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Completed

NCT Number: NCT03073811

Nutritional Perihabilitation in Older Veterans Undergoing Surgery

This research study will be conducted in two parts. The first part will consist of selecting appropriate screening and assessment tools for Veterans undergoing elective surgery and identifying the number of Veterans who are malnourished and at risk of malnutrition. The second portion of the study will be to determine if a protein-enhanced diet before and after surgery will improve function and postoperative outcomes and compare the results to an education control group.

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Key information

Conditions

Malnutrition Abdominal Surgery Nutrition Disorders Nutritional Risk Nutritional and Metabolic Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705, United States

About this study

In year 1 of the two-part research study, an observational, prospective study of 75 Veterans preparing for elective surgery will be conducted. The purpose of this study will be to select appropriate nutrition screening and assessment tools and to employ them to characterize malnutrition prevalence and severity and establish cut-off values associated with malnutrition in this population. In years 2-5 of the research two-part research study, a pilot randomized controlled trial will be conducted. The purpose of this study will be evaluate the feasibility, fidelity, and acceptability of a perioperative protein-enhanced intervention compared to an educational control. Veterans who are malnourished or at risk of being malnourished will be randomly assigned on a 1:1 ratio to either an education (nutritional counseling) control or high-protein perihabilitation arm. Participants in the high-protein perihabilitation arm will be provided with 30 grams of high quality protein supplements three times per day. The study will take place two weeks prior to an elective abdominal or GI surgery and will continue 4 weeks post surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Elective abdominal surgery
  • upper GI
  • colorectal
  • hepatobiliary
  • pancreatic
  • intra-abdominal
  • Abdominal aortic aneurysm
  • Referred to the VA Perioperative Optimization of Senior Health Clinic
  • Able to record dietary intake or has a proxy who can record dietary intake

Exclusion criteria

  • Cognitive impairment
  • Unwillingness to be randomized to either intervention arm, submit to study testing, or continuously participate in the intervention for six weeks
  • Living in skilled nursing facility
  • No access to telephone

Treatment and study plan

Protein enhanced nutrition intervention

Dietary Supplement

Participants will be provided 30 grams of high quality protein (Ensure Max) three times a day for two weeks before surgery and four weeks after surgery.

Other names: Perihabilitation

Education Control

Other

provided educational on the role of nutrition to prepare for and heal from surgery, and Registered Dietitian will instruct participant to follow instruction on handout and one oral nutrition supplement per day for two week before surgery.

Other names: PoshControl

Primary outcomes

  1. Evaluate the Feasibility of a Perioperative Protein-enhanced Intervention Compared to Control Arm.

    Time frame: day of surgery (an average of 12 days from baseline [midpoint]) and 30-day post-surgery (endpoint)

    Feasibility was measured as retention. Hypothesis was that 80% of the participants would be retained.

  2. Determine Acceptability of Perioperative Protein-enhanced Intervention Compared to an Educational Control

    Time frame: 30-day post-surgery follow-up (endpoint)

    Satisfaction of overall participation in the research study (Likert Scale). I am glad I participated in this research study. 1 - Strongly Disagree and 5- Strongly Agree

  3. Physical Function

    Time frame: Baseline, day of surgery (an average of 12 days from baseline), 30-days post-surgery

    Short physical performance battery - higher scores means a better physical performance (Total score = 0-12)

Secondary outcomes

  1. Hospital Readmission

    Time frame: endpoint (30 days post-surgery)

    determine from medical records

  2. Dietary Intake

    Time frame: baseline, day of surgery (midpoint), 30-day post-surgery (endpoint)

    Three day food records will be collected.

  3. Handgrip Strength

    Time frame: baseline, day of surgery (midpoint), 30-day post-surgery (endpoint)

    Hand dynamometer will be used to determine grip strength. Maximum grip strength will be determined by conducting two trials on the dominant hand, with 30 second rest between trials.

  4. Nutritional Risk Screener-2002

    Time frame: baseline, day of surgery (midpoint), 30-day post-surgery (endpoint)

    Validated Nutritional Risk Screener-2002 Questionnaire to determine nutritional risk

  5. Patient Generated-Subjective Global Assessment

    Time frame: baseline, day of surgery (midpoint), 30-day post-surgery (endpoint)

    Validated Patient Generate Subjective Global Assessment Questionnaire to determine malnutrition status

  6. Discharge Location

    Time frame: endpoint (30 days post-surgery)

    determine from medical records

  7. Length of Stay

    Time frame: endpoint (30 days post-surgery)

    determine from medical records

  8. Emergency Department Readmission

    Time frame: endpoint (30 days post-surgery)

    Prevalence of emergency department admissions following surgery.

  9. Postoperative Complications

    Time frame: endpoint (30 days post-surgery)

    determine from medical records

  10. Albumin, g/dL

    Time frame: baseline, day of surgery (midpoint), 30-day post-surgery (endpoint)

    A measure of protein in the blood. Lower level may indicate infection or inflammation.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

Nutritional (High Protein) Perihabilitation in Older Veterans Undergoing Surgery

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Mar 8, 2017
Registry last updated
Apr 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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