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临床试验/NCT02050451
NCT02050451已完成不适用

A Pilot Study of Perioperative Oral Nutrition Supplementation to Improve Nutritional Status, Post-operative Complications, Length of Stay and Readmission Rates in Patients Undergoing Radical Cystectomy

Vanderbilt University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2014年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Hospital-free days (HFDs)

研究概览

简要总结

The current study is designed to assess the impact of an enriched oral nutritional shake (Ensure Plus®) to improve the nutritional status and patient outcome after surgery to remove a cancerous bladder (radical cystectomy). Radical cystectomy with urinary diversion using a segment of intestine is the standard of care for invasive bladder cancer. This operation has a high complication rate and several studies have shown that this may be directly related to poor nutrition.

The investigators believe that patients who consume an enriched nutritional shake before and after surgery will improve their nutrition status and experience fewer complications, shorter length of stay and less readmissions compared to those who do not.

Patients who are scheduled to undergo elective radical cystectomy will be eligible for enrollment. Once enrolled, they will be randomly assigned to one of two groups. One group will be offered Ensure Plus® twice daily for 2 weeks before and 4 weeks after their surgery and the other will be offered a daily over-the-counter multivitamin for the same period of time. The investigators will follow both groups for up to 30 days after their surgery and compare clinical outcomes such as: complication rates, length of stay, readmission rates and mortality as well as measure serum markers of nutrition status and assess changes in body composition.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • all patients eligible for elective radical cystectomy for bladder cancer at the sponsoring institution

排除标准

  • inability to tolerate oral supplementation

结局指标

主要结局

Hospital-free days (HFDs)

时间窗: 30 days

The study is powered to detect a difference in the number of HFDs over a 30 day period between intervention and control groups

次要结局

  • Complications(30 days)
  • Length of stay(30 days)
  • Body composition(30 days)
  • Calories(30 days)
  • Tolerability / compliance(30 days)
  • Serum markers(30 days)
  • Readmission rate(30 days)
  • Mortality(30 days)

研究者

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

Chad Ritch

Clinical Instructor

Vanderbilt University

研究点 (2)

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