The Effects of Parenteral ω-3 Polyunsaturated Fatty Acid on Postoperative Complications of Patients With Crohn's Disease

Study Overview
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Brief Summary
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This study is intended to investigate the safety and efficacy of ω-3 polyunsaturated fatty acid-based parenteral nutrition (PN) for patients with Crohn's disease.

Official Title
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Department of General Surgery, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, 310016, China

Conditions
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Crohn Disease

Intervention / Treatment
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* Drug: ω-3 polyunsaturated fatty acid
* Procedure: Intestinal surgery for Crohn's Disease


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis as Crohn's disease according to definition; Bowel resection; With parenteral nutrition at least 5 days 18 years old<age<75 years old; Sign the informed consent. Exclusion Criteria: Emergency surgery; With severe comorbidity and/or organ (kidney,liver,or heart) dysfunction; Incomplete laboratory data; With parenteral nutrition before surgery; Pregnant; Allergy of ω-3 polyunsaturated fatty acid.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>parenteral nutrition without ω-3 polyunsaturated fatty acid | Drug: ω-3 polyunsaturated fatty acid<br>* CD patients are divided into two groups, which include with and without ω-3 polyunsaturated fatty acid-based PN (0.1-0.2g/kg/d).<br>* Other names: Omegaven®10%;Procedure: Intestinal surgery for Crohn's Disease<br>* Patients receive bowel resection due to complications of Crohn's Disease<br>|
| Experimental: ω-3 fatty acid<br>parenteral nutrition with ω-3 polyunsaturated fatty acid | Procedure: Intestinal surgery for Crohn's Disease<br>* Patients receive bowel resection due to complications of Crohn's Disease<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Postoperative complications | postoperative complications after surgery for Crohn's Disease according to clavien-dindo system | postoperative 1-30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of postoperative hospital stay | postoperative hospital stay after surgery for Crohn's Disease | from surgery to discharge | 
| Blood Concentration of IL-6 | Blood Concentration of IL-6 after surgery | postoperative 1, 3, and 6 day | 
| Blood Concentration of TNF-α | Blood Concentration of TNF-α after surgery | postoperative 1, 3, and 6 day | 
| Blood Concentration of IL-1β | Blood Concentration of IL-1β after surgery | postoperative 1, 3, and 6 day | 
| Blood Concentration of albumin | Blood Concentration of albumin after surgery | postoperative 1, 3, and 6 day | 
| Blood Concentration of C-reactive protein | Blood Concentration of C-reactive protein after surgery | postoperative 1, 3, and 6 day | 
| Blood White blood cell level | Blood White blood cell level after surgery | postoperative 1, 3, and 6 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postoperative complications