Routine Post-Operative Supplemental Nutrition

Esophageal Cancer Clinical Trial

Official title:

Routine Post-Operative Supplemental Nutrition: A Randomized Controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02297607
• Other study ID #: HUM00091994
• Status: Terminated
• Phase: N/A
• Start date: November 2014
• Est. completion date: May 2019

Study information

• Verified date: August 2020
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: May 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Dietary Supplement:
• Tube Feeding

Locations

Country	Name	City	State
United States	University of Michigan Health System	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

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