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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.

ABSTRACT: Poor nutrition in the first months after oesophago-gastric resection is a contributing factor to the reduced quality of life seen in these patients. The aim of this pilot and feasibility study was to ascertain the feasibility of conducting a multi-centre randomised controlled trial to evaluate routine home enteral nutrition in these patients.Patients undergoing oesophagectomy or total gastrectomy were randomised to either six weeks of home feeding through a jejunostomy (intervention), or treatment as usual (control). Intervention comprised overnight feeding, providing 50 % of energy and protein requirements, in addition to usual oral intake. Primary outcome measures were recruitment and retention rates at six weeks and six months. Nutritional intake, nutritional parameters, quality of life and healthcare costs were also collected. Interviews were conducted with a sample of participants, to ascertain patient and carer experiences.Fifty-four of 112 (48 %) eligible patients participated in the study over the 20 months. Study retention at six weeks was 41/54 patients (76 %) and at six months was 36/54 (67 %). At six weeks, participants in the control group had lost on average 3.9 kg more than participants in the intervention group (95 % confidence interval [CI] 1.6 to 6.2). These differences remained evident at three months (mean difference 2.5 kg, 95 % CI -0.5 to 5.6) and at six months (mean difference 2.5 kg, 95 % CI -1.2 to 6.1). The mean values observed in the intervention group for mid arm circumference, mid arm muscle circumference, triceps skin fold thickness and right hand grip strength were greater than for the control group at all post hospital discharge time points. The economic evaluation suggested that it was feasible to collect resource use and EQ-5D data for a full cost-effectiveness analysis. Thematic analysis of 15 interviews identified three main themes related to the intervention and the trial: 1) a positive experience, 2) the reasons for taking part, and 3) uncertainty of the study process.This study demonstrated that home enteral feeding by jejunostomy was feasible, safe and acceptable to patients and their carers. Whether home enteral feeding as 'usual practice' is a cost-effective therapy would require confirmation in an appropriately powered, multi-centre study.UK Clinical Research Network ID 12447 (main trial, first registered 30 May 2012); UK Clinical Research Network ID 13361 (qualitative substudy, first registered 30 May 2012); ClinicalTrials.gov NCT01870817 (first registered 28 May 2013).

SUBMITTER: Bowrey DJ

PROVIDER: S-EPMC4654827 | biostudies-literature | 2015 Nov

REPOSITORIES: biostudies-literature

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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.

Bowrey David J DJ Baker Melanie M Halliday Vanessa V Thomas Anne L AL Pulikottil-Jacob Ruth R Smith Karen K Morris Tom T Ring Arne A Ring Arne A

Trials 20151121

<h4>Background</h4>Poor nutrition in the first months after oesophago-gastric resection is a contributing factor to the reduced quality of life seen in these patients. The aim of this pilot and feasibility study was to ascertain the feasibility of conducting a multi-centre randomised controlled trial to evaluate routine home enteral nutrition in these patients.<h4>Methods</h4>Patients undergoing oesophagectomy or total gastrectomy were randomised to either six weeks of home feeding through a jej ...[more]

PMID: 26590903

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Project description:Each year approximately 3000 patients in the United Kingdom undergo surgery for esophagogastric cancer. Jejunostomy feeding tubes, placed at the time of surgery for early postoperative nutrition, have been shown to have a positive impact on clinical outcomes in the short term. Whether feeding out of hospital is of benefit is unknown. Local experience has identified that between 15 and 20% of patients required 'rescue' jejunostomy feeding for nutritional problems and weight loss while at home. This weight loss and poor nutrition may contribute to the detrimental effect on the overall quality of life (QoL) reported in these patients.This randomized pilot and feasibility study will provide preliminary information on the routine use of jejunostomy feeding after hospital discharge in terms of clinical benefits and QoL. Sixty participants undergoing esophagectomy or total gastrectomy will be randomized to receive either a planned program of six weeks of home jejunostomy feeding after discharge from hospital (intervention) or treatment-as-usual (control). The intention of this study is to inform a multi-centre randomized controlled trial. The primary outcome measures will be recruitment and retention rates at six weeks and six months. Secondary outcome measures will include disease specific and general QoL measures, nutritional parameters, total and oral nutritional intake, hospital readmission rates, and estimates of healthcare costs. Up to 20 participants will also be enrolled in a qualitative sub-study that will explore participants' and carers' experiences of home tube feeding.The results will be disseminated by presentation at surgical, gastroenterological and dietetic meetings and publication in appropriate peer review journals. A patient-friendly lay summary will be made available on the University of Leicester and the University Hospitals of Leicester NHS Trust websites. The study has full ethical and institutional approval and started recruitment in July 2012.UKClinical Research Network ID #12447 (Main study); UKCRN ID#13361 (Qualitative sub study); ClinicalTrials.gov #NCT01870817 (First registered 28 May 2013).

Project description:BackgroundNot only has the placement rate of enteral feeding tubes during operations for esophageal cancer increased, but also has number of patients who choose to continue enteral feeding at home instead of removing the feeding tube at discharge. The impacts of home enteral nutrition (HEN) after esophagectomy in esophageal cancer patients are analyzed.MethodsA systematic review was conducted in accordance with PRISMA and Cochrane guidelines. English and Chinese databases, including PubMed, Embase, Web of Science, The Cochrane Library, Scopus, CBM, CNKI, and Wan Fang were searched from inception to December 7, 2019. Randomized controlled trials evaluating the short-term outcomes of HEN following esophagectomy in cancer patients were included. The risk of bias of the included studies was appraised according to the Cochrane risk of bias tool. The summary of relative risk/weighted mean difference (WMD) estimates and corresponding 95% confidence interval (95% CI) were calculated using fixed- and random-effects models.ResultsNine randomized controlled trials involving 757 patients were included in the meta-analysis. Compared with oral diet, HEN was associated with significantly increased body weight (WMD 3 kg, 95% CI 2.36-3.63, P < .001), body mass index (WMD 0.97 kg/m, 95% CI 0.74-1.21, P < .001), albumin (WMD 3.43 g/L, 95% CI 2.35-4.52, P < .001), hemoglobin (WMD 7.23 g/L, 95% CI 5.87-8.59, P < .001), and total protein (WMD 5.13 g/L, 95% CI 3.7-6.56, P < .001). No significant differences were observed in prealbumin and gastrointestinal adverse reactions. Physical (WMD 8.82, 95% CI 6.69-10.95, P < .001) and role function (WMD 12.23, 95% CI 2.72-21.74, P = .01) were also significantly better in the HEN group. The nausea/vomiting (WMD -5.43, 95% CI -8.29 to -2.57, P = .002) and fatigue symptoms (WMD -11.76, 95% CI -16.21 to -7.32, P < .001) were significantly reduced. Appetite loss (WMD -8.48, 95% CI -14.27 to -4.88, P = .001), diarrhea (WMD -3.9, 95% CI -7.37 to -0.43, P = .03), and sleep disturbance (WMD -7.64, 95% CI -12.79 to -2.5, P = .004) in the HEN group were also significantly less than the control group.ConclusionsHEN improved nutrition status, physical and role function, and reduced nausea/vomiting, fatigue, appetite loss, diarrhea, and sleep disturbance compared with an oral diet in esophageal cancer patients postsurgery. HEN did not increase adverse reactions.

Dataset Information

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.

Publications

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.

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