Home Jejunostomy Feeding Following Esophagectomy/Gastrectomy
NCT ID: NCT01870817
Last Updated: 2014-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
54 participants
INTERVENTIONAL
2012-07-31
2014-08-31
Brief Summary
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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
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Home jejunostomy feeding
Six weeks of post hospital discharge home enteral feeding
Home jejunostomy feeding
Control
Standard care
No interventions assigned to this group
Interventions
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Home jejunostomy feeding
Eligibility Criteria
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Inclusion Criteria
* suitable for home enteral nutrition
Exclusion Criteria
18 Years
ALL
No
Sponsors
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University of Leicester
OTHER
University of Sheffield
OTHER
University of Warwick
OTHER
University Hospitals, Leicester
OTHER
Responsible Party
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Principal Investigators
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David J Bowrey, MD
Role: STUDY_DIRECTOR
University Hospitals, Leicester
Locations
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University Hospitals of Leicester NHS Trust
Leicester, Leicestershire, United Kingdom
Countries
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References
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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.
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.
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.
Related Links
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Published trial protocol
Other Identifiers
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PB-PG-0610-22480
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
12447
Identifier Type: OTHER
Identifier Source: secondary_id
34769
Identifier Type: -
Identifier Source: org_study_id