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Routine Post-Operative Supplemental Nutrition

Sponsor
University of Michigan (Other)
Overall Status
Terminated
CT.gov ID
NCT02297607
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
53.9
Actual Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Tube Feeding
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Routine Post-Operative Supplemental Nutrition: A Randomized Controlled Trial
Actual Study Start Date :
Nov 1, 2014
Actual Primary Completion Date :
Mar 1, 2019
Actual Study Completion Date :
May 1, 2019

Arms and Interventions

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:
  • Boost
  • Ensure
  • 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,

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    Other Outcome Measures

    1. Other post-operative complications [30-days post-operative]

      atrial fibrillation, delirium, anastomotic leak, and pneumonia

    2. Costs [6-months post-operative]

      Cost of care

    3. Length of hospital stay [2-weeks post-operative]

      Total length of hospital stay

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Michigan Health System Ann Arbor Michigan United States 48109

    Sponsors and Collaborators

    • University of Michigan

    Investigators

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

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Philip W. Carrott, Jr., Assistant Professor of Thoracic Surgery, Medical School, University of Michigan
    ClinicalTrials.gov Identifier:
    NCT02297607
    Other Study ID Numbers:
    • HUM00091994
    First Posted:
    Nov 21, 2014
    Last Update Posted:
    Aug 27, 2020
    Last Verified:
    Aug 1, 2020
    Keywords provided by Philip W. Carrott, Jr., Assistant Professor of Thoracic Surgery, Medical School, University of Michigan
    Esophageal Cancer
    Esophagectomy
    Additional relevant MeSH terms:
    Esophageal Neoplasms

    Study Results

    No Results Posted as of Aug 27, 2020