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

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

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.

Study Overview

• Status: Unknown
• Conditions: Crohn Disease
• Intervention / Treatment: Drug: ω-3 polyunsaturated fatty acid; Procedure: Intestinal surgery for Crohn's Disease

• Study Type: Interventional
• Enrollment (Anticipated): 158
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Wei Zhou, MD PHD; Phone Number: 13588706479; Email: zhouw@srrsh.com

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310016
      • Recruiting
      • Sir Run Run Shaw Hospital
      • Contact: Xiaolong Ge, PhD; Phone Number: 13867106984; Email: gxlnjumed09@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo; parenteral nutrition without ω-3 polyunsaturated fatty acid	Drug: 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).; Other Names: Omegaven®10%; Procedure: Intestinal surgery for Crohn's Disease; Patients receive bowel resection due to complications of Crohn's Disease
EXPERIMENTAL: ω-3 fatty acid; parenteral nutrition with ω-3 polyunsaturated fatty acid	Procedure: Intestinal surgery for Crohn's Disease; Patients receive bowel resection due to complications of Crohn's Disease

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sir Run Run Shaw Hospital
• Investigators: Study Chair: Xiujun Cai, Sir Run Run Shaw Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2019
• Primary Completion (ANTICIPATED): September 1, 2020
• Study Completion (ANTICIPATED): March 1, 2021

Study Registration Dates

• First Submitted: March 12, 2019
• First Submitted That Met QC Criteria: April 2, 2019
• First Posted (ACTUAL): April 3, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 3, 2019
• Last Update Submitted That Met QC Criteria: April 2, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: postoperative complications
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease; Postoperative Complications
• Other Study ID Numbers: SRRSH20180925-8

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data collection from 2019-3 to 2020-9

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No