Patients Following Gastrointestinal Surgery Clinical Trial
| Verified date | October 2007 |
| Source | Charite University, Berlin, Germany |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Germany: Ethics Commission |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 0 |
| Est. completion date | September 2009 |
| Est. primary completion date | September 2009 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 50 Years to 80 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
| Country | Name | City | State |
|---|---|---|---|
| Germany | Dept of Surgery CCM | Berlin |
| Lead Sponsor | Collaborator |
|---|---|
| Charite University, Berlin, Germany |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Physical Component Summary (from SF 36 Quality of life questionnaire) | 4 weeks | ||
| Secondary | hand grip strength | 4 weeks |