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Poor accrual. Patients were reluctant to agree if they would need tube feeding for a month.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tube Feeding | Experimental | Study subjects will continue to receive tube feedings (for at least 50% of caloric need) for 1-month post-operatively. |
|
| Standard of Care | No 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, |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tube Feeding | Dietary Supplement |
|
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Other post-operative complications | atrial fibrillation, delirium, anastomotic leak, and pneumonia | 30-days post-operative |
| Costs | Cost of care |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philip W Carrott, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Health System | Ann Arbor | Michigan | 48109 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Oct 29, 2015 | Feb 24, 2020 | ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 16, 2014 | Jul 8, 2020 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D004750 | Enteral Nutrition |
| C080652 | Osmolite |
| ID | Term |
|---|---|
| D005248 | Feeding Methods |
| D013812 | Therapeutics |
| D018529 | Nutritional Support |
| D044623 | Nutrition Therapy |
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| 6-months post-operative |
| Length of hospital stay | Total length of hospital stay | 2-weeks post-operative |
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |