Effect of Oral Nutritional Supplements With Specialized Nutrients on Functional Recovery and Morbidity After Gastrointestinal Surgery
|ClinicalTrials.gov Identifier: NCT00546975|
Recruitment Status : Terminated (Compliance unacceptably low.)
First Posted : October 19, 2007
Last Update Posted : June 27, 2011
Nutritional supplementation in postoperative recovery is still debated. Functional impairment is known to develop both secondary to inflammatory processes or secondary to reduced nutritional intake (e.g. disease induced anorexia). Since major surgery represents a traumatic event, surgical patients are at increased risk of malnutrition due to starvation, activation of neuroendocrine stress axis, inflammation and the subsequent increase in metabolic rate. Gastrointestinal surgery in particular can create additional problems as it often directly affects and limits dietary intake postoperatively and these effects frequently continue after discharge. Whereas manifest malnutrition occurs in about 15% of general surgical patients and in about 40% of oncology patients, postoperative weight loss of 5 to 9% occur in all surgical patients during the first two months. Moreover studies have shown that the nutritional status generally declines in hospital and both functional and nutritional status deteriorate for two months after discharge in malnourished surgical patients.
Most studies that have investigated nutritional support in the surgical setting have concentrated on perioperative or short term postoperative supplementation and focussed on in-hospital infection and complication rate.
Nutritional intake is decreased after surgery which results in an impaired nutritional status which in turn is associated with a decreased functional status. Protein rich nutritional supplementation is able to reverse nutritional depletion and restore functionality.
Surgical stress leads to inflammation; inflammation - in addition to reduced nutritional intake - impairs functional status and increases morbidity. Anti-inflammatory, protein rich nutritional supplementation aims to prevent inflammatory complications and therefore improves functional status and reduces morbidity. In patients with high risk for inflammation, a higher effect of anti-inflammatory oral nutrition on recovery of functional status is expected.
This study aims to determine whether 4 week oral nutritional supplementation and/ or specialized nutrients is effective in restoring functional status and reducing morbidity in surgical patients.
|Condition or disease||Intervention/treatment||Phase|
|Patients Following Gastrointestinal Surgery||Dietary Supplement: Resource Support® Dietary Supplement: Resource Protein® Dietary Supplement: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Study Start Date :||October 2007|
|Actual Primary Completion Date :||September 2009|
|Actual Study Completion Date :||September 2009|
Resource Support® Novartis
|Dietary Supplement: Resource Support®|
Active Comparator: 2
Resource Protein®, Novartis
|Dietary Supplement: Resource Protein®|
|Placebo Comparator: 3||Dietary Supplement: Placebo|
- Physical Component Summary (from SF 36 Quality of life questionnaire) [ Time Frame: 4 weeks ]
- hand grip strength [ Time Frame: 4 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00546975
|Dept of Surgery CCM|
|Berlin, Germany, 10117|
|Principal Investigator:||Herbert Lochs, MD||Charite Universitätsmedizin Berlin Dept. of Gastroenterology|