PeRioperative Omega Three and the Effect on ImmuNity (PROTEIN)
|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: NCT03598413|
Recruitment Status : Unknown
Verified August 2018 by Daniel White, Royal Surrey County Hospital NHS Foundation Trust.
Recruitment status was: Recruiting
First Posted : July 26, 2018
Last Update Posted : August 29, 2018
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Nutritional Deficiency Infected Wound Surgical Site Infection Complication, Postoperative Surgery Surgery--Complications Sarcopenia Phagocytic Dysfunction||Dietary Supplement: Omega-3||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Prospective Randomised controlled trial|
|Masking Description:||Single blind trial, analysis of all samples blinded to investigation team.|
|Official Title:||A Randomized Controlled Trial of Standard or DHA/EPA Supplemented Enteral Nutrition in Patients Undergoing Laparoscopic Colorectal Surgery|
|Actual Study Start Date :||July 16, 2018|
|Estimated Primary Completion Date :||October 5, 2019|
|Estimated Study Completion Date :||December 5, 2019|
No Intervention: Control
Patients undergoing standard laparoscopic colorectal resection with no omega-3 enriched peri-operative nutritional support
Patients in this group will receive 7 days pre and 7 days post surgery of a nutritional supplement enriched with 1.42g/dose of the fish oils EPA and DHA. The supplement is pre-mixed and will be taken twice daily for a total of 14 days.
Dietary Supplement: Omega-3
200ml, pre-mixed oral nutritional supplement supplying 1.42g per bottle of EPA and DHA.
- Changes in Phagocytosis of pathogens [ Time Frame: Baseline [2-4 weeks before surgery], Day of Surgery [day 7 post nutritional supplementation], Day 1 post surgery [day 8 post supplementation]. ]Phagocytosis of E.Coli, S.Aureus and Candida measured with flow cytometry
- Changes in cell membrane composition [ Time Frame: Baseline [2-4 weeks before surgery], Day of Surgery [day 7 post nutritional supplementation], Day 1 post surgery [day 8 post supplementation]. ]Using gas chromatography, measuring the percentage of omega-3 within cell membranes
- Infectious complications [ Time Frame: 30 days ]Descriptions laid out in supplement 1 for diagnostic criteria
- Non-infectious complications [ Time Frame: 30 days ]Descriptions laid out in supplement 1 for diagnostic criteria
- Length of hospital stay [ Time Frame: A maximum of 90 days ]Length of stay in days as per electronic discharge records
- Sarcopenia [ Time Frame: Baseline [Pre-operative staging CT scan] and 6 month +/-2 months ]Changes in body composition measured on CT scan
- Quality of Life (EORTC: QLQC30) [ Time Frame: Baseline and 3 weeks post surgery +/- 7 days ]Quality of life questionnaire EORTC: QLQC30. A 30 element validated questionnaire. Symptoms are grouped into scales: Physical Function, Role Function, Emotional Function, Cognitive Function, and Social Function. In addition symptom scales including: Fatigue, Nausea, vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhoea, and financial difficulties. 28 of the scales range from 1 to 4, 4 being most symptomatic, 1 least so. The 2 remaining scales for overall health and quality of life are scaled 1-7, with 7 being the best and 1 the worst. The 30 questions can be combined for a global score, in which instance the 2 global scales are reversed so that 7 becomes the worst quality of life or health and 1 the best.
- Changes in Hand grip strength [ Time Frame: Baseline [Pre-operative staging CT scan] and 6 month +/-2 months ]Physical measurement of hand grip strength using hand dyanamometer to assist in diagnosis of sarcopenia / functional status.
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): NCT03598413
|Contact: Daniel White, MBBSfirstname.lastname@example.org|
|Royal Surrey County Hospital||Recruiting|
|Guildford, Surrey, United Kingdom, GU2 7WG|
|Contact: Daniel White, MBBS 01483688691 email@example.com|