NCT01540942

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 29, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

March 21, 2014

Status Verified

March 1, 2014

Enrollment Period

2.1 years

First QC Date

February 23, 2012

Last Update Submit

March 20, 2014

Conditions

Crohn's Disease

Keywords

Crohn's diseaseNutritionBowel resectionPostoperative recurrencecomplicationActive disease

Outcome Measures

Primary Outcomes (1)

  • postoperative complications

    4 weeks

Secondary Outcomes (1)

  • postoperative recurrence

    52 weeks

Study Arms (2)

Nutrition treat

ACTIVE COMPARATOR

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

Dietary Supplement: nutrition treat

bowel resection

ACTIVE COMPARATOR

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

Other: surgery

Interventions

nutrition treatDIETARY_SUPPLEMENT

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;\[W=weight（Kg）；H=height（cm）；A=age（year）\]

Nutrition treat
surgeryOTHER

bowel resection

bowel resection

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weiming Zhu

Nanjing, Jiangsu, 210002, China

Location

Related Publications (9)

  • Olaison G, Smedh K, Sjodahl R. Natural course of Crohn's disease after ileocolic resection: endoscopically visualised ileal ulcers preceding symptoms. Gut. 1992 Mar;33(3):331-5. doi: 10.1136/gut.33.3.331.

    PMID: 1568651BACKGROUND

  • 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.

    PMID: 18762954BACKGROUND

  • 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.

    PMID: 19638912BACKGROUND

  • 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.

    PMID: 6735250BACKGROUND

  • 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.

    PMID: 19502857BACKGROUND

  • 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.

    PMID: 15996018BACKGROUND

  • 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.

    PMID: 11266373BACKGROUND

  • 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.

    PMID: 15813828BACKGROUND

  • 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.

    PMID: 26200619DERIVED

MeSH Terms

Conditions

Crohn Disease

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
vice director of General surgery institute

Study Record Dates

First Submitted

February 23, 2012

First Posted

February 29, 2012

Study Start

November 1, 2011

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

March 21, 2014

Record last verified: 2014-03

Locations

CN(1)