Routine Post-Operative Supplemental Nutrition

Study Overview
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Brief Summary
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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.

Official Title
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Routine Post-Operative Supplemental Nutrition: A Randomized Controlled Trial

Conditions
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Esophageal Cancer

Intervention / Treatment
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* Dietary Supplement: Tube Feeding


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tube Feeding<br>Study subjects will continue to receive tube feedings (for at least 50% of caloric need) for 1-month post-operatively. | Dietary Supplement: Tube Feeding<br> <br> * Other names: Replete;|
| No Intervention: Standard of Care<br>Tube feeding to continue in the hospital until the patient is taking adequate nutrition by mouth at post-op day #8, or upon discharge, | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life after surgery | 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. | 6-months post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Jejunostomy tube-specific complications | j-tube specific complications include infection, bowel obstruction that may require surgical repair, discomfort, diarrhea and dumping syndrome | 2-weeks, 1-month, 3-months and 6-months post-operatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Esophageal Cancer, Esophagectomy