跳至主要内容
临床试验/NCT02372747
NCT02372747已完成不适用

Comparison of Delta-Shaped and Billroth II for Intracorporeal Anastomosis After Totally Laparoscopic Distal Gastrectomy for Gastric Cancer

The First Hospital of Jilin University0 个研究点目标入组 78 人开始时间: 2012年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
78
主要终点
Stage distribution

研究概览

简要总结

To compare the safety and feasibility of Delta-shaped anastomosis and Billroth II anastomosis after totally laparoscopic distal gastrectomy for gastric cancer(TLDG).

详细描述

Methods: 78 consecutive patients who underwent TLDG in First Hospital of Jilin University between October 2012 and December 2014 were enrolled in this study . All patients were divided randomly into two groups:Delta-shaped anastomosis group (DS group) and Billroth II anastomosis group (B-II group), and the patients in DS group underwent Delta-shaped anastomosis after TLDG, and the patients in B-II group underwent Billroth-II anastomosis after TLDG.Outcome measures,resected margin,operative time,anastomosis time,number of stapler cartridges used,length of the incision,the time of first flatus and liquid diet,hospital stay and postoperative morbidity are compared between the two groups.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

性别
All
接受健康志愿者

入选标准

  • carcinoma located in the lower 1/3 of gastric body or antrum of stomach
  • diagnosed by endoscopy ,endoscopic ultrasonography and abdominal CT scan
  • diameter of the tumor <3cm
  • no pyloric obstruction

排除标准

  • diameter of the tumor ≥3cm
  • associated with obstruction, bleeding, emergency surgery or surgical intervention
  • tumor with extensive metastasis
  • patient had previously undergone gastrostomy

结局指标

主要结局

Stage distribution

时间窗: up to 7 days after the operation

Anastomosis time

时间窗: up to 7 days after the operation

The number of stapler cartridges used

时间窗: up to 7 days after the operation

Length of the incision

时间窗: up to 7 days after the operation

Resected margin

时间窗: up to 7 days after the operation

Median estimated blood loss

时间窗: up to 7 days after the operation

Operative time

时间窗: up to 7 days after the operation

Red blood cell transfusion

时间窗: up to 7 days after the operation

次要结局

  • Postoperative complication(up to 30 days after the operation)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Quan Wang

Deputy Director of General Surgery

The First Hospital of Jilin University

相似试验