Inmediate Feeding Tolerance in Patients With Mild and Acute Biliary Pancreatitis vs Early Feeding
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 主要终点
- Pancreatitis reactivation after oral Feeding
研究概览
简要总结
Objective: Determine tolerance of immediate oral intake (8 hours posterior to the beginning of treatment) against traditional management (early feeding at 48hr) in patients with mild acute pancreatitis of biliary origin.
Double blind, randomized clinical trial
详细描述
The investigators included patients 15 - 85 years old, any sex. Diagnosis of mild acute pancreatitis according to the Ranson, APACHE II and BISAP.
Signed infromed consent to participate in the study. All participants had a hepatic and biliary ultrasound to determine the biliary etiology.
The investigators excluded patients with pancreatitis of nonbiliary etiology, pregnant, severe pancreatitis, cholangitis or choledocholithiasis demonstrated during the hospital stay or with other comorbidities.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
blinding of the evaluator to the study group blinding of patient to study hypothesis
入排标准
- 年龄范围
- 15 Years 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 15 years.
- •Patients with a diagnosis of mild acute pancreatitis biliary.
- •Patients who agree to enter the protocol.
排除标准
- •Patients managed at another institution.
- •Patients with a diagnosis of pancreatitis of non-biliary etiology.
- •Patients with heart disease or lung disease.
- •Patients with organic failure.
- •Patients with pregnancy.
- •Patients with cholangitis.
结局指标
主要结局
Pancreatitis reactivation after oral Feeding
时间窗: Measures at 48hours after the begining of the oral intake
Resurgence of characteristically epigastric tansfictive pain, irradiated to the left, upper quadrant region after beginning the oral intake, systemic inflammatory response syndrome ( C reactive protein) or Significant leucocyte elevation
次要结局
未报告次要终点
研究者
David Esmer
head of the surgery service of Central Hospital, SLP, Mex
Hospital Central "Dr. Ignacio Morones Prieto"