None listed
Conditions
Brief summary
Many patients with Crohn’s disease, an inflammatory bowel disease, will require gastrointestinal surgery to remove diseased parts of their bowel during their lifetime. Malnutrition is common in patients with Crohn’s disease and is an independent risk factor of poor surgical outcomes. Retrospective and uncontrolled studies suggest that 4-6 weeks of exclusive enteral nutrition, a nutritional complete liquid diet, prior to surgery improves nutritional status, reduces gut inflammation and is associated with fewer intraoperative stomas, reduced hospital length of stay and less surgical complications. Currently, there are no prospective randomised controlled trials of exclusive enteral nutrition in patients requiring elective surgery for Crohn’s disease. Significant healthcare savings, and patient quality of life improvements, could result from the use of preoperative exclusive enteral nutrition according to previous cost-benefit analyses. A feasibility randomised controlled trial is proposed to assess the validity of the trial interventions, methods and effectiveness outcomes in the management of Crohn’s disease. Aim 1. To determine whether it is feasible to recruit and retain patients with Crohn’s disease undergoing gastrointestinal surgery in a randomised single-blinded study to compare exclusive enteral nutrition and standard care. Aim 2: To determine whether it is feasible to collect the planned primary and secondary effectiveness objectives. This is a multi-centre feasibility randomised controlled trial of preoperative exclusive enteral nutrition versus standard care in 20-25 patients aged 16+ years requiring elective gastrointestinal surgery for management of their Crohn’s disease. Patients will be recruited from Auckland City area and Christchurch City (including the public and private hospitals) and randomised 1:1, stratified by city, to receive either six weeks of exclusive enteral nutrition, partial enteral nutrition with an exclusion diet or standard care.
Interventions
Patients will be randomised one of three arms for six weeks prior to surgery - exclusive enteral nutrition or partial enteral nutrition with a Crohn's disease exclusion diet or usual care.
Exclusive enteral nutrition provides 100% of a person nutritional requirements and excludes of all other foods and fluids with the exception of water and black tea or coffee. Exclusive enteral nutrition and partial enteral nutrition (50% of nutritional requirements) with a ready to drink polymeric nutrition f
Patients will be randomised one of three arms for six weeks prior to surgery - exclusive enteral nutrition or partial enteral nutrition with a Crohn's disease exclusion diet or usual care. Exclusive enteral nutrition provides 100% of a person nutritional requirements and excludes of all other foods and fluids with the exception of water and black tea or coffee. Exclusive enteral nutrition and partial enteral nutrition (50% of nutritional requirements) with a ready to drink polymeric nutrition formula (e.g. Ensure Plus or Fortisip) will be used for six weeks prior to surgery. Dietary education on how to use exclusive enteral nutrition or partial enteral nutrition with an exclusion diet will be delivered by a New Zealand Registered Dietitian using video consultation and phone follow up and with using existing education resources. The quantity of liquid nutrition drank by each participant will be calculated and monitored by the dietitian and individualised to each patient based on their weight and lifestyle using standard nutrition assessment tools. Adherence to the two enteral nutrition treatments will be monitored by patients counting the number of cartons of remaining each week and reporting this on an electronic form or to the dietitian during 4 telephone follow up calls during the six week treatment. Patients will also be asked to self-report any deviations from enteral nutrition treatment protocols.
Sponsors
University of Otago
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adults over 16 years old with diagnosed Crohn's disease who have consented to have elective gastrointestinal resection for the management of Crohn's disease.
Exclusion criteria
Patients with Crohn’s disease requiring emergency surgery or surgery within 6 weeks Currently has a stoma – may affect study outcomes Requires pre-operative parenteral nutrition. This patient group are unlikely to tolerate the usual care intervention Patients at high risk of malnutrition defined as BMI < 18.5 and greater than 10% body weight loss in last 6 months – malnutrition independently affects surgical outcomes. Patients who cannot attend the baseline and pre-surgical assessment appointments – this would result in incomplete secondary outcomes data collection Does not speak English
Outcome results
None listed