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
  Purpose

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.


Condition Intervention
Crohn's Disease
Dietary Supplement: nutrition treat
Other: surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Jinling Hospital, China:

Primary Outcome Measures:
  • postoperative complications [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • postoperative recurrence [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Enrollment: 91
Study Start Date: November 2011
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other: surgery
bowel resection

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01540942

Locations
China, Jiangsu
Weiming Zhu
Nanjing, Jiangsu, China, 210002
Sponsors and Collaborators
Jinling Hospital, China
  More Information

Publications:

Responsible Party: Zhu Weiming, vice director of General surgery institute, Jinling Hospital, China
ClinicalTrials.gov Identifier: NCT01540942     History of Changes
Other Study ID Numbers: CDS-1
Study First Received: February 23, 2012
Last Updated: March 20, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by Jinling Hospital, China:
Crohn's disease
Nutrition
Bowel resection
Postoperative recurrence
complication
Active disease

Additional relevant MeSH terms:
Crohn Disease
Recurrence
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on August 21, 2014