Overseen byPhilip W Carrott, MD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Waitlist Available
Sponsor: University of Michigan
No Placebo Group
Trial Summary
What is the purpose of this trial?Patients undergoing an esophagectomy will be randomized to receive either (1) routine post-operative tube feeding for 1 month post-operative or (2) usual practice, which is tube feeding to continue in the hospital until the patient is taking adequate nutrition by mouth at POD#8, or upon discharge.
Specific Aim 1 is to determine the occurrence of common complications and readmissions post-operatively between the two patient groups. The investigators hypothesize that routine use of tube feeding may reduce the occurrence of post-operative complications.
Specific Aim 2 is to determine if routine dietary supplementation with enteral tube affects recovery and QOL after esophagectomy. The investigators hypothesize that routine post-operative supplementation will enhance patients recovery and QOL.
For esophagectomy specifically, there is very limited literature evaluating the complication rate and QOL associated with the length of post-operative tube feeding and adequate nutritional requirements. Small randomized studies have not shown a benefit to routine tube feeding, although the numbers were very small, ranging from 12-70 per group. The investigators will randomize 200 patients for the purpose of this study.
Eligibility Criteria
Treatment Details
2Treatment groups
Experimental Treatment
Active Control
Group I: Tube FeedingExperimental Treatment1 Intervention
Study subjects will continue to receive tube feedings (for at least 50% of caloric need) for 1-month post-operatively.
Group II: Standard of CareActive Control1 Intervention
Tube feeding to continue in the hospital until the patient is taking adequate nutrition by mouth at post-op day #8, or upon discharge,
Find a clinic near you
Research locations nearbySelect from list below to view details:
University of Michigan Health SystemAnn Arbor, MI
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Who is running the clinical trial?
University of MichiganLead Sponsor