The PROTEIN study
Research type
Research Study
Full title
A randomized controlled trial of standard or DHA/EPA supplemented enteral nutrition in patients undergoing laparoscopic colorectal surgery PeRioperative Omega Three and the Effect on ImmuNity - PROTEIN Study.
IRAS ID
238410
Contact name
Daniel White
Contact email
Sponsor organisation
Royal Surrey County Hospital
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
The concept of enhanced recovery in surgery was first described by Professor Henrik Kehlet in the late 1990’s. The concept is that of a structured pathway with key pre operative, intraoperative and post operative standardisations of care and opportunities for optimisation all combining to give the best outcome. Since then a vast body of research has invested in developing this pathway. The current enhanced recovery after surgery [ERAS UK] pathway for colorectal resection has 22 elements. Increasing compliance with these elements has shown a cumulative improvement in outcomes when greater than 80% compliance is achieved.
In colorectal resection the evidence for perioperative nutrition is conflicted, mainly due to highly heterogeneous studies combining patients with multiple surgery types: pancreatic,oesophageal, gastric and colorectal. Limited evidence is available for perioperative nutrition, with poor supplement compliance, limited numbers, or heterogeneity being the main study limitations. The evidence becomes even sparser once a purely laparoscopic approach is applied and weaker still when performing the surgery within an enhanced recovery setting as highlighted by a recent meta-analysis. At the time of writing there are currently no papers showing the effect of perioperative immunonutrition on laparoscopic colorectal cancer patients within an enhanced recovery setting.
One of the commonest complications in colorectal resection is post-operative wound infection, comprising up to 25% of patients. This often leads to increased length of hospital stay, increased morbidity, and hospital costs. Multiple meta-analyses and systematic reviews have highlighted the possible benefits of immunonutrition; perioperative supplementation with food supplements enriched with arginine, glutamine, leucine, omega-3 fatty acids in isolation or often in combination. Primary outcomes have been focused on improving wound infection rates and length of hospital stay, but the limitations we have already discussed. It is this void in the literature this research looks to fill.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
18/SC/0191
Date of REC Opinion
30 Apr 2018
REC opinion
Further Information Favourable Opinion