跳至主要内容
临床试验/NCT02297607
NCT02297607终止不适用

Routine Post-Operative Supplemental Nutrition: A Randomized Controlled Trial

University of Michigan2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2014年11月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
30
试验地点
2
主要终点
Quality of Life after surgery

研究概览

简要总结

Patients undergoing an esophagectomy will be randomized to receive either (1) routine post-operative tube feeding for 1 month post-operative or (2) usual practice, which is tube feeding to continue in the hospital until the patient is taking adequate nutrition by mouth at POD#8, or upon discharge.

Specific Aim 1 is to determine the occurrence of common complications and readmissions post-operatively between the two patient groups. The investigators hypothesize that routine use of tube feeding may reduce the occurrence of post-operative complications.

Specific Aim 2 is to determine if routine dietary supplementation with enteral tube affects recovery and QOL after esophagectomy. The investigators hypothesize that routine post-operative supplementation will enhance patients recovery and QOL.

For esophagectomy specifically, there is very limited literature evaluating the complication rate and QOL associated with the length of post-operative tube feeding and adequate nutritional requirements. Small randomized studies have not shown a benefit to routine tube feeding, although the numbers were very small, ranging from 12-70 per group. The investigators will randomize 200 patients for the purpose of this study.

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
None

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing an elective esophagectomy
  • Jejunal feeding tube placed at the time of surgery

排除标准

  • Emergent esophagectomy procedure
  • Inability to provide informed consent or to complete testing or data collection
  • Unwillingness to be randomized
  • Tube feeding dependent on discharge

结局指标

主要结局

Quality of Life after surgery

时间窗: 6-months post-operatively

Quality of Life will be assessed using the EORTC QLQ-30 Survey Instrument. Post-operative QOL assessment will be compared to baseline (prior to surgery) QOL assessment.

次要结局

  • Jejunostomy tube-specific complications(2-weeks, 1-month, 3-months and 6-months post-operatively)

研究者

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

Philip W. Carrott, Jr.

Assistant Professor of Thoracic Surgery, Medical School

University of Michigan

研究点 (2)

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