- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03244683
A Study of the Efficacy of ONS to Reduce Postoperative Complications Associated With Pancreatic Surgery (INSPIRE)
A Study of the Efficacy of Oral Nutritional Supplementation to Reduce Postoperative Complications Associated With Pancreatic Surgery
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.
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43210
- The Ohio State University Wexner Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 40-89 at the time of study enrollment.
- Undergoing pancreatectomy for either chronic pancreatitis or pancreatic cancer.
- Ability and willingness to complete study related documents and activities.
Exclusion Criteria:
- 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).
- Subject is receiving (or planned to receive) enteral tube feeding or parenteral nutrition at the time of screening or before surgery.
- Surgery is planned within 7 days of enrollment (i.e., inadequate time to offer the study intervention).
- Known allergy to soy or milk, which are included in the oral supplement.
- The inability to refrain from using a non-study oral nutritional supplement or fish oil supplementation (unless prescribed for treatment of hyperlipidemia).
- Pregnancy, incarceration, or inability to provide written informed consent.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: Intervention
Subjects randomized to this arm will receive: An Oral Nutritional Supplementation (Ensure Surgical), home-based resistance training, and dietary counseling
|
Subjects randomized to the intervention arm will consume two Ensure Surgical for 5-7 days.
All study subjects will be provided with nutrition counseling at the time of study enrollment.
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.
|
OTHER: Nutrition Counseling alone
Subjects randomized to this arm will receive: Dietary counseling along with standard of care procedures.
|
All study subjects will be provided with nutrition counseling at the time of study enrollment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative complications
Time Frame: 30 days
|
The postoperative complication rate of 1 or more complication
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Supplement compliance
Time Frame: 7-14 days
|
Frequency of subjects compliant with ≥70% of the provided preoperative supplement.
|
7-14 days
|
Anthropometric measures
Time Frame: 30 days
|
Serial anthropometric measures.
|
30 days
|
Length of stay and readmission
Time Frame: 30 days
|
Hospital length of stay and readmission rate
|
30 days
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Philip Hart, MD, The Ohio State University Wexner Medical Center
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017H0170
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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