Routine Post-Operative Supplemental Nutrition

Not Applicable

Terminated

• Conditions: Esophageal Cancer
• Interventions: Dietary Supplement: Tube Feeding

• 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

Study Timeline

• Study First Submitted: 2014-09-11
• Study Start: 2014-11
• Study First Submitted QC: 2014-11-18
• Study First Posted: 2014-11-21
• Primary Completion: 2019-03
• Study Completion: 2019-05
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-18
• Last Update Posted: 2020-08-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients undergoing an elective esophagectomy
• Jejunal feeding tube placed at the time of surgery

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tube Feeding	Tube Feeding	Study subjects will continue to receive tube feedings (for at least 50% of caloric need) for 1-month post-operatively.

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