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

Primary Purpose

Crohn's Disease

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
nutrition treat
surgery
Sponsored by
Jinling Hospital, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease focused on measuring Crohn's disease, Nutrition, Bowel resection, Postoperative recurrence, complication, Active disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Weiming Zhu

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Nutrition treat

bowel resection

Arm Description

perioperative nutrition support until the patients get the normal nutrition or disease remission

bowel resection until the patients get the normal nutrition or disease remission after bowel resection

Outcomes

Primary Outcome Measures

postoperative complications

Secondary Outcome Measures

postoperative recurrence

Full Information

First Posted
February 23, 2012
Last Updated
March 20, 2014
Sponsor
Jinling Hospital, China
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1. Study Identification

Unique Protocol Identification Number
NCT01540942
Brief Title
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

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jinling Hospital, China

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
Keywords
Crohn's disease, Nutrition, Bowel resection, Postoperative recurrence, complication, Active disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
91 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nutrition treat
Arm Type
Active Comparator
Arm Description
perioperative nutrition support until the patients get the normal nutrition or disease remission
Arm Title
bowel resection
Arm Type
Active Comparator
Arm Description
bowel resection until the patients get the normal nutrition or disease remission after bowel resection
Intervention Type
Dietary Supplement
Intervention Name(s)
nutrition treat
Intervention Description
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)]
Intervention Type
Other
Intervention Name(s)
surgery
Intervention Description
bowel resection
Primary Outcome Measure Information:
Title
postoperative complications
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
postoperative recurrence
Time Frame
52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Weiming Zhu
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
1568651
Citation
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Results Reference
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PubMed Identifier
18762954
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.
Results Reference
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PubMed Identifier
19638912
Citation
Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes 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.
Results Reference
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PubMed Identifier
6735250
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. doi: 10.1136/gut.25.6.665.
Results Reference
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PubMed Identifier
19502857
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.
Results Reference
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PubMed Identifier
15996018
Citation
Yamamoto T. Factors affecting recurrence after surgery for Crohn's disease. World J Gastroenterol. 2005 Jul 14;11(26):3971-9. doi: 10.3748/wjg.v11.i26.3971.
Results Reference
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PubMed Identifier
11266373
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. doi: 10.1053/gast.2001.23231.
Results Reference
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PubMed Identifier
15813828
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. doi: 10.1111/j.1365-2036.2005.02424.x.
Results Reference
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PubMed Identifier
26200619
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.
Results Reference
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Impact of Disease Activity and Nutrition Treat on Postoperative Recurrence and Complications After Bowel Resection for Crohn's Disease

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