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Randomized Controlled Trial
Double-blind randomized clinical trial of percutaneous endoscopic gastrostomy versus radiologically inserted gastrostomy in children.
- R R Singh, S A Nah, D J Roebuck, S Eaton, A Pierro, J I Curry, and PEG-RIG trial collaborators.
- Department of Paediatric Surgery, UCL Great Ormond Street Institute of Child Health and Great Ormond Street Hospital for Children, London, UK.
- Br J Surg. 2017 Nov 1; 104 (12): 1620-1627.
BackgroundThe aim of this RCT was to determine whether radiologically inserted gastrostomy (RIG) in children is associated with more complications than percutaneous endoscopic gastrostomy (PEG).MethodsChildren at a single tertiary children's hospital requiring a primary gastrostomy were randomized to PEG or RIG. Patients were followed by assessors blinded to the insertion method. Complications were recorded, assigned a severity score, and analysed by zero-inflated Poisson regression analysis on an intention-to-treat basis, adjusting for length of follow-up.ResultsOver a 3-year period, 214 children were randomized (PEG, 107; RIG, 107), of whom 100 received PEG and 96 RIG. There was no significant difference in the number of complications between PEG and RIG groups (P = 0·875), or in the complication score: patients undergoing RIG had a 1·04 (95 per cent c.i. 0·89 to 1·21) times higher complication score than those who underwent PEG (P = 0·597). Only age had an independent significant effect on complication score, with older patients having a 0·97 (0·95 to 1·00) times lower complication score per year.ConclusionPEG and RIG are both safe methods of gastrostomy insertion with a low rate of major complications. Registration number: NCT01920438 ( http://www.clinicaltrials.gov).© 2017 BJS Society Ltd Published by John Wiley & Sons Ltd.
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