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Clinical Trials/NCT01540942
NCT01540942
Completed
Not Applicable

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

Jinling Hospital, China1 site in 1 country91 target enrollmentNovember 2011
ConditionsCrohn's Disease

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Crohn's Disease
Sponsor
Jinling Hospital, China
Enrollment
91
Locations
1
Primary Endpoint
postoperative complications
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
November 2011
End Date
December 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Jinling Hospital, China
Responsible Party
Principal Investigator
Principal Investigator

Zhu Weiming

vice director of General surgery institute

Jinling Hospital, China

Eligibility 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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

postoperative complications

Time Frame: 4 weeks

Secondary Outcomes

  • postoperative recurrence(52 weeks)

Study Sites (1)

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