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Completed

NCT Number: NCT02622698

Oral Protein Supplementation Following Non-bariatric 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.

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Key information

Conditions

Protein Supplementation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Prostat AWC

Dietary Supplement

Prostat AWC- patients received protein supplementation after surgery

Placebo

Other

Placebo- Patients did not take any protein supplementation after surgery

Other names: No intervention

Primary outcomes

  1. Change in weight

    Time frame: 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 outcomes

  1. Wound healing

    Time frame: 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.

  2. Change in white blood cell count (1x10 3/ uL)

    Time frame: 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

  3. Change in total protein (g/ dL)

    Time frame: 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

  4. Change in albumin (g/ dL)

    Time frame: 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

  5. Change in prealbumin (mg/ dL)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Eisenhower Army Medical Center

Fed

Collaborators

  • Medical Nutrition USA, Inc.

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Dec 4, 2015
Registry last updated
Dec 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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