简要总结

Background Surgery for lung cancer can be performed using open (thoracotomy) or minimally invasive techniques (Video Assisted Thoracic Surgery (VATS)). Despite being associated with fewer postoperative complications (PPCs) VATS is difficult to perform and is only used by 20-44% of thoracic surgeons in the UK. Robotic-Assisted Thoracic Surgery (RATS) maybe a more attractive minimally invasive approach. To date, no studies have explored the impact of RATS on exercise capacity or physical activity and although 1 study has looked at Heath Related Quality of Life (HRQOL) post-RATS compared to an open technique indicators of surgical technique were not controlled for. Furthermore, investigators have little understanding of patients' experience of RATS.

Aims

  1. To examine the variability of change in exercise capacity and health-related quality of life (HRQOL) between those who receive thoracotomy V RATS.
  2. To compare the difference in post-operative physical activity (step and activity count), across 7 days, in those who receive thoracotomy V RATS.
  3. To explore the manner in which patients appraise their experience of undergoing RATS.

Methods:

A mixed-method, multi-center study will be undertaken, utilizing a prospective quasi-experimental study design and an interpretive phenomenological approach. 80 individuals, referred for a lung lobectomy with a primary or secondary diagnosis of lung cancer, will complete outcomes assessed at 4 time-points. The Incremental Shuttle Walk Test (ISWT) and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ C30) and the EORTC Lung Cancer module (EORTC QLQ LC13) will be completed at: baseline, 3-6 days post surgery, 6-weeks post-surgery and at 3-month follow up. Patients will wear an activity monitor immediately post-surgery until 1-week post-discharge. Step and activity counts will be recorded. In-depth interviews will be conducted with up to 15 patients who underwent RATS to explore the manner in which patients appraise their experience of RATS.

详细描述

Lung cancer is the second most common cause of cancer in the UK and the most common cause of cancer death. Surgery is currently the most effective treatment for curing lung cancer and it can be performed using open (thoracotomy) or minimally invasive techniques (Video Assisted Thoracic Surgery (VATS)). Despite VATS being associated with fewer postoperative complications (PPCs), faster recovery and better survival at 4 years compared to thoracotomy it is only used by 20-44% of thoracic surgeons in the UK and just 5% of surgeons in Europe report using minimally invasive techniques for lung resection. Rigid, restrictive instruments and suboptimal vision means a steep learning curve is necessary to conduct VATS successfully. RATS maybe a more attractive minimally invasive approach as it offers 3DHD vision, a 360 degree view of the chest, and a fully articulated arm. JCUH and the Barts Hospital are two of the few centers in the UK performing RATS.

Research on RATS has been largely limited to single retrospective case series reports focusing on safety (PPCs and mortality) and cost effectiveness outcomes. Little research has been conducted exploring the effect of RATS on patient-centered outcomes that are also important quality measures.

To date, no studies have explored the impact of RATS on exercise capacity, yet investigators know that individuals who undergo a thoracotomy have a 16% reduction in exercise capacity at 6 months follow up. Exercise capacity has been shown to be an important predictor for long-term prognosis and length of stay following thoracic surgery, which can have substantial implications for cost. Furthermore, percentage VO2 max has been shown to be the best predictor of PPCs within 30 days of undergoing a lung resection (predictive value 85.5%), which is an important indicator of patient safety.

Two studies have looked at HRQOL post-RATS and compared it to an open technique. Balduyck and colleagues reported that whilst significant reductions from baseline were seen 1 month post-surgery in those who underwent an open procedure (sternotomy), HRQOL had returned to baseline values by 1 month post-surgery in those who underwent RATS. However, indicators of whether individuals received RATS or an open procedure were not controlled for which is likely to be important as individuals who have large tumors are not eligible to receive RATS. Instead RATS is usually assigned to older, frailer individuals. The second study did conduct between-groups comparisons between those who underwent a robotic lobectomy V those who received an open rib and nerve sparing lobectomy. The mental-component of the SF-12 was significantly higher in the robot group at 3 weeks post-surgery, indicating better mental quality of life, although there were no significant between-group differences detected for the physical-component. By 4 months follow up neither the mental nor the physical HRQOL scores differed between the two groups. The SF-12 in a general measure of health status and to date the impact of open surgery V RATS on disease-specific HRQOL has not been explored.

Physical activity is associated with improved HRQOL in patients with lung cancer and increased survival post-diagnosis of cancer. However, 2 months following a lung resection, performed via a thoracotomy or VATS, physical activity levels were still reduced. Unfortunately comparisons between surgical groups were not possible in this study due to the small number of patients who underwent VATS (14), therefore postoperative physical activity in those who have undergone thoracotomy compared to minimally invasive surgery is still unknown.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Individuals referred for a lung resection via thoracotomy or RATS with a primary or secondary diagnosis of lung cancer

排除标准

  • Tumor >7cm

结局指标

主要结局

Change in exercise capacity assessed using the Incremental Shuttle Walk Test (ISWT)

时间窗: Baseline to 4-6 weeks post-surgery (visit 2)

Distance walked in meters

次要结局

  • Change in physical activity assessed using an Activity Monitor(Immediately post-surgery to 1-week post-discharge)
  • Change in disease-specific health related quality of lifeassessed using self-reported questionnaire(Baseline to 3 month post-surgery (visit 3))
  • Change in disease-specific health related quality of life assess using a self-reported questionnaire(Baseline to 3-6 days post-surgery (visit 1))
  • Change in health related quality of life assessed using self-reported questionnaire(Baseline to 3 month post-surgery (visit 3))
  • Change in exercise capacity assessed using the Incremental Shuttle Walk Test (ISWT)(Baseline to 3 months post-surgery (visit 3))
  • Change in Health related quality of life assessed using self-reported questionnaire(Baseline to 4-6 weeks post-surgery (visit 2))
  • Change in disease-specific health related quality of life assessed using self-reported questionnaire(Baseline to 4-6 weeks post-surgery (visit 2))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Samantha Harrison

Reader in research

Teesside University

研究点 (2)

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