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

Crohn Disease Clinical Trial

— ?3CD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03901937
• Other study ID #: SRRSH20180925-8
• Status: Recruiting
• Phase: Phase 4
• Start date: March 1, 2019
• Est. completion date: March 1, 2021

Study information

• Verified date: April 2019
• Source: Sir Run Run Shaw Hospital
• Contact: Wei Zhou, MD PHD
• Phone: 13588706479
• Email: zhouw[@]srrsh.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 158
• Est. completion date: March 1, 2021
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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 ?-3 polyunsaturated fatty acid.

Related Conditions & MeSH terms

• Crohn Disease
• Postoperative Complications

Intervention

Drug:
• ?-3 polyunsaturated fatty acid
CD patients are divided into two groups, which include with and without ?-3 polyunsaturated fatty acid-based PN (0.1-0.2g/kg/d).

Procedure:
• Intestinal surgery for Crohn's Disease
Patients receive bowel resection due to complications of Crohn's Disease

Locations

Country	Name	City	State
China	Sir Run Run Shaw hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Sir Run Run Shaw Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Postoperative complications	postoperative complications after surgery for Crohn's Disease according to clavien-dindo system	postoperative 1-30 days
Secondary	Length of postoperative hospital stay	postoperative hospital stay after surgery for Crohn's Disease	from surgery to discharge
Secondary	Blood Concentration of IL-6	Blood Concentration of IL-6 after surgery	postoperative 1, 3, and 6 day
Secondary	Blood Concentration of TNF-a	Blood Concentration of TNF-a after surgery	postoperative 1, 3, and 6 day
Secondary	Blood Concentration of IL-1ß	Blood Concentration of IL-1ß after surgery	postoperative 1, 3, and 6 day
Secondary	Blood Concentration of albumin	Blood Concentration of albumin after surgery	postoperative 1, 3, and 6 day
Secondary	Blood Concentration of C-reactive protein	Blood Concentration of C-reactive protein after surgery	postoperative 1, 3, and 6 day
Secondary	Blood White blood cell level	Blood White blood cell level after surgery	postoperative 1, 3, and 6 day