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临床试验/NCT02768506
NCT02768506已完成不适用

Non-randomized Prospective Comparison Between SADI-S and Gastric Bypass for the Treatment of Morbid Obesity and Its Associated Co-morbidities

Hospital San Carlos, Madrid1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2009年9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
50
试验地点
1
主要终点
Weight loss

研究概览

简要总结

Patients with BMI over 40 or with BMI over 35 and comorbidities are offered SADI-S with a variable limb length between 250 cm and 300 cm or gastric bypass.

Results on weight loss, comorbidities resolution, complications, re-operations, need of supplements are registered.

详细描述

Morbid obese patients and patients with an initial BMI over 35 with associated comorbidities - as diabetes mellitus - are evaluated for bariatric surgery. Candidates are offered a standard gastric bypass or a single anastomosis duodeno-ileal bypass with sleeve gastrectomy. Patients with higher BMI and those with worse metabolic condition are encouraged to accept the malabsorptive option.

Gastric bypass is performed with a 150 cm alimentary limb and a calibrated pouch and anastomosis over a 14 mm bougie. SADI-S is performed with a sleeve gastrectomy over a 54 French (18 mm) gastric bougie and a 250 cm common limb.

Patients are managed equally during admission: 6 hours to initiate oral intake, 2 days to remove abdominal drain and 3 days to discharge unless contraindicated. Follow up is performed through visits every 3 months the first 2 postoperative years and every 6 months from the 3rd to the 5th year.

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
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Morbid obesity

排除标准

  • Drug addiction
  • Alcoholic
  • Neoplasms
  • Immunosuppression
  • Mental diseases

结局指标

主要结局

Weight loss

时间窗: 5 years

Excess weight loss percentage and total weight loss percentage in the first 5 years

次要结局

  • Diabetes remission(5 years)

研究者

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

Andres Sanchez-Pernaute

PhD, MD

Hospital San Carlos, Madrid

研究点 (1)

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