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

NCT03244683 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2021-03-04

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Abbott Nutrition

    collaborator INDUSTRY

  • Ohio State University

    lead OTHER

Principal Investigators

  • Philip Hart, MD · Ohio State University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-28
Primary Completion
2018-08-01
Completion
2018-08-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03244683 on ClinicalTrials.gov