Nutritional Supplementation Via a Jejunostomy Post Discharge From Hospital Clinical Trial
Official title:
Randomised Trial of Enteral Feeding in Patients Discharged From Hospital Following Surgical Resection of an Upper Gastrointestinal Malignancy
Patients due to undergo surgery for oesophageal and gastric malignancy are often
malnourished. Up to 10% of patients preoperative weight may also be lost during the early
postoperative period. Following discharge from hospital the mechanics of the surgery leads
to a loss of gastric reservoir function, lack of appetite, altered intestinal motility and
gastro-oesophageal reflux which usually results in reduced dietary intake and further weight
loss. In patients who have undergone upper gastrointestinal resections there are no studies
examining the benefit of nutritional supplementation following hospital discharge, however,
studies in other groups of surgical patients have failed to show benefit. Despite patients
who have undergone upper gastrointestinal surgery being 'at risk' nutritionally, there is no
evidence demonstrating the value or not of nutritional supplementation following hospital
discharge.
Hypothesis: The postoperative under nutrition seen after upper gastrointestinal surgery will
exacerbate the reduced quality of life and fatigue patients' already experience. The
investigators hypothesise that improving patient's nutritional intake following hospital
discharge will improve their quality of life and fatigue levels.
For patients undergoing upper gastrointestinal (GI) surgery for cancer:
1. Because of the nature of upper gastrointestinal surgery these patients have been shown
to suffer undernutrition and weight loss after hospital discharge (up to 3 months) and
to a greater extent than other groups of surgical patients. Quality of life and fatigue
is a major issue after upper GI surgery.
2. Nutritional supplementation via a jejunostomy after hospital discharge is only done
routinely for all patients in 10%, and for selected patients in 20% of United Kingdom
(UK) hospitals.
3. Derriford hospital is very unusual in that 85% of patients are given home jejunal
feeding.
4. In Devon and Cornwall home enteral nutrition is delivered under contract by Fresenius
Kabil (a global health care company).
5. There are no studies of home nutritional supplementation in upper GI surgical patients.
6. Studies of home nutritional supplementation in surgical patients having undergone
colorectal surgery have not shown clinical or Quality of Life (QoL) benefit despite
weight gain.
7. The process of enteral nutrition may be associated with a reduction in quality of life.
8. There is a need for a clinical trial to establish the benefit of home enteral
nutritional supplementation. The results of any such trial may influence the highly
variable nutritional present practice and may influence the surgeons desire to place a
feeding jejunostomy (or not) at surgery which is associated with clinical
complications.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care