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 studyReportar como inadecuado




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Trials

, 16:531

First Online: 21 November 2015Received: 05 June 2015Accepted: 12 November 2015DOI: 10.1186-s13063-015-1053-y

Cite this article as: Bowrey, D.J., Baker, M., Halliday, V. et al. Trials 2015 16: 531. doi:10.1186-s13063-015-1053-y

Abstract

BackgroundPoor 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.

MethodsPatients 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.

ResultsFifty-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.

ConclusionsThis 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.

Trial registrationUK 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

AbbreviationsANCOVAanalysis of covariance

BMIbody mass index

CIconfidence interval

CONTcontrol

EORTCEuropean Organisation for Research and Treatment of Cancer

EQ-5Dquality of life tool used for health economics evaluation

HDUhigh dependency unit

ICUintensive care unit

INTintervention

IWRSinteractive web response system

NHSNational Health Service

OG25oesophago-gastric disease specific quality of life instrument

OLSordinary least squares

QALYquality-adjusted life years

QLQ-C30generic EORTC quality of life instrument

QOLquality of life

TTOtime trade-off

UICCUnion for International Cancer Control

UKUnited Kingdom

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Autor: David J. Bowrey - Melanie Baker - Vanessa Halliday - Anne L. Thomas - Ruth Pulikottil-Jacob - Karen Smith - Tom Morris -

Fuente: https://link.springer.com/



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