跳至主要内容
临床试验/NCT03727126
NCT03727126Unknown不适用

Robotic Versus Thoracolaparoscopic Esophagectomy for Carcinoma Esophagus: a Prospective Comparative Study

GEM Hospital & Research Center3 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年11月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
3
主要终点
Lymph node yield

研究概览

简要总结

Esophageal cancer is a debilitating condition. The treatment involved is complex requiring a combination of chemotherapy and surgery in most cases. Complete removal of the tumor and the adjacent lymph nodes is of utmost importance in improving the survival. Lymph node yield following surgery helps in proper staging of the disease and is an important prognosticating variable. It is hypothesized that the lymph node yield following robotic esophagectomy is higher than that following thoracolaparoscopic esophagectomy. The study aims to compare the short term oncological outcomes following robotic esophagectomy and thoracolaparoscopic esophagectomy for carcinoma esophagus.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Resectable esophageal carcinoma, either squamous cell carcinoma or adenocarcinoma in the middle or lower part the esophagus

排除标准

  • American Society of Anesthesiologists (ASA) class 4 and above
  • Esophagectomy for other non-malignant conditions

结局指标

主要结局

Lymph node yield

时间窗: 7 days after Index Surgery

Total number of lymph nodes harvested

次要结局

  • Surgical margin status(7 days after Index Surgery)
  • Hospital stay(During index admission or re admission within 30 days)
  • Mortality(During index admission or within 90 days following surgery)
  • ICU stay(During index admission or within 30 days after surgery)
  • Complications(Up to 90 days after surgery)
  • Duration of surgery(1 day after surgery)
  • Blood loss(During surgery and up to 24 hours after index surgery)
  • Conversion rate(1 day after surgery)

研究者

发起方
GEM Hospital & Research Center
申办方类型
Other
责任方
Sponsor

研究点 (3)

Loading locations...

相似试验