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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

158 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2021-03-01

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.

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Detailed Description

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Conditions

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Crohn Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

parenteral nutrition without ω-3 polyunsaturated fatty acid

Group Type PLACEBO_COMPARATOR

ω-3 polyunsaturated fatty acid

Intervention Type DRUG

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).

Intestinal surgery for Crohn's Disease

Intervention Type PROCEDURE

Patients receive bowel resection due to complications of Crohn's Disease

ω-3 fatty acid

parenteral nutrition with ω-3 polyunsaturated fatty acid

Group Type EXPERIMENTAL

Intestinal surgery for Crohn's Disease

Intervention Type PROCEDURE

Patients receive bowel resection due to complications of Crohn's Disease

Interventions

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ω-3 polyunsaturated fatty acid

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).

Intervention Type DRUG

Intestinal surgery for Crohn's Disease

Patients receive bowel resection due to complications of Crohn's Disease

Intervention Type PROCEDURE

Other Intervention Names

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Omegaven®10%

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No