Impact of Disease Activity and Nutrition Treat on Postoperative Recurrence and Complications After Bowel Resection for Crohn's Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Crohn's Disease

Intervention / Treatment
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* Dietary Supplement: nutrition treat
* Other: surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nutrition treat<br>perioperative nutrition support until the patients get the normal nutrition or disease remission | Dietary Supplement: nutrition treat<br>* intestinal nutrition treat :female：REE（Kcal/d）=655+9.6W+1.7H-4.7A; male：REE（Kcal/d）=66+13.7W+5.0H-6.8A;[W=weight（Kg）；H=height（cm）；A=age（year）]<br>|
| Active Comparator: bowel resection<br>bowel resection until the patients get the normal nutrition or disease remission after bowel resection | Other: surgery<br>* bowel resection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative complications |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative recurrence |  | 52 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Crohn's disease, Nutrition, Bowel resection, Postoperative recurrence, complication, Active disease