Routine Post-Operative Supplemental Nutrition

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.

Study Overview

• Status: Terminated
• Conditions: Esophageal Cancer
• Intervention / Treatment: Dietary supplement: Tube Feeding

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Tube Feeding; Study subjects will continue to receive tube feedings (for at least 50% of caloric need) for 1-month post-operatively.	Dietary supplement: Tube Feeding; Other Names: Ensure; Boost; Nutren 1.0; Osmolite; Replete
NO_INTERVENTION: Standard of Care; 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?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Other post-operative complications	atrial fibrillation, delirium, anastomotic leak, and pneumonia	30-days post-operative
Costs	Cost of care	6-months post-operative
Length of hospital stay	Total length of hospital stay	2-weeks post-operative

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Philip W Carrott, MD, University of Michigan

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2014
• Primary Completion (ACTUAL): March 1, 2019
• Study Completion (ACTUAL): May 1, 2019

Study Registration Dates

• First Submitted: September 11, 2014
• First Submitted That Met QC Criteria: November 18, 2014
• First Posted (ESTIMATE): November 21, 2014

Study Record Updates

• Last Update Posted (ACTUAL): August 27, 2020
• Last Update Submitted That Met QC Criteria: August 18, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Esophageal Cancer; Esophagectomy
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms
• Other Study ID Numbers: HUM00091994