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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Zhu Weiming, Jinling Hospital, China
ClinicalTrials.gov Identifier:
NCT01540942
First received: February 23, 2012
Last updated: March 20, 2014
Last verified: March 2014

February 23, 2012
March 20, 2014
November 2011
December 2013   (final data collection date for primary outcome measure)
postoperative complications [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
postoperative recurrence [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01540942 on ClinicalTrials.gov Archive Site
postoperative recurrence [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
postoperative complications [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Impact of Disease Activity and Nutrition Treat on Postoperative Recurrence and Complications After Bowel Resection for Crohn's Disease
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

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Crohn's Disease
  • 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)]
  • Other: surgery
    bowel resection
  • Active Comparator: Nutrition treat
    perioperative nutrition support until the patients get the normal nutrition or disease remission
    Intervention: Dietary Supplement: nutrition treat
  • Active Comparator: bowel resection
    bowel resection until the patients get the normal nutrition or disease remission after bowel resection
    Intervention: Other: surgery

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
91
December 2013
December 2013   (final data collection date for primary outcome measure)

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

Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01540942
CDS-1
Not Provided
Zhu Weiming, Jinling Hospital, China
Jinling Hospital, China
Not Provided
Not Provided
Jinling Hospital, China
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP