Esophageal Cancer
Conditions
Keywords
Esophageal Cancer, Esophagectomy
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTTube Feeding
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Patients undergoing an elective esophagectomy * Jejunal feeding tube placed at the time of surgery
Exclusion criteria
* Emergent esophagectomy procedure * Inability to provide informed consent or to complete testing or data collection * Unwillingness to be randomized * Tube feeding dependent on discharge
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life after surgery | 6-months post-operatively | Quality of Life will be assessed using the EORTC QLQ-30 Survey Instrument. Post-operative QOL assessment will be compared to baseline (prior to surgery) QOL assessment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Jejunostomy tube-specific complications | 2-weeks, 1-month, 3-months and 6-months post-operatively | j-tube specific complications include infection, bowel obstruction that may require surgical repair, discomfort, diarrhea and dumping syndrome |
Other
| Measure | Time frame | Description |
|---|---|---|
| Other post-operative complications | 30-days post-operative | atrial fibrillation, delirium, anastomotic leak, and pneumonia |
| Costs | 6-months post-operative | Cost of care |
| Length of hospital stay | 2-weeks post-operative | Total length of hospital stay |
Countries
United States
Outcome results
None listed