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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03901937 |
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Date of registration:
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12/03/2019 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The Effects of Parenteral ?-3 Polyunsaturated Fatty Acid on Postoperative Complications of Patients With Crohn's Disease
?3CD |
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Scientific title:
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Department of General Surgery, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, 310016, China |
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Date of first enrolment:
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March 1, 2019 |
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Target sample size:
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158 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03901937 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 4
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Countries of recruitment
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China
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Contacts
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Name:
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Xiaolong Ge, PhD |
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Address:
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Telephone:
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13867106984 |
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Email:
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gxlnjumed09@126.com |
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Affiliation:
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Name:
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Wei Zhou, MD PHD |
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Address:
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Telephone:
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13588706479 |
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Email:
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zhouw@srrsh.com |
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Affiliation:
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Name:
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Xiujun Cai |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sir Run Run Shaw Hospital |
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Key inclusion & exclusion 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
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 ?-3 polyunsaturated fatty acid.
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Crohn Disease
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Intervention(s)
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Procedure: Intestinal surgery for Crohn's Disease
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Drug: ?-3 polyunsaturated fatty acid
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Primary Outcome(s)
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Rate of Postoperative complications
[Time Frame: postoperative 1-30 days]
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Secondary Outcome(s)
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Blood Concentration of albumin
[Time Frame: postoperative 1, 3, and 6 day]
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Blood Concentration of IL-1ß
[Time Frame: postoperative 1, 3, and 6 day]
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Blood Concentration of IL-6
[Time Frame: postoperative 1, 3, and 6 day]
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Length of postoperative hospital stay
[Time Frame: from surgery to discharge]
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Blood Concentration of TNF-a
[Time Frame: postoperative 1, 3, and 6 day]
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Blood Concentration of C-reactive protein
[Time Frame: postoperative 1, 3, and 6 day]
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Blood White blood cell level
[Time Frame: postoperative 1, 3, and 6 day]
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Secondary ID(s)
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SRRSH20180925-8
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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