Home Jejunostomy Feeding Following Esophagectomy/Gastrectomy
- Conditions
- Esophageal Neoplasms
- Interventions
- Dietary Supplement: Home jejunostomy feeding
- Registration Number
- NCT01870817
- Lead Sponsor
- University Hospitals, Leicester
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 54
- planned esophagectomy or total gastrectomy for adenocarcinoma or squamous carcinoma
- suitable for home enteral nutrition
- inability to provide written informed consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Home jejunostomy feeding Home jejunostomy feeding Six weeks of post hospital discharge home enteral feeding
- Primary Outcome Measures
Name Time Method Participant recruitment and retention rates 7 months This pilot study will inform the design and planning of a larger multi-centre study
- Secondary Outcome Measures
Name Time Method 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
Readmission rates 7 months Readmission rate to hospital during the study period
Nutritional parameters Recruitment, 3 wks, 6 wks, 3 months, 6 months after surgery Grip strength
Health economics 7 months Estimates of healthcare costs for the duration of the study will be calculated
Food intake Recruitment, 3 wks, 6 wks, 3 months, 6 months after surgery Self-completed 3 day food diaries will be assessed
Trial Locations
- Locations (1)
University Hospitals of Leicester NHS Trust
🇬🇧Leicester, Leicestershire, United Kingdom