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| ID | Type | Description | Link |
|---|---|---|---|
| 10/H0106/80 | Other Identifier | National Research Ethics Service |
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Failed to recruit full number of patients
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Jejunal feeding | Active Comparator | Nutritional supplementation via their jejunostomies for six weeks post hospital discharge, with continued assessment for a further 18 weeks. |
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| No jejunal feeding | No Intervention | No jejunal feeding of patients for six weeks following hospital discharge, with continued assessment for a further 18 weeks |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Jejunal feeding | Dietary Supplement | A feeding jejunostomy tube is inserted at the time of surgery to provide enteral nutritional support. |
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| Measure | Description | Time Frame |
|---|---|---|
| Fatigue | The primary outcome will therefore be fatigue as measured by the multidimensional fatigue inventory (MFI-20) score. The MFI-20 is divided into five scales: general fatigue, physical fatigue, reduced activity, reduced motivation and mental fatigue. | 18 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | We will use the oesophagus specific quality of life (QLQ-OES18) scale. The QLQ-OES18 scale is a disease specific Health-related quality of life (HRQL) questionnaire, designed to examine the influence of upper gastrointestinal pathology on patients and improvement in HRQL following treatment. | 18 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen J Lewis, MBBS, MD | University Hospital Plymouth NHS Trust | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Plymouth Hospitals NHS Trust | Plymouth | Devon | PL6 8DH | United Kingdom |
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| Health economic analysis |
Health economic analysis will be based on the EuroQol (EQ 5D) scale 4 (this scale defines health in terms of five dimensions: mobility, self care, usual activities, pain and anxiety). |
| 18 weeks |