NCT03244683

A Study of the Efficacy of ONS to Reduce Postoperative Complications Associated With Pancreatic Surgery

A Study of the Efficacy of Oral Nutritional Supplementation to Reduce Postoperative Complications Associated With Pancreatic Surgery

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Ohio State University · Academic / Other
• Sex: All
• Age: 40 Years – 89 Years
• Healthy volunteers: Not accepted

Summary

This is a single center, open label, randomized trial, involving 150 patients undergoing pancreatic surgery. Patients will be randomized at the time of enrollment to receive from 5-7 days of ONS supplementation combined with resistance training and nutritional education compared to standard of care, consisting of nutritional education alone. This proof of concept study is intended to demonstrate the ability of pre-habilitation to improve patient-related outcomes following pancreatic surgery, specifically postoperative complications. The rationale for using the designated oral nutrient supplementation is to preserve muscle mass, and decrease weight loss.

Detailed description

Patients undergoing pancreatic surgery for either chronic pancreatitis or known/suspected pancreatic cancer represent the study population for this clinical trial. Study subjects randomized to one of the ONS arms will be asked to consume the drink during the study intervention. Study visits immediately preoperative, and 1, 3, and 6 months following surgery will be in-person visits. If subjects are unable to return to our Institution for subsequent clinical care, these telephone interviews will be collected and acquisition of locally obtained laboratory tests will be attempted. Assessments performed during postoperative visits include: * Vital signs and physical examination * Blood samples * Performance status and strength * Quality of life measures * Postoperative complications and hospital readmissions (if any)

Conditions

• Pancreatic Cancer
• Chronic Pancreatitis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Ensure Surgical	Subjects randomized to the intervention arm will consume two Ensure Surgical for 5-7 days.
OTHER	Nutrition counseling	All study subjects will be provided with nutrition counseling at the time of study enrollment.
OTHER	Low-intensity exercise therapy	Patients randomized to the intervention arm will also be provided with verbal and written instructions for light resistance training. The exercises will be performed at home during the preoperative study period.

Timeline

• Start date: 2017-08-28
• Primary completion: 2018-08-01
• Completion: 2018-08-01
• First posted: 2017-08-09
• Last updated: 2021-03-04

Locations

1 site across 1 country: United States