Clinical outcome of peri-operative enteral immunonutrition for oesophago-gastric cancer
Completed
- Conditions
- Oesophago-gastric cancerCancer
- Registration Number
- ISRCTN43730758
- Lead Sponsor
- The Northern Oesophago-Gastric Cancer Unit (NOGCU) (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 219
Inclusion Criteria
All patients (either sex) presenting to two tertiary centres, between April 2003 to January 2007, with histologically proven oesophageal or gastric malignancy and who were suitable for subtotal oesophagectomy or total gastrectomy with curative intent were eligible for the study.
Exclusion Criteria
1. Less than seven days time from recruitment to operation date
2. Metastatic or unresectable disease
3. Respiratory tract dysfunction (partial pressure of oxygen in arterial blood [PaO2] less than 70 mmHg)
4. Cardiac dysfunction (New York Heart Class greater than three)
5. Hepatic dysfunction (Child-Pugh score greater than B)
6. Concurrent infection
7. Pregnancy
8. Aged less than 18 years
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Development of infective complications. Infective and non-infective complications were noted and graded daily up until discharge. Complications were defined as those published previously (Bozzetti, Braga et al. 2001). This was collected consistently by two full time research registrars designated to the trial.
- Secondary Outcome Measures
Name Time Method on-infective complications, mortality, duration of hospital stay and nutritional status:<br>1. Jejunostomy/feeding-related complications: recorded daily till discharge<br>2. Antibiotic usage: the duration of both prophylactic and therapeutic antibiotic usage was noted<br>3. Length of hospital and critical care stay<br>4. Mortality: both in hospital and 30 days post-operatively was recorded<br>5. Concentration of fatty acids in plasma<br>6. Nutritional status: recorded by two dieticians such as weight, BMI, triceps skin fold thickness and mid-arm muscle circumference