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NCT01540942 Clinical Trial

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

Crohn's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01540942
Other study ID # CDS-1
Secondary ID
Status Completed
Phase N/A
First received February 23, 2012
Last updated March 20, 2014
Start date November 2011
Est. completion date December 2013

Study information
Verified date March 2014
Source Jinling Hospital, China
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 91
Est. completion date December 2013
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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

Study Design

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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
China Weiming Zhu Nanjing Jiangsu

Sponsors (1)
Lead Sponsor Collaborator
Jinling Hospital, China

Country where clinical trial is conducted

China, 

References & Publications (8)

Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibañes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2. — View Citation

Cosnes J, Beaugerie L, Carbonnel F, Gendre JP. Smoking cessation and the course of Crohn's disease: an intervention study. Gastroenterology. 2001 Apr;120(5):1093-9. — View Citation

Johnson GJ, Cosnes J, Mansfield JC. Review article: smoking cessation as primary therapy to modify the course of Crohn's disease. Aliment Pharmacol Ther. 2005 Apr 15;21(8):921-31. Review. — View Citation

McLeod RS, Wolff BG, Ross S, Parkes R, McKenzie M; Investigators of the CAST Trial. Recurrence of Crohn's disease after ileocolic resection is not affected by anastomotic type: results of a multicenter, randomized, controlled trial. Dis Colon Rectum. 2009 May;52(5):919-27. doi: 10.1007/DCR.0b013e3181a4fa58. — View Citation

Olaison G, Smedh K, Sjödahl R. Natural course of Crohn's disease after ileocolic resection: endoscopically visualised ileal ulcers preceding symptoms. Gut. 1992 Mar;33(3):331-5. — View Citation

Reese GE, Nanidis T, Borysiewicz C, Yamamoto T, Orchard T, Tekkis PP. The effect of smoking after surgery for Crohn's disease: a meta-analysis of observational studies. Int J Colorectal Dis. 2008 Dec;23(12):1213-21. doi: 10.1007/s00384-008-0542-9. Epub 2008 Sep 2. — View Citation

Rutgeerts P, Geboes K, Vantrappen G, Kerremans R, Coenegrachts JL, Coremans G. Natural history of recurrent Crohn's disease at the ileocolonic anastomosis after curative surgery. Gut. 1984 Jun;25(6):665-72. — View Citation

Yamamoto T. Factors affecting recurrence after surgery for Crohn's disease. World J Gastroenterol. 2005 Jul 14;11(26):3971-9. Review. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary postoperative complications 4 weeks No
Secondary postoperative recurrence 52 weeks No
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