The central focus of this trial is to understand the effectiveness of Preoperative Immunonutrition (PINT) in improving surgical outcomes for patients with inflammatory bowel disease (IBD). We hypothesize that PINT will reduce post-operative complications in IBD patients undergoing elective surgery with added improvements in length-of-stay (LOS), quality of life (QOL) and patient satisfaction. As a secondary focus, the investigator will aim to better understand the potential mechanism-of-action by which PINT may have its effects through analyses of biomarkers including inflammatory markers, nutritional proteins and the fecal microbiome.
Inflammatory bowel disease (IBD), which includes Crohn's and Ulcerative Colitis, is a chronic and costly disease of unknown etiology that now affects over 3.1 million people in the United States. Patients with IBD suffer from lifelong malnutrition, pain and bleeding with added risks of cancers, obstructions and fistulas. There is no known cure and the incidence continues to grow. While treatments are usually medical IBD patients will undergo at least one major surgery during their lifetime. Patients also have particularly poor surgical outcomes with high rates of post-operative complications. In an attempt to improve the risk profile of patients and decrease complications, preoperative total parenteral nutrition (TPN) has been used to optimize IBD patients for surgery. While this approach has been successful the cost and morbidities of TPN prohibit its generalized application. Practical strategies that improve surgical outcomes for IBD patients are urgently needed. Improving nutritional deficiencies before an operation may be a practical way to improve post-operative outcomes. The oral administration of preoperative immunonutrition, is an alternative method to improve nutritional states and may have utility in IBD patients who have particularly severe nutritional deficiencies because of disease-specific issues in malabsorption, maldigestion and loss of appetite.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Along with standard of care nutritional therapy patients (n=146) will be asked to consume 3 cartons/day for 14 days of Nestle IMPACT Advanced Recovery Immunonutrition.
No intervention standard of care nutrition (n=146).
The occurrence of any postoperative complications after surgery
Routine postoperative follow-up for all patients will occur at 2 weeks post discharge. Any serious adverse events or adverse events will be ascertained at the 2 week follow up visit. Complication rates will be divided into major and minor postoperative complications and will be defined as any deviation from the normal postoperative recovery process. Complications will be assessed using the Clavien-Dindo classification in minor and major.
Time frame: Baseline (day of surgery) to 2 weeks (after surgery)
The occurrence of any postoperative complications after surgery
At the 30 day post-discharge postoperative follow up visit, serious adverse events will be ascertained that may have occurred after the 2 week follow up visit. Patients who are unable to return on the 30-day mark will be called to screen for any post-discharge complications. Complication rates will be divided into major and minor postoperative complications and will be defined as any deviation from the normal postoperative recovery process. Complications will be assessed using the Clavien-Dindo classification in minor and major.
Time frame: Baseline (day of surgery) to 30 days (after surgery)
The occurrence of any postoperative complications after surgery
Final call to ascertain complications will be at 60 days. Complication rates will be divided into major and minor postoperative complications and will be defined as any deviation from the normal postoperative recovery process. Complications will be assessed using the Clavien-Dindo classification in minor and major.
Time frame: Baseline (day of surgery) to 60 days (after surgery)
Detection of the differences in the markers of inflammation interleukin-1-β (IL-1β)
Enzyme-linked immunosorbent assays (ELISA) will be performed to assess whole blood, plasma and serum samples for circulating inflammatory cytokine interleukin-1-β (IL-1β.
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Time frame: Baseline (preoperative visit)
Detection of the differences in the markers of inflammation interleukin-1-β (IL-1β)
Enzyme-linked immunosorbent assays (ELISA) will be performed to assess whole blood, plasma and serum samples for circulating inflammatory cytokine interleukin-1-β (IL-1β.
Time frame: Baseline (preoperative visit) to day of surgery
Detection of the differences in the markers of inflammation interleukin-1-β (IL-1β)
Enzyme-linked immunosorbent assays (ELISA) will be performed to assess whole blood, plasma and serum samples for circulating inflammatory cytokine interleukin-1-β (IL-1β.
Time frame: Baseline (preoperative visit) to postoperative day 3
Detection of the differences in the markers of inflammation Interleukin 6 (IL-6)
Enzyme-linked immunosorbent assays (ELISA) will be performed to assess whole blood, plasma and serum samples for circulating inflammatory cytokine interleukin-6 (IL-6).
Time frame: Baseline (preoperative visit)
Detection of the differences in the markers of inflammation Interleukin 6 (IL-6)
Enzyme-linked immunosorbent assays (ELISA) will be performed to assess whole blood, plasma and serum samples for circulating inflammatory cytokine interleukin-6 (IL-6).
Time frame: Baseline (preoperative visit) to day of surgery
Detection of the differences in the markers of inflammation Interleukin 6 (IL-6)
Enzyme-linked immunosorbent assays (ELISA) will be performed to assess whole blood, plasma and serum samples for circulating inflammatory cytokine interleukin-6 (IL-6).
Time frame: Baseline (preoperative visit) to postoperative day 3
Detection of the differences in the markers of inflammation tumor necrosis factor (TNF-α)
Enzyme-linked immunosorbent assays (ELISA) will be performed to assess whole blood, plasma and serum samples for circulating tumor necrosis factor (TNF-α).
Time frame: Baseline (preoperative visit)
Detection of the differences in the markers of inflammation tumor necrosis factor (TNF-α)
Enzyme-linked immunosorbent assays (ELISA) will be performed to assess whole blood, plasma and serum samples for circulating tumor necrosis factor (TNF-α).
Time frame: Baseline to day of surgery
Detection of the differences in the markers of inflammation tumor necrosis factor (TNF-α)
Enzyme-linked immunosorbent assays (ELISA) will be performed to assess whole blood, plasma and serum samples for circulating tumor necrosis factor (TNF-α).
Time frame: Baseline (preoperative visit) to postoperative day 3
Detection of the differences in the markers of inflammation CRP
Immunoassays will be performed with high sensitivity nephelometry to measure CRP levels.
Time frame: Baseline (preoperative visit)
Detection of the differences in the markers of inflammation CRP
Immunoassays will be performed with high sensitivity nephelometry to measure CRP levels.
Time frame: Baseline (preoperative visit) to day of surgery
Detection of the differences in the markers of inflammation CRP
Immunoassays will be performed with high sensitivity nephelometry to measure CRP levels.
Time frame: Baseline (preoperative visit) to postoperative day 3
Detection of the differences in the markers of inflammation nutritional status albumin
Comprehensive metabolic panels will be ordered to assess levels of serum albumin
Time frame: Baseline (preoperative visit)
Detection of the differences in the markers of inflammation nutritional status albumin
Comprehensive metabolic panels will be ordered to assess levels of serum albumin
Time frame: Baseline (preoperative visit) to day of surgery
Detection of the differences in the markers of inflammation nutritional status albumin
Comprehensive metabolic panels will be ordered to assess levels of serum albumin
Time frame: Baseline (preoperative visit) to postoperative day 3
Detection of the differences in the markers of inflammation pre-albumin
Comprehensive metabolic panels will be ordered to assess levels of serum pre-albumin
Time frame: Baseline (preoperative visit)
Detection of the differences in the markers of inflammation pre-albumin
Comprehensive metabolic panels will be ordered to assess levels of serum pre-albumin
Time frame: Baseline (preoperative visit) to day of surgery
Detection of the differences in the markers of inflammation pre-albumin
Comprehensive metabolic panels will be ordered to assess levels of serum pre-albumin
Time frame: Baseline (preoperative visit) to postoperative day 3