跳至主要内容
临床试验/NCT02365896
NCT02365896Unknown不适用

Comparison of Short Term Outcomes Between Totally Laparoscopic and Laparoscopy-Assisted Distal Gastrectomy With Billroth-II Reconstruction and D2 Lymphadenectomy for Locally Advanced Gastric Cancer

Fujian Cancer Hospital0 个研究点目标入组 176 人开始时间: 2015年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
176
主要终点
postoperative early anastomotic morbidity

研究概览

简要总结

Prospective Randomized Controlled Multicenter Clinical Trial for Comparison of Safety Between Totally Laparoscopic Distal Gastrectomy(TLDG) and Laparoscopy-Assisted Distal Gastrectomy(LADG) With Billroth-II Reconstruction and D2 Lymphadenectomy for Locally Advanced Gastric Cancer

研究设计

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

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •The diagnosis of gastric cancer was confirmed by pathological examination
  • •Preoperative staging as cT2-4aN0-3M0 according to AJCC-7th
  • •No accompany with another cancer
  • •ASA I-III
  • •Agreement

排除标准

  • •Pregnant or suckling period
  • •Patients with a history of preoperative chemoradiotherapy
  • •Patients with unable to finish D2 lymphadenectomy or R0 resection
  • •Laparoscopic surgery contraindications
  • •Serious organ disfunction
  • •Accompany with serious mental disease
  • •Continuous treatment with steroid in 1 month
  • •Disagreement

研究组 & 干预措施

TLDG or LADG

Other

To complete the distal gastrectomy with Billroth-II reconstruction and D2 lymphadenectomy for locally advanced gastric cancer with TLDG or LADG

干预措施: TLDG or LADG (Procedure)

结局指标

主要结局

postoperative early anastomotic morbidity

时间窗: 30 days

次要结局

  • Pain score(10 days)
  • Quality of life(30 days)
  • Flatus time(7 days)
  • Postoperative hospital stay(30 days)
  • Postoperative inflammation response(10 days)
  • Nutrition(30 days)

研究者

申办方类型
Other Gov
责任方
Sponsor

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