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

Phase 4

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

• Registration Number: NCT03901937
• Lead Sponsor: Sir Run Run Shaw Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-01
• Study First Submitted: 2019-03-12
• Status Verified: 2019-04
• Study First Submitted QC: 2019-04-02
• Last Update Submitted: 2019-04-02
• Study First Posted: 2019-04-03
• Last Update Posted: 2019-04-03
• Primary Completion: 2020-09-01
• Study Completion: 2021-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 158

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	ω-3 polyunsaturated fatty acid	parenteral nutrition without ω-3 polyunsaturated fatty acid
Placebo	Intestinal surgery for Crohn's Disease	parenteral nutrition without ω-3 polyunsaturated fatty acid
ω-3 fatty acid	Intestinal surgery for Crohn's Disease	parenteral nutrition with ω-3 polyunsaturated fatty acid

Primary Outcome Measures

Name	Time	Method
Rate of Postoperative complications	postoperative 1-30 days	postoperative complications after surgery for Crohn's Disease according to clavien-dindo system

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Sir Run Run Shaw hospital; 🇨🇳 Hangzhou, Zhejiang, China