NCT05553795终止不适用
Drainless Robot-assisted Minimally Invasive Esophagectomy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Postoperative pain
研究概览
简要总结
The aim of this study is the evaluation of two different chest drain management strategies in patients undergoing robot-assisted minimally invasive esophagectomy (RAMIE) for esophageal cancer with regard to perioperative complications until discharge.The primary objective of the study is to investigate whether the intensity of postoperative pain can be significantly reduced by avoiding thoracic drains after RAMIE. We assume that this will influence secondary endpoints such as early recovery and length of hospital stay.
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
- •Patients scheduled for elective RAMIE for esophageal cancer with intrathoracic esophagogastrostomy (Ivor-Lewis)
- •American Society of Anesthesiologists (ASA) score ≤ III
- •Eastern Cooperative of Oncology Group (ECOG) status ≤ II
- •Patient suitable for both surgical techniques
- •Ability of subject to understand character and individual consequences of the clinical trial
- •Written informed consent
排除标准
- •Open esophagectomy (either abdominal or during the thoracic part)
- •Emergency operations
- •ECOG > II
- •Chronic pain syndromes requiring routine analgesics
- •Simultaneous lung resection
- •Presence of contraindications to the use of epidural anesthesia (e.g. coagulopathies, anticoagulation or allergies)
- •Participation in an interventional trial, which interferes with the outcome
- •Impaired mental state
结局指标
主要结局
Postoperative pain
时间窗: Day 2 after surgery
Postoperative pain according to a numeric rating scale
次要结局
- Postoperative morbidity(Through hospital stay, an average of 14 days)
- Postoperative mortality(Through hospital stay, an average of 14 days)
- Mean postoperative pain(Day 4 after surgery)
- Additional analgesic drug use(Day 4 after surgery)
- Postoperative mobilization(Day 7 after surgery)
- Daily postoperative pain(Day 7 after surgery)
研究者
研究点 (2)
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