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

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Brief Title

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

Official Title

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

Brief 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)
    


Study Type

Interventional


Primary Outcome

Postoperative complications

Secondary Outcome

 Supplement compliance

Condition

Pancreatic Cancer

Intervention

Ensure Surgical

Study Arms / Comparison Groups

 Intervention
Description:  Subjects randomized to this arm will receive: An Oral Nutritional Supplementation (Ensure Surgical), home-based resistance training, and dietary counseling

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Dietary Supplement

Estimated Enrollment

8

Start Date

August 28, 2017

Completion Date

August 1, 2018

Primary Completion Date

August 1, 2018

Eligibility Criteria

        Inclusion Criteria:

          1. Age 40-89 at the time of study enrollment.

          2. Undergoing pancreatectomy for either chronic pancreatitis or pancreatic cancer.

          3. Ability and willingness to complete study related documents and activities.

        Exclusion Criteria:

          1. Severe malnutrition that in the judgment of the patient's supervising physician or an
             investigator would not permit surgical intervention without preoperative nutritional
             support (enteral or parenteral).

          2. Subject is receiving (or planned to receive) enteral tube feeding or parenteral
             nutrition at the time of screening or before surgery.

          3. Surgery is planned within 7 days of enrollment (i.e., inadequate time to offer the
             study intervention).

          4. Known allergy to soy or milk, which are included in the oral supplement.

          5. The inability to refrain from using a non-study oral nutritional supplement or fish
             oil supplementation (unless prescribed for treatment of hyperlipidemia).

          6. Pregnancy, incarceration, or inability to provide written informed consent.
      

Gender

All

Ages

40 Years - 89 Years

Accepts Healthy Volunteers

No

Contacts

Philip Hart, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03244683

Organization ID

2017H0170


Responsible Party

Principal Investigator

Study Sponsor

Ohio State University

Collaborators

 Abbott Nutrition

Study Sponsor

Philip Hart, MD, Principal Investigator, The Ohio State University Wexner Medical Center


Verification Date

March 2021