Ergonomical Assessment of Three-Dimensional Versus Two-Dimensional Thoracoscopic Lobectomy for Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- a difference ≥10% in the score calculated for the maneuvring ergonomical domain.
研究概览
简要总结
Video-assisted thoracic surgery (VATS) pulmonary lobectomy is currently widely employed as the first treatment option for surgical management of early stage (stage I-II) non-small-cell-lung-cancer (NSCLC).
Thanks to recent technological advances in high definition display systems, three dimensional VATS (3D) has been developed in an attempt of overcoming some optical limits of two dimensional (2D) VATS.
In this single center randomized trial our aim is to comparatively assess ergonomics of 3D versus 2D VATS lobectomy for early stage NSCLC.
详细描述
Video-assisted thoracic surgery (VATS) is widely employed for pulmonary lobectomy in early stage non-small-cell-lung-cancer (NSCLC). Indeed, VATS is thought to represent an optimal minimally invasive surgical option which is deemed superior to conventional thoracotomy since it enables smaller incisions with no rib spreading thus minimizing both postoperative pain and hospital stay.
For over than three decades, several thoracic surgeons adopted VATS for anatomical lung resection using two-dimensional (2D) display systems. However, a 2D image lacks depth of perception which may negatively affect surgical manoeuvring.
Three dimensional (3D) display systems for VATS can offer superior magnified vision of the surgical field and better perception of depth during surgical manoeuvring potentially shortening learning curve, which may thus overcome some optical limitations of 2D systems.
In this single center randomized trial our aim is to comparatively assess ergonomics of 3D versus 2D VATS lobectomy for early stage (stage I-II) NSCLC. For this purpose we compared three ergonomical domains: exposure, instrumentation and maneuvering with the aid of a scoring scale entailing analysis of 5 main technical steps: vein, artery bronchus, lymph node and fissure score.
The evaluation process of the five surgical steps was carried out by 4 thoracic surgeons who individually scored all recorded operations.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical NSCLC early stage (stage I-II).
- •Both forced expiratory volume in one second (FEV1) and diffusion capacity of carbon monoxide (DLCO)>60%
- •Both predicted postoperative (PPO) FEV1 and PPO DLCO >35%
- •American Society of Anesthesia (ASA) score<=2
- •Body mass index (BMI) >18 <28
排除标准
- •Clinical NSCLC stage> II
- •History of Neoadjuvant chemotherapy or radiotherapy
- •Radiologic evidence of extensive pleural adhesions.
- •Age <18 or >80 years.
- •Patients with previous pleurodesis or thoracotomy in the affected hemithorax.
- •Patients who will undergo surgical lung resection other than lobectomy.
- •Patients with severe comorbidity contraindicating lobectomy.
- •Patients refusal or noncompliance to general surgery and one-lung ventilation.
结局指标
主要结局
a difference ≥10% in the score calculated for the maneuvring ergonomical domain.
时间窗: one week after surgery
3 ergonomical domains: exposure, instrumentation and maneuvering are assessed by 4 thoracic surgeons using a new scoring scale (score range 1, unsatisfactory to 3 excellent). Primary outcome is a difference ≥10% (sd=0.3) in at least one of the evaluated domains.
次要结局
- intraoperative bleeding(intraoperative)
- postoperative drainage volume(two weeks after surgery)
- hospital stay(30 days after surgery)
- complications(30 days after surgery)
- Operative time(during surgery)
- surgical mortality(90 days after surgery)
- a difference ≥10% in the score calculated for the instrumentation ergonomical domain.(one week after surgery)
- a difference ≥10% in the score calculated for the exposure ergonomical domain.(one week after surgery)
研究者
Eugenio Pompeo
Principal Investigator
University of Rome Tor Vergata