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临床试验/NCT04486079
NCT04486079Unknown4 期

Preoperative Carbohydrate Loading in Bariatric Surgery - Randomized Clinical Trail

Medical University of Gdansk2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2020年7月20日最近更新:
适应症

试验速览

阶段
4 期
入组人数
400
试验地点
2
主要终点
QoR40 score

研究概览

简要总结

The aim of this study is to perform a randomized non-blinded clinical trial to assess influence of preoperative carbohydrates loading in patients undergoing bariatric surgery measured by changes in the course of the postoperative period, changes in body composition and changes in insulin resistance

研究设计

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

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

  • Obtaining written and informed patient consent.
  • No medical contraindications to perform a bariatric operation
  • No contraindications for the use of a rich carbohydrate drink

排除标准

  • No consent to participate in the study
  • Age under 18 years
  • The intolerance of the carbohydrate drink used in the test
  • The contraindications to perform bioimpedance measurements of body composition

结局指标

主要结局

QoR40 score

时间窗: 1st postoperatie day

Quality of recovery after surgery will be assessed by the QoR40 survey Full scale title: Quality of Recovery 40-item questionnaires range from 40 (extremely poor. quality of recovery) to 200 (excellent quality of recovery)

次要结局

  • Length of hospital stay(From the time of hospital admission following surgery, until the time of hospital discharge; assessed from day of hospital admision up to 30 days)
  • HOMA-IR(first assay one month before the operation, the second assay on the first postoperative day)
  • Body composition(first assay one month before the operation, the second assay on the first postoperative day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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