Protein Supplementation
Conditions
Brief summary
Investigators performed a randomized controlled trial of 62 patients undergoing elective abdominal operations. The treatment group was provided a liquid protein supplement and instructed to take a dose three times daily for the first 20 postoperative days. Investigators followed patients for six months and compared wound healing and changes in weight and laboratory values.
Interventions
DIETARY_SUPPLEMENTProstat AWC
Prostat AWC- patients received protein supplementation after surgery
OTHERPlacebo
Placebo- Patients did not take any protein supplementation after surgery
Sponsors
Medical Nutrition USA, Inc.
Eisenhower Army Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* patients scheduled to undergo abdominal surgery \[cholecystectomy, ventral hernia repair, colectomy, non-bariatric gastric surgery, appendectomy, small bowel resection, lysis of adhesions, liver resection, splenectomy, proctectomy, stoma construction, pancreatic surgery, duodenal surgery, adrenal surgery, renal surgery, or cystectomy\]
Exclusion criteria
* Age less than 18 years * Pregnant * Abdominal surgery within the past 6 months * Inability to attend follow-up appointments for at least 6 months * Liver failure (Child-Pugh Class B or C) or kidney failure (glomerular filtration rate (GFR) less than 30).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in weight | Preoperative, and then postoperative at 1-2 weeks, 3 weeks, 1 month, 2 months, 3 months, 6 months | Mean preoperative weight compared to mean postoperative weight at each follow-up appointment. Weight recorded in pounds, subsequent measurements at each postoperative point were normalized to the preoperative weight and reported as a relative percentage of the preoperative weight. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wound healing | Preoperative, and then postoperative at 1-2 weeks, 3 weeks, 1 month, 2 months, 3 months, 6 months | Overall wound healing was documented on a scale of 0-2 (0 for unhealed, 1 for partially healed, 2 for completely healed). A wound was considered partially healed if there was any portion of the wound which had epidermal edges that were not in direct contact. |
| Change in white blood cell count (1x10 3/ uL) | Preoperative, and then postoperative at 1-2 weeks, 3 weeks, 1 month, 2 months, 3 months, 6 months | Change in white blood cell count relative to preoperative white blood cell count, calculated as absolute change |
| Change in total protein (g/ dL) | Preoperative, and then postoperative at 1-2 weeks, 3 weeks, 1 month, 2 months, 3 months, 6 months | Change in total protein at each follow-up point relative to preoperative total protein, calculated as absolute change |
| Change in albumin (g/ dL) | Preoperative, and then postoperative at 1-2 weeks, 3 weeks, 1 month, 2 months, 3 months, 6 months | Change in albumin at each follow-up point relative to preoperative albumin, calculated as absolute change |
| Change in prealbumin (mg/ dL) | Preoperative, and then postoperative at 1-2 weeks, 3 weeks, 1 month, 2 months, 3 months, 6 months | Change in prealbumin at each follow-up point relative to preoperative prealbumin, calculated as absolute change |
Outcome results
None listed