NCT04377230Unknown3 期
Impact of Biliopancreatic Limb Length of 60cm vs 100cm in Roux-en-Y Gastric Bypass on Bone Mineral Density 2 Years After Surgery
Hospital General Universitario Elche0 个研究点目标入组 200 人开始时间: 2020年5月7日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 200
- 主要终点
- Bone mineral density
研究概览
简要总结
Patients will be randomized into 2 groups:
- Group 60: Patients will undergo a Roux-en-Y gastric bypass with a Biliopancreatic limb length of 60cm
- Group 100: Patients will undergo a Roux-en-Y gastric bypass with a Biliopancreatic limb length of 100cm
Bone mineral density will be evaluated before surgery and 2 years after it.
详细描述
Patients will be randomized into 2 groups:
- Group 60: Patients will undergo a Roux-en-Y gastric bypass with a Biliopancreatic limb length of 60cm
- Group 100: Patients will undergo a Roux-en-Y gastric bypass with a Biliopancreatic limb length of 100cm Alimentary limb will be constant in both groups (150cm length)
Bone mineral density will be evaluated before surgery and 2 years after it, by means of X ray absorptiometry (DEXA). Changes in bone mineral density in lumbar column will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
盲法说明
The radiologist evaluating bone mineral density will be blinded to the biliopancreatic limb length
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body mass index >40 Kg/m2
- •Body mass index >35 Kg/m2 associated to obesity related comorbidities
排除标准
- •Bone pathologies
- •Active neoplasms
- •Disorders in calcium or vitamin D metabolism
结局指标
主要结局
Bone mineral density
时间窗: 2 years after surgery
Bone mineral density will be evealuated by absorptiometry at the level of lumbar column
次要结局
未报告次要终点
研究者
Jaime Ruiz-Tovar, MD, PhD
Department of Surgery
Hospital General Universitario Elche
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