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

• ClinicalTrials.gov Identifier: NCT03901937
• Recruitment Status: Unknown
• First Posted: April 3, 2019
• Last Update Posted: April 3, 2019
• Sponsor: Sir Run Run Shaw Hospital
• Information provided by (Responsible Party): Wei Zhou, Sir Run Run Shaw Hospital

Tracking Information

• First Submitted Date: March 12, 2019
• First Posted Date: April 3, 2019
• Last Update Posted Date: April 3, 2019
• Actual Study Start Date: March 1, 2019
• Estimated Primary Completion Date: September 1, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 2, 2019)

Rate of Postoperative complications [ Time Frame: postoperative 1-30 days ]

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

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: April 2, 2019)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Effects of Parenteral ω-3 Polyunsaturated Fatty Acid on Postoperative Complications of Patients With Crohn's Disease
• Official Title: Department of General Surgery, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, 310016, China
• 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 Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention
• Condition: Crohn Disease

Intervention

• 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

Study Arms

• Placebo Comparator: Placebo
  parenteral nutrition without ω-3 polyunsaturated fatty acid
  Interventions:

  • Drug: ω-3 polyunsaturated fatty acid
  • Procedure: Intestinal surgery for Crohn's Disease
• Experimental: ω-3 fatty acid
  parenteral nutrition with ω-3 polyunsaturated fatty acid
  Intervention: Procedure: Intestinal surgery for Crohn's Disease

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: April 2, 2019): 158
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 1, 2021
• Estimated Primary Completion Date: September 1, 2020 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT03901937
• Other Study ID Numbers: SRRSH20180925-8
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

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

• Current Responsible Party: Wei Zhou, Sir Run Run Shaw Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Sir Run Run Shaw Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Chair: Xiujun Cai; Sir Run Run Shaw Hospital

• PRS Account: Sir Run Run Shaw Hospital
• Verification Date: April 2019