Oral Protein Supplementation Following Non-bariatric Surgery

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

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.

Study Overview

• Status: Completed
• Conditions: Protein Supplementation
• Intervention / Treatment: Other: Placebo; Dietary supplement: Prostat AWC

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Eisenhower Army Medical Center
• Collaborators: Medical Nutrition USA, Inc.

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: December 1, 2015
• First Submitted That Met QC Criteria: December 2, 2015
• First Posted (Estimate): December 4, 2015

Study Record Updates

• Last Update Posted (Estimate): December 4, 2015
• Last Update Submitted That Met QC Criteria: December 2, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: 356154