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临床试验/NCT02142257
NCT02142257Unknown不适用

Gastric Bypass Procedure and AspireAssist Aspiration Therapy System for the Treatment of Morbid Obesity, Observational Study Over 5 Years

Blekinge County Council Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2014年5月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1
主要终点
Weight Loss

研究概览

简要总结

The purpose of this study is to compare Gastric Bypass and AspireAssist Aspiration Therapy over 5 years of treatment with regards to weight loss, quality of life, complications, adverse events, and health economics.

详细描述

Overweight and obesity is increasing rapidly in Sweden and is the greatest threat to future public health. Obesity, defined according to the World Health Organization (WHO) as a body mass index (BMI) greater than 30 kg/m2, is an intractable disease in healthcare today. Obesity results in reduced life expectancy and increased morbidity.

Weight reduction by lifestyle changes or with different pharmacological preparations have in many studies not made lasting long term results. Obesity surgery has so far been the only way to achieve permanent weight loss. During the 1980s, restrictive procedures were performed, e.g., vertical banded gastro-plasty (VBG) with good but unfortunately transient effect. Later developed, is the now prevalent gastric bypass procedure (GBP) which today uses the keyhole technique and causes combined restrictive and mal-absorptive changes in gastrointestinal anatomy.

GBP is currently the standard method in clinical practice for the surgical treatment of morbid obesity (i.e., BMI over 35). GBP is a procedure that is not reversible, which entail certain pre - and postoperative risks. GBP quickly brings a sharp reduction in weight and also regression of diabetes mellitus type 2. Unfortunately, the surgery cause lifelong mal-absorption and requirements of vitamin and mineral supplements.

Swedish Obese Subjects study (SOS) that emanated from Gothenburg was the first controlled intervention study of overweight individuals. Approximately 4000 patients were included, half of which were surgical, the other half were treated optimally, but without surgery. The patients have been followed for 10-20 years. Total mortality was 24% lower in the surgical group.

A new alternative approach to obesity surgery, AspireAssist™ Aspiration Therapy System (CE Marked), comes from the United States and in this method the individual empties out digesta from the stomach. Percutaneous endoscopic gastrostomy (PEG) has been used internationally since the early 1980s for nutrition therapy for stroke or cancer. In a gastroscopy a tube is placed between the stomach and abdominal wall and nutrition administered via tube directly into the stomach.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • •age 20-60 years
  • •body mass index over 35
  • •the absence of an eating disorder
  • •severe co-morbidity
  • •failure to achieve weight loss with lifestyle changes or other conservative approaches

排除标准

  • •Recent myocardial infarction (3 months)
  • •Ongoing cancer
  • •Chronic liver and / or kidney disease
  • •Mental illness, including substance abuse and eating disorders that can exclude the patient from aspiration therapy.
  • •Discovery of severe disease of the stomach on endoscopy

结局指标

主要结局

Weight Loss

时间窗: year 1 - quarterly, years 2-5 once per year

% Excess Weight loss based on ideal body weight with BMI of 25

次要结局

  • Quality of Life(annually, up to 5 years)

研究者

发起方
Blekinge County Council Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Max O Nystrom

Dr Max O Nystrom

Blekinge County Council Hospital

研究点 (1)

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