search
Back to results

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

Primary Purpose

Crohn Disease

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
ω-3 polyunsaturated fatty acid
Intestinal surgery for Crohn's Disease
Sponsored by
Sir Run Run Shaw Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Crohn Disease focused on measuring postoperative complications

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Sir Run Run Shaw hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

ω-3 fatty acid

Arm Description

parenteral nutrition without ω-3 polyunsaturated fatty acid

parenteral nutrition with ω-3 polyunsaturated fatty acid

Outcomes

Primary Outcome Measures

Rate of Postoperative complications
postoperative complications after surgery for Crohn's Disease according to clavien-dindo system

Secondary Outcome Measures

Length of postoperative hospital stay
postoperative hospital stay after surgery for Crohn's Disease
Blood Concentration of IL-6
Blood Concentration of IL-6 after surgery
Blood Concentration of TNF-α
Blood Concentration of TNF-α after surgery
Blood Concentration of IL-1β
Blood Concentration of IL-1β after surgery
Blood Concentration of albumin
Blood Concentration of albumin after surgery
Blood Concentration of C-reactive protein
Blood Concentration of C-reactive protein after surgery
Blood White blood cell level
Blood White blood cell level after surgery

Full Information

First Posted
March 12, 2019
Last Updated
April 2, 2019
Sponsor
Sir Run Run Shaw Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03901937
Brief Title
The Effects of Parenteral ω-3 Polyunsaturated Fatty Acid on Postoperative Complications of Patients With Crohn's Disease
Acronym
ω3CD
Official Title
Department of General Surgery, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, 310016, China
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
September 1, 2020 (Anticipated)
Study Completion Date
March 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sir Run Run Shaw Hospital

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease
Keywords
postoperative complications

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
158 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
parenteral nutrition without ω-3 polyunsaturated fatty acid
Arm Title
ω-3 fatty acid
Arm Type
Experimental
Arm Description
parenteral nutrition with ω-3 polyunsaturated fatty acid
Intervention Type
Drug
Intervention Name(s)
ω-3 polyunsaturated fatty acid
Other Intervention Name(s)
Omegaven®10%
Intervention Description
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
Procedure
Intervention Name(s)
Intestinal surgery for Crohn's Disease
Intervention Description
Patients receive bowel resection due to complications of Crohn's Disease
Primary Outcome Measure Information:
Title
Rate of Postoperative complications
Description
postoperative complications after surgery for Crohn's Disease according to clavien-dindo system
Time Frame
postoperative 1-30 days
Secondary Outcome Measure Information:
Title
Length of postoperative hospital stay
Description
postoperative hospital stay after surgery for Crohn's Disease
Time Frame
from surgery to discharge
Title
Blood Concentration of IL-6
Description
Blood Concentration of IL-6 after surgery
Time Frame
postoperative 1, 3, and 6 day
Title
Blood Concentration of TNF-α
Description
Blood Concentration of TNF-α after surgery
Time Frame
postoperative 1, 3, and 6 day
Title
Blood Concentration of IL-1β
Description
Blood Concentration of IL-1β after surgery
Time Frame
postoperative 1, 3, and 6 day
Title
Blood Concentration of albumin
Description
Blood Concentration of albumin after surgery
Time Frame
postoperative 1, 3, and 6 day
Title
Blood Concentration of C-reactive protein
Description
Blood Concentration of C-reactive protein after surgery
Time Frame
postoperative 1, 3, and 6 day
Title
Blood White blood cell level
Description
Blood White blood cell level after surgery
Time Frame
postoperative 1, 3, and 6 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wei Zhou, MD PHD
Phone
13588706479
Email
zhouw@srrsh.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiujun Cai
Organizational Affiliation
Sir Run Run Shaw Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Sir Run Run Shaw hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310016
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaolong Ge, PhD
Phone
13867106984
Email
gxlnjumed09@126.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data collection from 2019-3 to 2020-9

Learn more about this trial

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

We'll reach out to this number within 24 hrs