Effect of Oral Nutritional Supplements With Specialized Nutrients on Functional Recovery and Morbidity After Gastrointestinal Surgery

This study has been terminated.
(Compliance unacceptably low.)
Sponsor:
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00546975
First received: October 18, 2007
Last updated: June 24, 2011
Last verified: October 2007

October 18, 2007
June 24, 2011
October 2007
September 2009   (final data collection date for primary outcome measure)
Physical Component Summary (from SF 36 Quality of life questionnaire) [ Time Frame: 4 weeks ]
• Physical Component Summary (from SF 36 Quality of life questionnaire) [ Time Frame: 4 weeks ]
Complete list of historical versions of study NCT00546975 on ClinicalTrials.gov Archive Site
hand grip strength [ Time Frame: 4 weeks ]
Same as current
Not Provided
Not Provided
 
Effect of Oral Nutritional Supplements With Specialized Nutrients on Functional Recovery and Morbidity After Gastrointestinal Surgery
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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.

Hypothesis I:

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.

Hypothesis II:

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Patients Following Gastrointestinal Surgery
  • Dietary Supplement: Resource Support®
  • Dietary Supplement: Resource Protein®
  • Dietary Supplement: Placebo
  • Experimental: 1
    Resource Support® Novartis
    Intervention: Dietary Supplement: Resource Support®
  • Active Comparator: 2
    Resource Protein®, Novartis
    Intervention: Dietary Supplement: Resource Protein®
  • Placebo Comparator: 3
    Intervention: Dietary Supplement: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
Not Provided
September 2009
September 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patients who are > 50 years of age and < 80 years
  2. Patients who have signed a written Informed Consent (Appendix I) prior to admission to the study.
  3. Patients who have an ECOG performance status (presurgery) of 0, 1 or 2 (Appendix II).
  4. Patients able to orally consume 500 mL or more of liquid a day after adaption
  5. Patients undergoing elective gastrointestinal surgery [e.g. Colorectal surgery: colectomy, hemicolectomy, proctectomy; Small bowel resection/surgery; liver resection, splenectomy, non-whipple pancreatic surgery]

Exclusion Criteria:

  1. Patients who are > 80 years of age and < 50 years
  2. Patients who have co-morbid conditions, uncontrolled metabolic conditions or psychiatric conditions that might make tolerance or evaluation of the feeding formula difficult;
  3. Patients undergoing Whipple´s procedure, gastrectomy, oesophageal resection
  4. Patients who get preoperative nutritional support
  5. Patients taking supplements (EPA, DHA)
  6. Any concomitant severe disease e.g.

    • Patients with respiratory failure (FEV<0.8l/sec)
    • Patients with renal failure (Cr > 3mg/dl or dialysis patients)
    • Patients with hepatic dysfunction (Child >A)
    • Patients with cardiac failure (NYHA > III)
  7. Patients suffering from an intestinal obstruction or ileus
  8. Patients with an Hb level of >8 g/dL experiencing gastrointestinal haemorrhaging
  9. Patients with HIV
  10. Patients requiring immunosuppression treatments
  11. Pregnancy
  12. Patients undergoing emergency surgery
  13. Other patients determined by a study investigator to be inappropriate for enrolment in this study
Both
50 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00546975
07.33.CLI
Yes
Prof Herbert Lochs, Charite University Medicine
Charite University, Berlin, Germany
Not Provided
Principal Investigator: Herbert Lochs, MD Charite Universitätsmedizin Berlin Dept. of Gastroenterology
Charite University, Berlin, Germany
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP