Clinical trial NCT01540942: Impact of Disease Activity and Nutrition Treat on Postoperative Recurrence and Complications After Bowel Resection for Crohn's Disease
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Crohn's Disease
Keywords: Crohn's disease
Nutrition
Bowel resection
Postoperative recurrence
complication
Active disease
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
First posted: 2012-02-29
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: postoperative complications
timeFrame: 4 weeks
Secondary outcomes:
measure: postoperative recurrence
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Weiming Zhu
state: Jiangsu
Study officials:
References:
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citation: Zhu W, Guo Z, Zuo L, Gong J, Li Y, Gu L, Cao L, Li N, Li J. CONSORT: Different End-Points of Preoperative Nutrition and Outcome of Bowel Resection of Crohn Disease: A Randomized Clinical Trial. Medicine (Baltimore). 2015 Jul;94(29):e1175. doi: 10.1097/MD.0000000000001175.