Routine Post-Operative Supplemental Nutrition

Stopped early · Not applicable

Conditions studied: Esophageal Cancer

In brief

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.

Key facts

Study ID

NCT02297607

Run by

University of Michigan

People needed

30

Starts

2014-11-01

Expected to finish

2019-05-01

Last updated by the study team

2020-08-27

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients undergoing an elective esophagectomy
• Jejunal feeding tube placed at the time of surgery

You may not qualify if…

• Emergent esophagectomy procedure
• Inability to provide informed consent or to complete testing or data collection
• Unwillingness to be randomized
• Tube feeding dependent on discharge

Where it is running

• University of Michigan Health System — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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