Routine Post-Operative Supplemental Nutrition
- Conditions
- Esophageal Cancer
- Registration Number
- NCT02297607
- Lead Sponsor
- University of Michigan
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 30
- Patients undergoing an elective esophagectomy
- Jejunal feeding tube placed at the time of surgery
- Emergent esophagectomy procedure
- Inability to provide informed consent or to complete testing or data collection
- Unwillingness to be randomized
- Tube feeding dependent on discharge
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
University of Michigan Health System
🇺🇸Ann Arbor, Michigan, United States
University of Michigan Health System🇺🇸Ann Arbor, Michigan, United States