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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01540942
Enrollment
91
Registered
2012-02-29
Start date
2011-11-30
Completion date
2013-12-31
Last updated
2014-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's Disease

Keywords

Crohn's disease, Nutrition, Bowel resection, Postoperative recurrence, complication, Active disease

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.

Interventions

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

OTHERsurgery

bowel resection

Sponsors

Jinling Hospital, China
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
postoperative complications4 weeks

Secondary

MeasureTime frame
postoperative recurrence52 weeks

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026