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临床试验/NCT03315195
NCT03315195Unknown不适用

A Randomized Controlled Trial Comparing Postoperative Complication Between Preoperative Oral Nutritional Supplement With Dietary Advice and Conventional Dietary Advice Alone in Patients Undergoing Elective Major Gastrointestinal Surgery

Mahidol University2 个研究点 分布在 1 个国家目标入组 268 人开始时间: 2017年11月25日最近更新:
适应症

试验速览

阶段
不适用
入组人数
268
试验地点
2
主要终点
Postoperative complications

研究概览

简要总结

Surgical outcome is associated the nutritional status of the patients. Perioperative nutritional supplement for malnutritional patient were recommended. There are several guidelines were recommended the perioperative nutrition for malnutrition patients. But in our hospital, there are no consensus guideline applied for the clinical practice. The nutritional supplement was judged by only attending physical This study was conducted to comparing the perioperative nutritional supplement with oral supplement with conventional approach with only dietary advice alone for all patients who undergoing major gastrointestinal surgery.

详细描述

The study design is a randomized controlled study. The eligible criteria is all patients who undergoing major gastrointestinal surgery including upper/lower gastrointestinal tract and hepatobiliary and pancratic surgery. After the informed consent are obtained. The patients are randomized into two group (study group and conventional group). The perioperative supplement with oral nutritional support and dietary advice were assigned in the study group. The conventional group were assigned only dietary advice. The blood test and nutritional assessment are performed by investigators in all participants. The participants were assessed two times before the operation (at first assigned and the day before the operation). The duration of nutritional supplement is at least fourteen days.The patient characteristic data, surgical intervention, and postoperative data were collected. The main outcome is the postoperative morbidity and mortality.

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
Triple (Participant, Care Provider, Investigator)

入排标准

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

入选标准

  • age > 18 year
  • undergoing major gastrointestinal surgery
  • able to take oral diet

排除标准

  • unable to take oral diet
  • Gastrointestinal tract insufficiency eg. gastrointestinal obstruction, perforation, malabsorption and peritonitis
  • allergy to milk
  • history of previous nutritional supplement from other source within one months
  • chronic kidney disease (eGFR < 60 ml/min/1.73 m2)
  • Take preoperative supplement less than 14 days
  • Refused or withdraw from the study

结局指标

主要结局

Postoperative complications

时间窗: 30 days after operation

Number of complications

次要结局

未报告次要终点

研究者

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

Narongsak Rungsakulkij

Lecturer

Mahidol University

研究点 (2)

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