Oral Protein Supplementation Following Non-bariatric Surgery

Study Overview
=================
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.

Official Title
-----------------
A Randomized Trial of Oral Protein Supplementation Following Non-bariatric Abdominal Surgery

Conditions
-----------------
Protein Supplementation

Intervention / Treatment
-----------------
* Dietary Supplement: Prostat AWC
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>The patients in the control group did not receive any supplementation, and were directed to follow the dietary guidelines of their surgeon. | Other: Placebo<br>* Placebo- Patients did not take any protein supplementation after surgery<br>* Other names: No intervention;|
| Experimental: Treatment<br>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. | Dietary Supplement: Prostat AWC<br>* Prostat AWC- patients received protein supplementation after surgery<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in weight | 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. | Preoperative, and then postoperative at 1-2 weeks, 3 weeks, 1 month, 2 months, 3 months, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound healing | 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. | Preoperative, and then postoperative at 1-2 weeks, 3 weeks, 1 month, 2 months, 3 months, 6 months | 
| Change in white blood cell count (1x10 3/ uL) | Change in white blood cell count relative to preoperative white blood cell count, calculated as absolute change | Preoperative, and then postoperative at 1-2 weeks, 3 weeks, 1 month, 2 months, 3 months, 6 months | 
| Change in total protein (g/ dL) | Change in total protein at each follow-up point relative to preoperative total protein, calculated as absolute change | Preoperative, and then postoperative at 1-2 weeks, 3 weeks, 1 month, 2 months, 3 months, 6 months | 
| Change in albumin (g/ dL) | Change in albumin at each follow-up point relative to preoperative albumin, calculated as absolute change | Preoperative, and then postoperative at 1-2 weeks, 3 weeks, 1 month, 2 months, 3 months, 6 months | 
| Change in prealbumin (mg/ dL) | Change in prealbumin at each follow-up point relative to preoperative prealbumin, calculated as absolute change | Preoperative, and then postoperative at 1-2 weeks, 3 weeks, 1 month, 2 months, 3 months, 6 months |