Bariatric Surgery on the West Coast of Norway (Vestlandet): Prospective Study of Overweight People Undergoing Bariatric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 543
- 试验地点
- 2
- 主要终点
- weight loss
研究概览
简要总结
Bariatric surgery of morbid obesity was first located at Førde Central Hospital, but it is now an established treatment at several other hospitals in the health region (Voss Hospital (Helse Bergen), Haugesund Hospital (Helse Fonna) Stavanger University Hospital ((SUS) Helse Stavanger). Surgical methods vary between hospitals: Voss: sleeve gastrectomy, Haugesund: gastric bypass (Roux-en Y),SUS: gastric bypass (Roux-en Y); Førde: biliopancreatic diversion with duodenal switch (BPD / DS) and sleeve gastrectomy . The investigators have then in Helse-Vest a unique opportunity to examine the various clinical and metabolic effects from different surgical methods.
This project is part of the regional strategic research initiative in the Helse Vest
详细描述
Primary endpoints for the study are weight loss and self-reported quality of life (QoL) evaluated by Short Form (SF)-36 and Impact of Weight Wed Quality of Life-Lite (IWQOL-Lite)) Our hypothesis is that patients operated with RYGBP (Roux A-Y Gastric Bypass) and BPD / DS (biliopancreatic diversion with duodenal switch) have the same weight and same QoL after 5 years of follow-up as patients treated with gastric sleeve (laparoscopic gastric sleeve (LSG)) We will also compare the groups with respect to a number of secondary endpoints
400 patients (approximately 100 patients / institution) will be included in the main study. Some of the programs that run on secondary endpoints will be conducted separately under study at each hospital. These studies will be reported in separate articles.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both sexes 18-60 years old
- •Patients with morbid obesity that is applied to the bariatric surgery.
- •Signed informed consent
排除标准
- •Patients who become pregnant in the follow-up period will not continue in the study but the data will be treated as lost too follow up.
结局指标
主要结局
weight loss
时间窗: From 1 year and up to 5 years
次要结局
- remission of diabetes mellitus type 2(from 1 year up to 5 years)
研究者
Bjørn Gunnar Nedrebø, MD, PhD
MD, PhD
Helse Fonna