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临床试验/NCT01652105
NCT01652105Unknown不适用

Comparison of Preoperative Diets Before Bariatric Surgery: a Randomized Controlled Trial

Lievensberg Ziekenhuis2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2012年9月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
2
主要终点
Preoperative weight loss before bariatric surgery

研究概览

简要总结

Randomized clinical trial of two preoperative diets before bariatric surgery (gastric bypass)comparing standard diet and Prodimed (VLCD) in 100 morbidly obese patients selected for a gastric bypass procedure

详细描述

Morbid obesity, defined as a body mass index (BMI) of > 40 kg/m² or > 35 kg/m² with obesity-related comorbidities, is a rapidly growing problem in the western society. In the United States, about 6 million people currently have a BMI of > 40 kg/m² and another 10 million people have a BMI of > 35 kg/m² with comorbidities. Worldwide, the incidence of morbid obesity has doubled and about 300 million people are now obese. In the Netherlands the prevalence is less disturbing but the incidence of morbid obesity is rising progressively to 1.5% of the total population. At this moment surgical therapy is the only treatment option for these patients that results in sufficient long-term weight loss. Non-surgical approaches, like low energy diets and behavior modification, are not successful in the long-term with respect to maintaining weight loss and decreasing obesity-related comorbidities.

In order to increase weight loss and minimize complications a preoperative diet before bariatric has been advocated. However, the usual VLCD's are poorly tolerated by patients. In this study we aim to compare two preoperative diets in order to find the most suitable for this patient population.

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
Single (Care Provider)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • morbid obesity according to IFSO criteria

排除标准

  • previous bariatric or gastric surgery
  • severe psychiatric disorders

结局指标

主要结局

Preoperative weight loss before bariatric surgery

时间窗: 2 weeks

Weight loss in kg before operation

次要结局

  • - operation time - blood loss - difficulty of procedure - short term complications - acceptance of diets according to patients(2 weeks)

研究者

发起方
Lievensberg Ziekenhuis
申办方类型
Other
责任方
Principal Investigator
主要研究者

R. Schouten

MD, PhD

Lievensberg Ziekenhuis

研究点 (2)

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