Routine Post-Operative Supplemental Nutrition
Status: | Active, not recruiting |
---|---|
Conditions: | Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 6/9/2018 |
Start Date: | November 2014 |
End Date: | April 2020 |
Routine Post-Operative Supplemental Nutrition: A Randomized Controlled 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.
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.
Inclusion Criteria:
- Patients undergoing an elective esophagectomy
- Jejunal feeding tube placed at the time of surgery
Exclusion Criteria:
- Emergent esophagectomy procedure
- Less than 18-years of age
- Inability to provide informed consent or to complete testing or data collection
- Unwillingness to be randomized
- Tube feeding dependent on discharge
We found this trial at
1
site
1500 E Medical Center Dr
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
(734) 936-4000
Phone: 734-936-4561
University of Michigan Health System The University of Michigan is home to one of the...
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