N/A
Completed N=50
Nutritional Perihabilitation in Older Veterans Undergoing Surgery
Malnutrition · Nutritional Risk · Abdominal Surgery
Source: ClinicalTrials.gov NCT03073811 ↗
Enrolled (actual)
50
Serious AEs
6.0%
Results posted
Jan 2024
Primary outcomePrimary: Evaluate the Feasibility of a Perioperative Protein-enhanced Intervention Compared to Control Arm. — 23; 20; 19; 16 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Evaluate the Feasibility of a Perioperative Protein-enhanced Intervention Compared to Control Arm. |
23; 20; 19; 16 | — |
| PRIMARY Determine Acceptability of Perioperative Protein-enhanced Intervention Compared to an Educational Control |
4.6; 4.9 | — |
| PRIMARY Physical Function |
8.2; 7.9; 9.7; 9.0; 9.0; 8.8 | — |
| SECONDARY Hospital Readmission |
— | — |
| SECONDARY Dietary Intake |
— | — |
| SECONDARY Handgrip Strength |
— | — |
| SECONDARY Nutritional Risk Screener-2002 |
— | — |
| SECONDARY Patient Generated-Subjective Global Assessment |
— | — |
| SECONDARY Discharge Location |
— | — |
| SECONDARY Length of Stay |
— | — |
| SECONDARY Emergency Department Readmission |
— | — |
| SECONDARY Postoperative Complications |
— | — |
| SECONDARY Albumin, g/dL |
— | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03073811). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.