NCT02085031Unknown2 期
Randomized Controlled Trial on Surgical Safety of Intracorporeal Versus Extracorporeal Roux-en-Y Esophagojejunostomy During Laparoscopic Total Gastrectomy for Gastric Cancer
适应症
干预措施
试验速览
- 阶段
- 2 期
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Anastomosis-related early complication rate
研究概览
简要总结
- To date, Roux-en-Y esophagojejunostomy transabdominal extracorporeally by circular stapler was the most common used method during laparoscopy-assisted total gastrectomy for gastric cancer, even though it was not totally laparoscopic surgery in which intracorporeal anastomosis should be performed.
- To gain potential clinical benefits from a smaller length of minilaparotomy and an easier anastomosis technique than extracorporeal anastomosis, intracorporeal Roux-en-Y anastomosis using a transorally inserted anvil (OrVil™) during totally laparoscopic total gastrectomy was adopted by experienced surgeons recently.
- However, the safety of intracorporeal Roux-en-Y esophagojejunostomy using a transorally inserted anvil (OrVil™) has not yet been evaluated. Thus, the study comparing the safety of intracorporeal versus extracorporeal Roux-en-Y esophagojejunostomy by circular stapler based on a well designed randomized controlled trial is needed.
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
- 19 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from over 18 to under 75 years
- •Primary gastric adenocarcinoma confirmed pathologically by endoscopic biopsy
- •Tumor located at middle or upper third of stomach while laparoscopic total gastrectomy is the planning surgery
- •Tumor invasion is less than 3cm above the esophagogastric junction
- •Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale
- •ASA (American Society of Anesthesiology) score class I, II, or III
- •Written informed consent
排除标准
- •Women during pregnancy or breast-feeding
- •Severe mental disorder
- •History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
- •Conversion to open surgery before reconstruction
研究组 & 干预措施
Intracorporeal Roux-en-Y esophagojejunostomy
Experimental
During totally laparoscopic total gastrectomy, Roux-en-Y esophagojejunostomy intracorporeally using a transorally inserted anvil (OrVil™) will be performed for the patients assigned to this arm.
干预措施: Intracorporeal Roux-en-Y esophagojejunostomy (Procedure)
Extracorporeal Roux-en-Y esophagojejunostomy
Active Comparator
During laparoscopic total gastrectomy, Roux-en-Y esophagojejunostomy extracorporeally using a transabdominally inserted anvil will be performed for the patients assigned to this arm.
干预措施: Extracorporeal Roux-en-Y esophagojejunostomy (Procedure)
结局指标
主要结局
Anastomosis-related early complication rate
时间窗: 30 days
Anastomotic leakage, intraluminal bleeding, or stenosis were considered as anastomosis-related early complication.
次要结局
- Reconstruction time(During operation)
- Morbidity and mortality rates(30 days)
- Postoperative recovery course(2 weeks)
- Postoperative quality of life(6 months)
研究者
Guoxin Li
M.D., Ph.D.
Nanfang Hospital, Southern Medical University
研究点 (1)
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