Esophageal Neoplasms
Conditions
Keywords
Randomized, Jejunostomy, Enteral, Nutrition, Esophagectomy, Gastrectomy
Brief summary
After surgery for oesophageal (gullet) or gastric (stomach) cancer, patients are routinely fed by means of a small feeding tube into the intestine (jejunostomy, JEJ) while they are in hospital. Current practice is to stop feeding once the patient leaves hospital, although the tube is left in place for the first 6 weeks. Most patients lose weight after surgery and have to learn to adjust to new eating habits and behaviours. A few patients have the JEJ feed restarted because of nutritional problems and this requires a further inpatient stay. It is unknown whether every patient would benefit from this type of feeding at home. Previous studies have only assessed the value of JEJ feeding while patients are still in hospital. There is little known about the benefit of continuing JEJ feeding after discharge from hospital, although home feeding is not uncommon in other patient groups (eg. after a stroke). The proposed study will provide initial information on patients' well being by measuring quality of life and factors such as change in body weight and dietary intake following a period of home JEJ feeding after surgery. Subjects recruited into the study will be placed, randomly, into a control group who receive current nutritional care (based on dietary advice and oral nutritional supplement drinks) or an intervention group who will receive home JEJ feeding for 6 weeks after hospital discharge, in addition to current treatment. If subjects in the control group are experiencing problems eating at home, home feeding through the JEJ tube will be started as needed. The study will also examine how surgery and JEJ feeding at home impact on the patient and carer(s) by means of questionnaires and interviews conducted in the patients' home. Information obtained will assist in the design of a multicentre study. This intervention is considered important because it has the potential to benefit thousands of patients each year at a modest cost.
Interventions
DIETARY_SUPPLEMENTHome jejunostomy feeding
Sponsors
University of Leicester
University of Sheffield
University of Warwick
University Hospitals, Leicester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* planned esophagectomy or total gastrectomy for adenocarcinoma or squamous carcinoma * suitable for home enteral nutrition
Exclusion criteria
* inability to provide written informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant recruitment and retention rates | 7 months | This pilot study will inform the design and planning of a larger multi-centre study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nutritional parameters | Recruitment, 3 wks, 6 wks, 3 months, 6 months after surgery | Absolute body weight |
| Health economics | 7 months | Estimates of healthcare costs for the duration of the study will be calculated |
| Quality of life | Recruitment, 3 wks, 6 wks, 3 months, 6 months after surgery | Variability in disease specific and generic quality of life measures will be assessed |
| Qualitative analysis | 8 weeks | Interviews will be conducted with up to 10 participants and their carers & thematic qualitative analysis of interviews performed |
| Food intake | Recruitment, 3 wks, 6 wks, 3 months, 6 months after surgery | Self-completed 3 day food diaries will be assessed |
| Readmission rates | 7 months | Readmission rate to hospital during the study period |
Countries
United Kingdom
Outcome results
None listed