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Trial record 1 of 1 for:    NCT03901937 | Crohn Disease
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The Effects of Parenteral ω-3 Polyunsaturated Fatty Acid on Postoperative Complications of Patients With Crohn's Disease (ω3CD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03901937
Recruitment Status : Unknown
Verified April 2019 by Wei Zhou, Sir Run Run Shaw Hospital.
Recruitment status was:  Recruiting
First Posted : April 3, 2019
Last Update Posted : April 3, 2019
Sponsor:
Information provided by (Responsible Party):
Wei Zhou, Sir Run Run Shaw Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Crohn Disease Drug: ω-3 polyunsaturated fatty acid Procedure: Intestinal surgery for Crohn's Disease Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 158 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Department of General Surgery, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, 310016, China
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : March 1, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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


Outcome Measures
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Primary Outcome Measures :
  1. Rate of Postoperative complications [ Time Frame: postoperative 1-30 days ]
    postoperative complications after surgery for Crohn's Disease according to clavien-dindo system


Secondary Outcome Measures :
  1. Length of postoperative hospital stay [ Time Frame: from surgery to discharge ]
    postoperative hospital stay after surgery for Crohn's Disease

  2. Blood Concentration of IL-6 [ Time Frame: postoperative 1, 3, and 6 day ]
    Blood Concentration of IL-6 after surgery

  3. Blood Concentration of TNF-α [ Time Frame: postoperative 1, 3, and 6 day ]
    Blood Concentration of TNF-α after surgery

  4. Blood Concentration of IL-1β [ Time Frame: postoperative 1, 3, and 6 day ]
    Blood Concentration of IL-1β after surgery

  5. Blood Concentration of albumin [ Time Frame: postoperative 1, 3, and 6 day ]
    Blood Concentration of albumin after surgery

  6. Blood Concentration of C-reactive protein [ Time Frame: postoperative 1, 3, and 6 day ]
    Blood Concentration of C-reactive protein after surgery

  7. Blood White blood cell level [ Time Frame: postoperative 1, 3, and 6 day ]
    Blood White blood cell level after surgery


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03901937


Contacts
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Contact: Wei Zhou, MD PHD 13588706479 zhouw@srrsh.com

Locations
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China, Zhejiang
Sir Run Run Shaw hospital Recruiting
Hangzhou, Zhejiang, China, 310016
Contact: Xiaolong Ge, PhD    13867106984    gxlnjumed09@126.com   
Sponsors and Collaborators
Sir Run Run Shaw Hospital
Investigators
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Study Chair: Xiujun Cai Sir Run Run Shaw Hospital
More Information
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Responsible Party: Wei Zhou, Clinical Professor, Sir Run Run Shaw Hospital
ClinicalTrials.gov Identifier: NCT03901937    
Other Study ID Numbers: SRRSH20180925-8
First Posted: April 3, 2019    Key Record Dates
Last Update Posted: April 3, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data collection from 2019-3 to 2020-9

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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
Keywords provided by Wei Zhou, Sir Run Run Shaw Hospital:
postoperative complications
Additional relevant MeSH terms:
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Crohn Disease
Postoperative Complications
Inflammatory Bowel Diseases
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Pathologic Processes