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

This study is currently recruiting participants.
Verified March 2013 by Jinling Hospital, China
Sponsor:
Information provided by (Responsible Party):
Zhu Weiming, Jinling Hospital, China
ClinicalTrials.gov Identifier:
NCT01540942
First received: February 23, 2012
Last updated: March 25, 2013
Last verified: March 2013
History of Changes
  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: Open Label
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:

MedlinePlus related topics: Crohn's Disease
U.S. FDA Resources

Further study details as provided by Jinling Hospital, China:

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

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

Estimated Enrollment: 100
Study Start Date: November 2011
Estimated Study Completion Date: December 2013
Estimated 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:

  • Subjects should have a definitive diagnosis of Crohn's disease, based on WHO criteria
  • Subjects having curative resection/ileocolonic anastomosis，pathologically diagnosed as Crohn's disease
  • Subjects should need a surgical operation.
  • Males and females ≥ 18 years old, including women who are not pregnant or lactating at the time of enrollment.
  • Are capable of providing written informed consent and obtained at the time of enrollment
  • Willing to adhere to the study visit schedule and other protocol requirements.

Exclusion Criteria:

  • Bacterial,viral or other microbial infection(including HIV)
  • With short bowel syndrome (defined as requiring oral or parenteral supplemental or total nutrition to maintain stable body weight, or more than 100 cm of small bowel resected)
  • History of malignancy
  • Women who are pregnant or lactating at the time of enrollment, or who intend to be during the study period.
  • Participation in other clinical trial within the past 6 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01540942

Contacts
Contact: Zhu Wei ming, PhD,MD +86-25-80860137 juwiming@yahoo.com.cn

Locations
China, Jiangsu
Weiming Zhu Recruiting
Nanjing, Jiangsu, China, 210002
Contact: zhu wei ming, MD,PhD     +86-25-80860137     juwiming@yahoo.com.cn    
Principal Investigator: zhu wei ming, MD,Phd            
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 25, 2013
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 May 16, 2013