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
  Purpose

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.


Condition Intervention
Patients Following Gastrointestinal Surgery
Dietary Supplement: Resource Support®
Dietary Supplement: Resource Protein®
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Physical Component Summary (from SF 36 Quality of life questionnaire) [ Time Frame: 4 weeks ]

Secondary Outcome Measures:
  • hand grip strength [ Time Frame: 4 weeks ]

Study Start Date: October 2007
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Resource Support® Novartis
Dietary Supplement: Resource Support®
Active Comparator: 2
Resource Protein®, Novartis
Dietary Supplement: Resource Protein®
Placebo Comparator: 3 Dietary Supplement: Placebo

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00546975

Locations
Germany
Dept of Surgery CCM
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Principal Investigator: Herbert Lochs, MD Charite Universitätsmedizin Berlin Dept. of Gastroenterology
  More Information

No publications provided

Responsible Party: Prof Herbert Lochs, Charite University Medicine
ClinicalTrials.gov Identifier: NCT00546975     History of Changes
Other Study ID Numbers: 07.33.CLI
Study First Received: October 18, 2007
Last Updated: June 24, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by Charite University, Berlin, Germany:
gastrointestinal surgery
nutritional intervention
functional status
quality of life

ClinicalTrials.gov processed this record on July 22, 2014