The Effects of Parenteral ω-3 Polyunsaturated Fatty Acid on Postoperative Complications of Patients With Crohn's Disease (ω3CD)

Zhejiang University

Status and phase: Unknown; Phase 4

Conditions: Crohn Disease

Treatments: Procedure: Intestinal surgery for Crohn's Disease; Drug: ω-3 polyunsaturated fatty acid

Study type: Interventional

Funder types: Other

Identifiers

NCT03901937

SRRSH20180925-8

Details and patient eligibility

About

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.

Enrollment: 158 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosis as Crohn's disease according to definition;
2. Bowel resection;
3. With parenteral nutrition at least 5 days
4. 18 years old<age<75 years old;
5. Sign the informed consent.

Exclusion criteria

1. Emergency surgery;
2. With severe comorbidity and/or organ (kidney,liver,or heart) dysfunction;
3. Incomplete laboratory data;
4. With parenteral nutrition before surgery;
5. Pregnant;
6. Allergy of ω-3 polyunsaturated fatty acid.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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158 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

parenteral nutrition without ω-3 polyunsaturated fatty acid

Treatment:

Drug: ω-3 polyunsaturated fatty acid

Procedure: Intestinal surgery for Crohn's Disease

ω-3 fatty acid

Experimental group

Description:

parenteral nutrition with ω-3 polyunsaturated fatty acid

Treatment:

Procedure: Intestinal surgery for Crohn's Disease