NCT03901937Unknown4 期
Department of General Surgery, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, 310016, China
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 158
- 试验地点
- 1
- 主要终点
- Rate of Postoperative complications
研究概览
简要总结
This study is intended to investigate the safety and efficacy of ω-3 polyunsaturated fatty acid-based parenteral nutrition (PN) for patients with Crohn's disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis as Crohn's disease according to definition;
- •Bowel resection;
- •With parenteral nutrition at least 5 days
- •18 years old<age<75 years old;
- •Sign the informed consent.
排除标准
- •Emergency surgery;
- •With severe comorbidity and/or organ (kidney,liver,or heart) dysfunction;
- •Incomplete laboratory data;
- •With parenteral nutrition before surgery;
- •Allergy of ω-3 polyunsaturated fatty acid.
研究组 & 干预措施
Placebo
Placebo Comparator
parenteral nutrition without ω-3 polyunsaturated fatty acid
干预措施: ω-3 polyunsaturated fatty acid (Drug)
Placebo
Placebo Comparator
parenteral nutrition without ω-3 polyunsaturated fatty acid
干预措施: Intestinal surgery for Crohn's Disease (Procedure)
ω-3 fatty acid
Experimental
parenteral nutrition with ω-3 polyunsaturated fatty acid
干预措施: Intestinal surgery for Crohn's Disease (Procedure)
结局指标
主要结局
Rate of Postoperative complications
时间窗: postoperative 1-30 days
postoperative complications after surgery for Crohn's Disease according to clavien-dindo system
次要结局
- Blood Concentration of albumin(postoperative 1, 3, and 6 day)
- Blood Concentration of IL-6(postoperative 1, 3, and 6 day)
- Length of postoperative hospital stay(from surgery to discharge)
- Blood Concentration of TNF-α(postoperative 1, 3, and 6 day)
- Blood White blood cell level(postoperative 1, 3, and 6 day)
- Blood Concentration of IL-1β(postoperative 1, 3, and 6 day)
- Blood Concentration of C-reactive protein(postoperative 1, 3, and 6 day)
研究者
Wei Zhou
Clinical Professor
Sir Run Run Shaw Hospital
研究点 (1)
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