Oral Protein Supplementation Following Non-bariatric Surgery
- Conditions
- Protein Supplementation
- Interventions
- Other: PlaceboDietary Supplement: Prostat AWC
- Registration Number
- NCT02622698
- Lead Sponsor
- Eisenhower Army Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 62
- 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]
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Placebo The patients in the control group did not receive any supplementation, and were directed to follow the dietary guidelines of their surgeon. Treatment Prostat AWC Patients were instructed to consume one ounce (containing 16 grams of protein) of the supplement three times daily. No other modifications were made to the patient's diet. Patients were provided with a total of 60 doses, which would last 20 days if they consumed each dose as instructed.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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
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 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
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