跳至主要内容
临床试验/CTRI/2009/091/000071
CTRI/2009/091/000071未知3 期

A randomised trial comparing short-term outcomes of "Uncut" Roux-en-Y gastrojejunostomy and standard Roux-en-Y gastrojejunostomy following partial gastrectomy/palliative bypass for gastric adenocarcinoma

Christian Medical College, Vellore, India.1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 待定
适应症

试验速览

阶段
3 期
发起方
入组人数
68
试验地点
1
主要终点
1. Gastric emptying time by nuclear gastric emptying scan.2. Time taken to institute solid diet

研究概览

简要总结

This study is a randomised control trail comparing the effects of 2 forms of reconstruction after partial gastrectomy for gastric cancer viz, uncut Roux-en-Y gastrojejunostomy and standard Roux-en-Y gastrojejunostomy. The study will be conducted at Christian Medical College, Vellore. Sixty-eight patients who fulfill the inclusion and exclusion criteria will be enrolled for the study. The primary outcome measures will be gastric emptying time on 15th postoperative day by nuclear scan and time taken to institute solid diet postoperatively. The secondary outcome measures will be overall mortality rate, overall morbidity rate, time taken to discontinue nasogastric intubation, pre- and post-operative Viscik grading, duration of post-operative hospital stay and need for reoperation.

研究设计

分配方式
Computer generated randomization
盲法
Open Label

入排标准

入选标准

  • Patients undergoing partial gastrectomy for gastric adenocarcinoma.
  • Age of the patient: 18 years and above.

排除标准

  • Patients who have undergone prior gastric operations or vagotomy.

结局指标

主要结局

1. Gastric emptying time by nuclear gastric emptying scan.2. Time taken to institute solid diet

时间窗: Gastric emptying time on the 15th postoperative day

次要结局

  • 1. Mortality rate.2. Overall morbidity rate.3. Time taken to discontinue nasogastric intubation.4. Viscik grading pre- and post-operatively.5. Post-operative hospital stay.6. Any reoperation.(Immediate postoperative period during the hospital stay)

研究者

发起方
Christian Medical College, Vellore, India.

研究点 (1)

Loading locations...

相似试验

A clinical trial to study the effects of two forms... | 临床试验