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Routine Post-Operative Supplemental Nutrition

Primary Purpose

Esophageal Cancer

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tube Feeding
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Esophageal Cancer focused on measuring Esophageal Cancer, Esophagectomy

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Michigan Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Tube Feeding

Standard of Care

Arm Description

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

Tube feeding to continue in the hospital until the patient is taking adequate nutrition by mouth at post-op day #8, or upon discharge,

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Jejunostomy tube-specific complications
j-tube specific complications include infection, bowel obstruction that may require surgical repair, discomfort, diarrhea and dumping syndrome

Full Information

First Posted
September 11, 2014
Last Updated
August 18, 2020
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT02297607
Brief Title
Routine Post-Operative Supplemental Nutrition
Official Title
Routine Post-Operative Supplemental Nutrition: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Terminated
Why Stopped
Poor accrual. Patients were reluctant to agree if they would need tube feeding for a month.
Study Start Date
November 2014 (Actual)
Primary Completion Date
March 2019 (Actual)
Study Completion Date
May 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer
Keywords
Esophageal Cancer, Esophagectomy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tube Feeding
Arm Type
Experimental
Arm Description
Study subjects will continue to receive tube feedings (for at least 50% of caloric need) for 1-month post-operatively.
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Tube feeding to continue in the hospital until the patient is taking adequate nutrition by mouth at post-op day #8, or upon discharge,
Intervention Type
Dietary Supplement
Intervention Name(s)
Tube Feeding
Other Intervention Name(s)
Boost, Ensure, Nutren 1.0, Osmolite, Replete
Primary Outcome Measure Information:
Title
Quality of Life after surgery
Description
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.
Time Frame
6-months post-operatively
Secondary Outcome Measure Information:
Title
Jejunostomy tube-specific complications
Description
j-tube specific complications include infection, bowel obstruction that may require surgical repair, discomfort, diarrhea and dumping syndrome
Time Frame
2-weeks, 1-month, 3-months and 6-months post-operatively
Other Pre-specified Outcome Measures:
Title
Other post-operative complications
Description
atrial fibrillation, delirium, anastomotic leak, and pneumonia
Time Frame
30-days post-operative
Title
Costs
Description
Cost of care
Time Frame
6-months post-operative
Title
Length of hospital stay
Description
Total length of hospital stay
Time Frame
2-weeks post-operative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip W Carrott, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Routine Post-Operative Supplemental Nutrition

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