Impact of Disease Activity and Nutrition Treat on Postoperative Recurrence and Complications After Bowel Resection for Crohn's Disease
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|ClinicalTrials.gov Identifier: NCT01540942|
Recruitment Status : Completed
First Posted : February 29, 2012
Last Update Posted : March 21, 2014
|Condition or disease||Intervention/treatment||Phase|
|Crohn's Disease||Dietary Supplement: nutrition treat Other: surgery||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||91 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||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|
|Study Start Date :||November 2011|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2013|
Active Comparator: Nutrition treat
perioperative nutrition support until the patients get the normal nutrition or disease remission
Dietary Supplement: nutrition treat
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）]
Active Comparator: bowel resection
bowel resection until the patients get the normal nutrition or disease remission after bowel resection
- postoperative complications [ Time Frame: 4 weeks ]
- postoperative recurrence [ Time Frame: 52 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01540942
|Nanjing, Jiangsu, China, 210002|