Routine Post-Operative Supplemental Nutrition

NCT02297607 | Terminated

• 1 other identifier: HUM00091994
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Cancer

Keywords

Esophageal Cancer; Esophagectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Jejunostomy tube-specific complications

  2-weeks, 1-month, 3-months and 6-months post-operatively

Other Outcomes (3)

• Other post-operative complications

  30-days post-operative

• Costs

  6-months post-operative

• Length of hospital stay

  2-weeks post-operative

Study Arms (2)

Tube Feeding

EXPERIMENTAL

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

Dietary Supplement: Tube Feeding

Standard of Care

NO INTERVENTION

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

Interventions

Tube Feeding DIETARY_SUPPLEMENT

Also known as: Boost, Ensure, Nutren 1.0, Osmolite, Replete

Tube Feeding

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Emergent esophagectomy procedure
• Inability to provide informed consent or to complete testing or data collection
• Unwillingness to be randomized
• Tube feeding dependent on discharge

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Enteral Nutrition; Osmolite

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Feeding Methods; Therapeutics; Nutritional Support; Nutrition Therapy

Study Officials

• Philip W Carrott, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Thoracic Surgery, Medical School

Study Record Dates

• First Submitted: September 11, 2014
• First Posted: November 21, 2014
• Study Start: November 1, 2014
• Primary Completion: March 1, 2019
• Study Completion: May 1, 2019
• Last Updated: August 27, 2020

Record last verified: 2020-08

Locations

US (1)