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| ID | Type | Description | Link |
|---|---|---|---|
| PB-PG-0610-22480 | Other Grant/Funding Number | UK NIHR Research for Patient Benefit | |
| 12447 | Other Identifier | UKCRN |
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| Name | Class |
|---|---|
| University of Leicester | OTHER |
| University of Sheffield | OTHER |
| University of Warwick | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Home jejunostomy feeding | Active Comparator | Six weeks of post hospital discharge home enteral feeding |
|
| Control | No Intervention | Standard care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home jejunostomy feeding | Dietary Supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Participant recruitment and retention rates | This pilot study will inform the design and planning of a larger multi-centre study | 7 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | Variability in disease specific and generic quality of life measures will be assessed | Recruitment, 3 wks, 6 wks, 3 months, 6 months after surgery |
| Nutritional parameters | Absolute body weight |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David J Bowrey, MD | University Hospitals, Leicester | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals of Leicester NHS Trust | Leicester | Leicestershire | LE1 5WW | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28656968 | Derived | Baker ML, Halliday V, Robinson P, Smith K, Bowrey DJ. Nutrient intake and contribution of home enteral nutrition to meeting nutritional requirements after oesophagectomy and total gastrectomy. Eur J Clin Nutr. 2017 Sep;71(9):1121-1128. doi: 10.1038/ejcn.2017.88. Epub 2017 Jun 28. | |
| 26590903 | Derived | Bowrey DJ, Baker M, Halliday V, Thomas AL, Pulikottil-Jacob R, Smith K, Morris T, Ring A. A randomised controlled trial of six weeks of home enteral nutrition versus standard care after oesophagectomy or total gastrectomy for cancer: report on a pilot and feasibility study. Trials. 2015 Nov 21;16:531. doi: 10.1186/s13063-015-1053-y. |
| Label | URL |
|---|---|
| Published trial protocol | View source |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Recruitment, 3 wks, 6 wks, 3 months, 6 months after surgery |
| Health economics | Estimates of healthcare costs for the duration of the study will be calculated | 7 months |
| Readmission rates | Readmission rate to hospital during the study period | 7 months |
| Qualitative analysis | Interviews will be conducted with up to 10 participants and their carers & thematic qualitative analysis of interviews performed | 8 weeks |
| Food intake | Self-completed 3 day food diaries will be assessed | Recruitment, 3 wks, 6 wks, 3 months, 6 months after surgery |
| Nutritional parameters | Body mass index | Recruitment, 3 wks, 6 wks, 3 months, 6 months after surgery |
| Nutritional parameters | Mid arm circumference | Recruitment, 3 wks, 6 wks, 3 months, 6 months after surgery |
| Nutritional parameters | Triceps fold thickness | Recruitment, 3 wks, 6 wks, 3 months, 6 months after surgery |
| Nutritional parameters | Grip strength | Recruitment, 3 wks, 6 wks, 3 months, 6 months after surgery |
| 24885032 | Derived | Bowrey DJ, Baker M, Halliday V, Thomas AL, Pulikottil-Jacob R, Smith K. Six weeks of home enteral nutrition versus standard care after esophagectomy or total gastrectomy for cancer: study protocol for a randomized controlled trial. Trials. 2014 May 24;15:187. doi: 10.1186/1745-6215-15-187. |
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |