Oral Protein Supplementation Following Non-bariatric Surgery

Protein Supplementation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02622698
• Other study ID #: 356154
• Status: Completed
• Phase: N/A
• First received: December 1, 2015
• Last updated: December 2, 2015
• Start date: August 2011
• Est. completion date: June 2012

Study information

• Verified date: December 2015
• Source: Eisenhower Army Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Protein Supplementation

Intervention

Dietary Supplement:
• Prostat AWC
Prostat AWC- patients received protein supplementation after surgery

Other:
• Placebo
Placebo- Patients did not take any protein supplementation after surgery

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Eisenhower Army Medical Center	Medical Nutrition USA, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No