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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00546975 |
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Date of registration:
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18/10/2007 |
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Primary sponsor: |
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Public title:
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Effect of Oral Nutritional Supplements With Specialized Nutrients on Functional Recovery and Morbidity After Gastrointestinal Surgery
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Scientific title:
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Date of first enrolment:
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October 2007 |
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Target sample size:
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00546975 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
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Countries of recruitment
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Germany
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Contacts
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Name:
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Herbert Lochs, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Charite Universitätsmedizin Berlin Dept. of Gastroenterology |
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Key inclusion & exclusion criteria
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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
Age minimum:
50 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Patients Following Gastrointestinal Surgery
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Intervention(s)
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Dietary Supplement: Placebo
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Dietary Supplement: Resource Protein®
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Dietary Supplement: Resource Support®
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Primary Outcome(s)
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Physical Component Summary (from SF 36 Quality of life questionnaire)
[Time Frame: 4 weeks]
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Secondary Outcome(s)
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hand grip strength
[Time Frame: 4 weeks]
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Secondary ID(s)
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07.33.CLI
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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