Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
30 participants
INTERVENTIONAL
2014-11-30
2019-05-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Tube Feeding
Study subjects will continue to receive tube feedings (for at least 50% of caloric need) for 1-month post-operatively.
Tube Feeding
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,
No interventions assigned to this group
Interventions
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Tube Feeding
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Jejunal feeding tube placed at the time of surgery
Exclusion Criteria
* Inability to provide informed consent or to complete testing or data collection
* Unwillingness to be randomized
* Tube feeding dependent on discharge
18 Years
99 Years
ALL
No
Sponsors
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University of Michigan
OTHER
Responsible Party
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Philip W. Carrott, Jr.
Assistant Professor of Thoracic Surgery, Medical School
Principal Investigators
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Philip W Carrott, MD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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University of Michigan Health System
Ann Arbor, Michigan, United States
Countries
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Provided Documents
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Document Type: Informed Consent Form
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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HUM00091994
Identifier Type: -
Identifier Source: org_study_id
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