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临床试验/NCT04039035
NCT04039035已完成不适用

Preoperative Nutritional Assessment of The Patients Undergoing Major Gastrointestinal Surgery and Their Immediate Postoperative Outcome

National Academy of Medical Sciences, Nepal1 个研究点 分布在 1 个国家目标入组 134 人开始时间: 2015年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
134
试验地点
1
主要终点
Infectious and noninfectious complication

研究概览

简要总结

It was a prospective observational study, where preoperative nutritional status and early postoperative complications <30 days (infectious or noninfectious) were studied. The patients admitted between July 2015 to May 2017, who underwent major GI surgeries were included in the study. The study was designed to check if BMI and NRI can predict the postoperative outcomes in these patients.

详细描述

It was a prospective observational study. This study was done at NAMS, Bir Hospital, Kathmandu, Nepal between July 2015 to May 2017. All the patients who underwent major GI surgery, under general anesthesia, were included in the study. Major was defined as surgery involving >2hrs and excluded were an emergency major operation, gallstone disease operations, patients with cough, fever, and chest infections respectively. The sample size was calculated using the formula z2pq/d2. Twice the number of sample calculated was taken into consideration and the maximum tolerable error was taken as 5%. BMI and NRI were two independent categorical variables. The dependent variables were the postoperative outcome in terms of infectious and noninfectious complications. All the preoperative parameters were of the patients were recorded. The immediate postoperative complications were documented and categorized as infectious and noninfectious complications.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
35 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All the patients who underwent major GI surgery, under general anesthesia, were included in the study. Major was defined as surgery involving >2hrs and

排除标准

  • Excluded were an emergency major operation, gallstone disease operations, patients with cough, fever, and chest infections respectively

结局指标

主要结局

Infectious and noninfectious complication

时间窗: 3 years

Correlation between NRI/BMI and postoperative complications (infectious and noninfectious). The NRI is calculated using the formula: NRI = (15.9 × serum albumin g/L) + (41.7 × current weight/usual weight). The usual weight was defined as the stable weight 6 months before the illness in Kilograms. NRI \> 100 indicated that the patient is not malnourished, while 97.5-100 indicated mild malnourishment, 83.5-97.5 indicated moderate malnourishment and \<83.5 indicated severe malnourishment respectively. And BMI is defined as the weight in Kilograms divided by the square of height in Meters.

次要结局

  • Length of hospital stay and cost(3 years)

研究者

发起方
National Academy of Medical Sciences, Nepal
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Nabin Pokharel

Assistant Professor/ Senior Medical Officer

National Academy of Medical Sciences, Nepal

研究点 (1)

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