Status:
WITHDRAWN
Preoperative Oral ImmunoNuTrition to Improve Surgical Outcomes for IBD Patients (PINT)
Lead Sponsor:
University of Alabama at Birmingham
Conditions:
Inflammatory Bowel Diseases
Eligibility:
All Genders
19+ years
Phase:
EARLY_PHASE1
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 hypothes...
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. Pati...
Eligibility Criteria
Inclusion
- ≥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
- 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
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03333148
Start Date
June 1 2020
End Date
January 1 2022
Last Update
August 17 2020
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