Implementing Enhanced Recovery After Surgery (ERAS) Protocol in Patients Undergoing Minimal Invasive Esophagectomy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Enhanced recovery after surgery (ERAS)
研究概览
简要总结
Detect impact of enhanced recovery after surgery (ERAS) on the outcomes of oesophageal surgery .
详细描述
esophagectomy for both malignant and benign disease has been identified as a particularly complex surgical procedure due to documented high levels of peri-operative morbidity and mortality.
A comprehensive review of complications associated with the esophagectomies performed in high-volume esophageal units utilizing a standardized format for documenting complications and quality measures has confirmed an overall complication rate of 59 % with 17.2% of patients sustaining complications of IIIb or greater utilizing the Clavien-Dindo severity grading system. post-operative complications include high rate of anastomotic leakage , pulmonary infection ,thoracic duct injury , voice changes , breathlessness ,long hospital stay.
These outcomes accentuate the need for providing an enhanced recovery after surgery standardized format for esophagectomy which can be routinely applied and audited to improve international outcomes. though ERAS lacking randomized control trials
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •first detected and endoscopically confirmed esophageal cancer; 2)preoperative evaluation showed no distant metastases and suitable for MIE; 3preoperative clinical stage of I to III
排除标准
- •patients had a history of thoracic or abdominal surgery; 2)patients were IV to VI in the American Society of Anesthesiologists (ASA) physical status classification system; 3)patients had other malignancies; 4)patients had missing clinical data
研究组 & 干预措施
Conventional group
patients of minimally invasive esophagectomy with standard of care approaches
干预措施: standard of care approaches in minimal invasive esophagectomy (Other)
ERAS group
patients of minimally invasive esophagectomy with enhanced recovery after surgery protocol
干预措施: Enhanced Recovery After Surgery (ERAS) protocol in minimal invasive esophagectomy (Other)
结局指标
主要结局
Enhanced recovery after surgery (ERAS)
时间窗: average 2 years
Detect impact of enhanced recovery after surgery on the outcomes of oesophageal surgery concerning 1. time to out-of-bed activity 2. time to first flatus 3. time to liquid diet 4. postoperative hospital stay 5. ICU length of stay 6. ICU length of stay 7. in-hospital mortality 8. incidence of various postoperative complications
次要结局
- Enhanced recovery after surgery (ERAS)(average 2 years)
研究者
Khaled Hassaan Mohamed Hussein
assistant lecturer
Assiut University