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临床试验/NCT01540942
NCT01540942已完成不适用

A Randomized, Controlled, Open-label Study to Investigate the Impact of Disease Activity and Nutrition Treat on Postoperative Recurrence and Complications After Bowel Resection for Crohn's Disease

Jinling Hospital, China1 个研究点 分布在 1 个国家目标入组 91 人开始时间: 2011年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
91
试验地点
1
主要终点
postoperative complications

研究概览

简要总结

The study was aimed to determine whether perioperative nutrition treat and(or)the perioperative disease activity were associated with postoperative recurrence and complications after bowel resection for Crohn's disease.

详细描述

The investigators want to assess the impact of possible risk factors on intestinal resection and postoperative recurrence in Crohn's disease (CD) and to evaluate the disease course.

In our clinical treatments, the investigators found that perioperative CDAI and nutrition treatment may have same impact on postoperative recurrence and complication in Crohn's disease. The investigators design this study to test it.

The study prepare to collect the clinical data of patients who need bowel resection for CD to analyzed. The investigators divide those patients into two groups (N,I group). They accept intestinal nutrition with the respective aim that get the inflammatory index (erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), Crohns Disease Activity Index (CDAI)) norm or nutritional index norm before they accept surgery. Postoperative recurrence and complications in patients will be recorded and compared.

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
Single (Participant)

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

入选标准

  • Patients had a CRP level of more than 8mg/L Patients had a preoperative weight loss >5% over the past 6 months and had a serum albumin of less than 35g/L at the enrollment

排除标准

  • 未提供

结局指标

主要结局

postoperative complications

时间窗: 4 weeks

次要结局

  • postoperative recurrence(52 weeks)

研究者

发起方
Jinling Hospital, China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhu Weiming

vice director of General surgery institute

Jinling Hospital, China

研究点 (1)

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