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

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03901937

Acronym

ω3CD

Enrollment

158

Registered

2019-04-03

Start date

2019-03-01

Completion date

2021-03-01

Last updated

2019-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn Disease

Keywords

postoperative complications

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.

Interventions

DRUGω-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).

PROCEDUREIntestinal surgery for Crohn's Disease

Patients receive bowel resection due to complications of Crohn's Disease

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Rate of Postoperative complications	postoperative 1-30 days	postoperative complications after surgery for Crohn's Disease according to clavien-dindo system

Secondary

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

Countries

China

Contacts

Primary ContactWei Zhou, MD PHD

zhouw@srrsh.com13588706479

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026