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临床试验/NCT02694081
NCT02694081Unknown2 期

The Advantages and Disadvantages Between Uncut Roux-en-Y Reconstruction

Jilin University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年2月1日最近更新:
适应症

试验速览

阶段
2 期
发起方
入组人数
100
试验地点
1
主要终点
change of potential of hydrogen ( pH) in remnant stomach

研究概览

简要总结

The Advantages and Disadvantages Between Uncut Roux-en-Y Reconstruction and Billroth II Reconstruction After Laparoscopy-assisted Distal Gastrectomy for Gastric.

详细描述

To search which is the better reconstructions by comparing and analyzing the advantages and disadvantages between Uncut Roux-en-Y and Billroth II reconstructions after laparoscopy-assisted distal gastrectomy for gastric cancer.

Method: It's a prospective study including all patients underwent laparoscopy-assisted distal gastrectomy (LADG) in the First Hospital of Jilin University, from February 2016 to February 2017. All surgical procedures will be performed by the single surgery team, which is leaded by professor Wang Quan. The reconstruction method will be selected randomly from Uncut Roux-en-Y and Billroth II anastomosis by drawing lots preoperatively without distinct indications. Clinical data, operation data and perioperative complications and related physiological indexes of differences.

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
Single (Participant)

入排标准

年龄范围
— 至 85 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of distal gastric cancer
  • underwent laparoscopy-assisted distal gastrectomy

排除标准

  • have simultaneously other cancer
  • have severe systemic inflammatory disease ,serious illness such as diabetes, chronic lung diseases
  • have upper gastrointestinal surgery
  • can't bear the gastric tube
  • the period is too late or the tumor is too large to carry on a laparoscopy assisted radical distal gastrectomy

结局指标

主要结局

change of potential of hydrogen ( pH) in remnant stomach

时间窗: 1-6 days after surgery

In the morning of 1-6 days after operation , monitor the number of gastric juice's potential of hydrogen ( pH) value through gastric tube and write down the data. So if the data is greater than 7,the complication of bile reflux happened

The time of reconstruction during operations of Uncut Roux-en-Y Reconstruction and Billroth II Reconstruction

时间窗: within 2 hours after surgery

The time of reconstruction operation will be recorded in the operating note by nurses in minutes.

the amount of blood loss during operations of Uncut Roux-en-Y Reconstruction and Billroth II Reconstruction

时间窗: within 2 hours after surgery

During the operation the amount of blood loss will be recorded in the operating note by nurses in milliliters.

次要结局

  • the number of patients with the complication of Reflux esophagitis(6 month after surgery)
  • the number of patients with the complication of Residual food(6 month after surgery)

研究者

发起方
Jilin University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Aiping shi

Assisted Investigator

Jilin University

研究点 (1)

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