Routine Post-Operative Supplemental Nutrition

University of Michigan

Status: Terminated

Conditions: Esophageal Cancer

Treatments: Dietary Supplement: Tube Feeding

Study type: Interventional

Funder types: Other

Identifiers

NCT02297607

HUM00091994

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

30 participants in 2 patient groups

Tube Feeding

Experimental group

Description:

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

Treatment:

Dietary Supplement: Tube Feeding

Standard of Care

No Intervention group

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,