Skip to content

Enteral Feeding in Discharged Patients

Randomised Trial of Enteral Feeding in Patients Discharged From Hospital Following Surgical Resection of an Upper Gastrointestinal Malignancy

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02155140
Enrollment
45
Registered
2014-06-04
Start date
2011-02-28
Completion date
2015-01-31
Last updated
2015-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nutritional Supplementation Via a Jejunostomy Post Discharge From Hospital, Surgical Resection of an Upper Gastrointestinal Malignancy

Keywords

enteral feeding, Discharged, surgical resection of an upper gastrointestinal malignancy, Nutritional supplementation via a jejunostomy

Brief summary

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.

Detailed description

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.

Interventions

DIETARY_SUPPLEMENTJejunal feeding

A feeding jejunostomy tube is inserted at the time of surgery to provide enteral nutritional support.

Sponsors

University Hospital Plymouth NHS Trust
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients able to give written informed consent, * Have had a feeding jejunostomy placed at surgery, * Competent (or their carer) to set up and use the jejunostomy feeding apparatus themselves.

Exclusion criteria

* Participating in another interventional trial, * Age \<18, * Pre-operative BMI \> 35, * Pre-operative BMI \<18, * Oral intake at hospital discharge of \> 90% of requirements, * It is felt that they or their carers would not to cope with home tube feeding Patients unable to give written informed consent.

Design outcomes

Primary

MeasureTime frameDescription
Fatigue18 weeksThe 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.

Secondary

MeasureTime frameDescription
Quality of life18 weeksWe 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.
Health economic analysis18 weeksHealth 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).

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026