GI Surgery Pre-Operative Nutrition
|ClinicalTrials.gov Identifier: NCT01471743|
Recruitment Status : Completed
First Posted : November 16, 2011
Last Update Posted : February 23, 2016
Surgical patients are high risk for post operative infections. These post operative infections contribute to increased length of hospital stay, hospital costs and delay overall recovery time thus decreasing the quality of life. Studies have reported post operative complications ranging from 37% to 74%.1 The most costly complications include infectious complications after major Gastrointestinal (GI) surgery including wound infections, abdominal abscess, pneumonia, sepsis and anastomic leaks.2 Several studies have been conducted that show a significant reduction in infectious complications and average length of stay when treated with immunonutrition supplements.2-3 A review of similarly designed studies in a different patient population indicate that post-operative infections can be reduced by an average of 71% with immunonutrition.
This study seeks to investigate the effect of Impact Advanced Recovery ® in improving surgical outcomes in patients receiving major gastrointestinal surgeries compared to a standard supplement at James A. Haley Veterans' Hospital. Providing Impact Advanced Recovery ® may decrease post-operative infectious complications, length of stay, and recovery time.
In patients receiving elective gastrointestinal surgery (esophageal, gastric, pancreatic or colon resections) there will be a significant decrease of at least 60% in post-operative infections as listed below for patients who consume 15 servings of Impact Advanced Recovery® pre-operatively compared to patients who consume 15 servings of a standard supplement.
Complications to be considered: anastomatic leak, post-op wound development, post-op abdominal abscess, sepsis, pneumonia, post-op ileus, intestinal fistula, obstruction, urinary tract infections, peritonitis or bowel necrosis.
- In patients receiving elective gastrointestinal surgery (esophageal, gastric, pancreatic or colon resections) there will be a significant decrease in hospital and NPO days for patients who consume 15 servings of Impact Advanced Recovery ® pre-operatively.
|Condition or disease||Intervention/treatment||Phase|
|Immunonutrition||Dietary Supplement: Impact Advance Recovery (R) Dietary Supplement: Ensure Plus (R)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||108 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||The Effect of Pre-Operative Immunonutrition With "Impact Advanced Recovery (R)" on Patients Undergoing Major GI Cancer Surgery|
|Study Start Date :||November 2011|
|Actual Primary Completion Date :||February 2016|
|Actual Study Completion Date :||February 2016|
Experimental: Impact Advance Recovery (R)
3 supplements per day for 5 days pre-operatively
|Dietary Supplement: Impact Advance Recovery (R)|
Active Comparator: Standard Supplement
3 supplement per day for 5 days pre-operatively
|Dietary Supplement: Ensure Plus (R)|
- Number of participants with post-op Infections [ Time Frame: within 30 days post-operatively ]Determine the effectiveness of pre-operative supplementation with Impact Advanced Recovery ® on reducing the risk of developing complications during the 30 day post-operative period with decreased length of hospital stay, and time to resume an oral diet.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01471743
|United States, Florida|
|James A. Haley VA Hospital|
|Tampa, Florida, United States, 33612|