Abdominal Surgery, Malnutrition, Nutritional Risk
Conditions
Keywords
protein supplementation, older adults, nutrition perihabilitation, perioperative optimization, Veterans
Brief 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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTProtein enhanced nutrition intervention
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.
OTHEREducation Control
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.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the Feasibility of a Perioperative Protein-enhanced Intervention Compared to Control Arm. | 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. |
| Determine Acceptability of Perioperative Protein-enhanced Intervention Compared to an Educational Control | 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 |
| Physical Function | 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
| Measure | Time frame | Description |
|---|---|---|
| Nutritional Risk Screener-2002 | baseline, day of surgery (midpoint), 30-day post-surgery (endpoint) | Validated Nutritional Risk Screener-2002 Questionnaire to determine nutritional risk |
| Patient Generated-Subjective Global Assessment | baseline, day of surgery (midpoint), 30-day post-surgery (endpoint) | Validated Patient Generate Subjective Global Assessment Questionnaire to determine malnutrition status |
| Discharge Location | endpoint (30 days post-surgery) | determine from medical records |
| Hospital Readmission | endpoint (30 days post-surgery) | determine from medical records |
| Emergency Department Readmission | endpoint (30 days post-surgery) | Prevalence of emergency department admissions following surgery. |
| Postoperative Complications | endpoint (30 days post-surgery) | determine from medical records |
| Albumin, g/dL | baseline, day of surgery (midpoint), 30-day post-surgery (endpoint) | A measure of protein in the blood. Lower level may indicate infection or inflammation. |
| Length of Stay | endpoint (30 days post-surgery) | determine from medical records |
| Dietary Intake | baseline, day of surgery (midpoint), 30-day post-surgery (endpoint) | Three day food records will be collected. |
| Handgrip Strength | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PeriHab Provided nutrition counseling and prescribed to consume 1.6 g/kg/body weight as well as provided 30 grams of high quality protein three times per day for two weeks before and four weeks after surgery.
Protein enhanced nutrition intervention: 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. | 26 |
| PoshControl Provided nutrition counseling and prescribed to consume 1.0 g/kg/body weight in the form of educational handouts explained by a Registered Dietitian and one oral nutrition supplement per day for two weeks before surgery.
Education Control: 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. | 24 |
| Total | 50 |
Baseline characteristics
| Characteristic | PeriHab | PoshControl | Total |
|---|---|---|---|
| Age, Continuous | 73.8 years STANDARD_DEVIATION 6.6 | 73.9 years STANDARD_DEVIATION 5.9 | 73.9 years STANDARD_DEVIATION 6.2 |
| Body Mass Index, kg/m^2 | 26.4 kg/m2 STANDARD_DEVIATION 4.1 | 28.5 kg/m2 STANDARD_DEVIATION 6.6 | 27.4 kg/m2 STANDARD_DEVIATION 5.5 |
| Body weight, lbs | 177.4 lbs STANDARD_DEVIATION 32.9 | 195.1 lbs STANDARD_DEVIATION 48.6 | 189.9 lbs STANDARD_DEVIATION 41.7 |
| Cancer Diagnosis | 16 Participants | 15 Participants | 31 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants | 5 Participants | 19 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 12 Participants | 19 Participants | 31 Participants |
| Region of Enrollment United States | 26 Participants | 24 Participants | 50 Participants |
| Sex: Female, Male Female | 2 Participants | 0 Participants | 2 Participants |
| Sex: Female, Male Male | 24 Participants | 24 Participants | 48 Participants |
| Short Physical Performance Battery | 8.2 units on a scale STANDARD_DEVIATION 2.6 | 7.9 units on a scale STANDARD_DEVIATION 2.4 | 8.1 units on a scale STANDARD_DEVIATION 2.5 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 26 | 1 / 24 |
| other Total, other adverse events | 1 / 26 | 0 / 24 |
| serious Total, serious adverse events | 2 / 26 | 1 / 24 |
Outcome results
Primary
Determine Acceptability of Perioperative Protein-enhanced Intervention Compared to an Educational Control
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
Time frame: 30-day post-surgery follow-up (endpoint)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PeriHab | Determine Acceptability of Perioperative Protein-enhanced Intervention Compared to an Educational Control | 4.6 units on a scale | Standard Deviation 0.6 |
| PoshControl | Determine Acceptability of Perioperative Protein-enhanced Intervention Compared to an Educational Control | 4.9 units on a scale | Standard Deviation 0.3 |
Primary
Evaluate the Feasibility of a Perioperative Protein-enhanced Intervention Compared to Control Arm.
Feasibility was measured as retention. Hypothesis was that 80% of the participants would be retained.
Time frame: day of surgery (an average of 12 days from baseline [midpoint]) and 30-day post-surgery (endpoint)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PeriHab | Evaluate the Feasibility of a Perioperative Protein-enhanced Intervention Compared to Control Arm. | Day of Surgery | 23 Participants |
| PeriHab | Evaluate the Feasibility of a Perioperative Protein-enhanced Intervention Compared to Control Arm. | Postoperative Follow-up | 19 Participants |
| PoshControl | Evaluate the Feasibility of a Perioperative Protein-enhanced Intervention Compared to Control Arm. | Day of Surgery | 20 Participants |
| PoshControl | Evaluate the Feasibility of a Perioperative Protein-enhanced Intervention Compared to Control Arm. | Postoperative Follow-up | 16 Participants |
Primary
Physical Function
Short physical performance battery - higher scores means a better physical performance (Total score = 0-12)
Time frame: Baseline, day of surgery (an average of 12 days from baseline), 30-days post-surgery
Population: Perihab (midpoint; n=23) - surgery was cancelled (n=3) PoshControl (midpoint; n=18) - surgery was cancelled (n=3), dropped (n=1); surgery time changed (n=2) Perihab (endpoint; n=18) - surgery was cancelled morning of surgery (n=2); death (n=1); COVID (n=2) PoshControl (n=16; endpoint) - surgery was cancelled morning of surgery (n=2); death (n=1); hospitalization (n=1)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PeriHab | Physical Function | Baseline | 8.2 score on a scale | Standard Deviation 2.6 |
| PeriHab | Physical Function | Morning of Surgery (midpoint) | 9.7 score on a scale | Standard Deviation 2.3 |
| PeriHab | Physical Function | 30 day postop (endpoint) | 9.0 score on a scale | Standard Deviation 2.9 |
| PoshControl | Physical Function | Baseline | 7.9 score on a scale | Standard Deviation 2.4 |
| PoshControl | Physical Function | Morning of Surgery (midpoint) | 9.0 score on a scale | Standard Deviation 2 |
| PoshControl | Physical Function | 30 day postop (endpoint) | 8.8 score on a scale | Standard Deviation 2.3 |
Secondary
Albumin, g/dL
A measure of protein in the blood. Lower level may indicate infection or inflammation.
Time frame: baseline, day of surgery (midpoint), 30-day post-surgery (endpoint)
Secondary
Dietary Intake
Three day food records will be collected.
Time frame: baseline, day of surgery (midpoint), 30-day post-surgery (endpoint)
Secondary
Discharge Location
determine from medical records
Time frame: endpoint (30 days post-surgery)
Secondary
Emergency Department Readmission
Prevalence of emergency department admissions following surgery.
Time frame: endpoint (30 days post-surgery)
Secondary
Handgrip Strength
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.
Time frame: baseline, day of surgery (midpoint), 30-day post-surgery (endpoint)
Secondary
Hospital Readmission
determine from medical records
Time frame: endpoint (30 days post-surgery)
Secondary
Length of Stay
determine from medical records
Time frame: endpoint (30 days post-surgery)
Secondary
Nutritional Risk Screener-2002
Validated Nutritional Risk Screener-2002 Questionnaire to determine nutritional risk
Time frame: baseline, day of surgery (midpoint), 30-day post-surgery (endpoint)
Secondary
Patient Generated-Subjective Global Assessment
Validated Patient Generate Subjective Global Assessment Questionnaire to determine malnutrition status
Time frame: baseline, day of surgery (midpoint), 30-day post-surgery (endpoint)
Secondary
Postoperative Complications
determine from medical records
Time frame: endpoint (30 days post-surgery)