Clinical trial NCT03333148: Preoperative Oral ImmunoNuTrition to Improve Surgical Outcomes for IBD Patients (PINT)
Official title: Preoperative Oral ImmunoNuTrition to Improve Surgical Outcomes for Inflammatory Bowel Disease Patients (PINT): A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Inflammatory Bowel Diseases
Keywords: Colorectal Surgery
Immunonutrition
Complications
Microbiome
Preoperative nutrition
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2017-11-06
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* ≥19 years of age
* All races and all genders
* Confirmed diagnosis and history of IBD
* ESPEN Nutritional Risk Scores \>=3 and the ESPEN Disease Severity sub-score \< 3
* Scheduled for elective surgery via any transabdominal operative approach (i.e. laparoscopic, hand-assisted, robotic, open) with a planned postoperative inpatient stay of at least one night

Exclusion Criteria:

* Failure to meet eligibility criteria
* Patients requiring emergency surgical intervention
* Patients with an American Society of Anesthesiologist physical status of IV or V
* Patients requiring hemodialysis
* Patients with history of myocardial infarction within 6 months
* Patients with a history of asthma
* Patients with cirrhosis or a history of liver disease
* Patients with a present history of dysphagia, pyloric stenosis and esophageal strictures
* Patients unable to consume liquids orally
* Patients allergic or with hypersensitivity reactions to any of the components of the Nestlé IMPACT-Advanced Recovery immunonutritional supplement
* Patients with a history of galactosemia, the inability to metabolize the sugar galactose appropriately
* Patients with bowel obstructions
* Patients with history of HIV or of solid-organ transplant
* Patients who are pregnant or breastfeeding

Primary outcomes:
measure: The occurrence of any postoperative complications after surgery
timeFrame: Baseline (day of surgery) to 2 weeks (after surgery)
measure: The occurrence of any postoperative complications after surgery
timeFrame: Baseline (day of surgery) to 30 days (after surgery)
measure: The occurrence of any postoperative complications after surgery
timeFrame: Baseline (day of surgery) to 60 days (after surgery)
Secondary outcomes:
measure: Detection of the differences in the markers of inflammation interleukin-1-β (IL-1β)
timeFrame: Baseline (preoperative visit)
measure: Detection of the differences in the markers of inflammation interleukin-1-β (IL-1β)
timeFrame: Baseline (preoperative visit) to day of surgery
measure: Detection of the differences in the markers of inflammation interleukin-1-β (IL-1β)
timeFrame: Baseline (preoperative visit) to postoperative day 3
measure: Detection of the differences in the markers of inflammation Interleukin 6 (IL-6)
timeFrame: Baseline (preoperative visit)
measure: Detection of the differences in the markers of inflammation Interleukin 6 (IL-6)
timeFrame: Baseline (preoperative visit) to day of surgery
measure: Detection of the differences in the markers of inflammation Interleukin 6 (IL-6)
timeFrame: Baseline (preoperative visit) to postoperative day 3
measure: Detection of the differences in the markers of inflammation tumor necrosis factor (TNF-α)
timeFrame: Baseline (preoperative visit)
measure: Detection of the differences in the markers of inflammation tumor necrosis factor (TNF-α)
timeFrame: Baseline to day of surgery
measure: Detection of the differences in the markers of inflammation tumor necrosis factor (TNF-α)
timeFrame: Baseline (preoperative visit) to postoperative day 3
measure: Detection of the differences in the markers of inflammation CRP
timeFrame: Baseline (preoperative visit)
measure: Detection of the differences in the markers of inflammation CRP
timeFrame: Baseline (preoperative visit) to day of surgery
measure: Detection of the differences in the markers of inflammation CRP
timeFrame: Baseline (preoperative visit) to postoperative day 3
measure: Detection of the differences in the markers of inflammation nutritional status albumin
timeFrame: Baseline (preoperative visit)
measure: Detection of the differences in the markers of inflammation nutritional status albumin
timeFrame: Baseline (preoperative visit) to day of surgery
measure: Detection of the differences in the markers of inflammation nutritional status albumin
timeFrame: Baseline (preoperative visit) to postoperative day 3
measure: Detection of the differences in the markers of inflammation pre-albumin
timeFrame: Baseline (preoperative visit)
measure: Detection of the differences in the markers of inflammation pre-albumin
timeFrame: Baseline (preoperative visit) to day of surgery
measure: Detection of the differences in the markers of inflammation pre-albumin
timeFrame: Baseline (preoperative visit) to postoperative day 3
Other outcomes:
measure: Length of hospital stay (LOS)
timeFrame: Baseline (Day of surgery) to day of discharge (approximately 2 to 30 days post surgery)
measure: Patient Quality of Life (QOL)
timeFrame: Baseline (preoperative visit)
measure: Patient Quality of Life (QOL)
timeFrame: Baseline (preoperative) to 30 days
measure: Patient Satisfaction (S-CAHPS)
timeFrame: Baseline (Preoperative)
measure: Patient Satisfaction (S-CAHPS)
timeFrame: Postoperative (After Surgery)
measure: Detection of differences in fecal microbiome
timeFrame: Baseline (Preoperative)
measure: Detection of differences in fecal microbiome
timeFrame: Day of Surgery
measure: Detection of differences in fecal microbiome
timeFrame: 2 weeks after surgery (postoperative visit)
Locations:
Study officials:
affiliation: University of Alabama at Birmingham
name: Gregory D Kennedy, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: