Endoscopic gastrostomy replacement tubes: Long-term randomized trial with five silicone commercial models

Summary Trial design No analysis of the long-term performance of percutaneous endoscopic gastrostomy (PEG) replacement tubes was identified. A randomized partially blinded trial was designed hypothesizing that clinically relevant limitations of the tubes would be identified. Methods Patients ( N  = ...

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Published in:Clinical nutrition (Edinburgh, Scotland) Scotland), 2014-04, Vol.33 (2), p.221-225
Main Authors: Villela, Emanuele L, Sakai, Paulo, Almeida, Maira R, Moura, Eduardo G.H, Faintuch, Joel
Format: Article
Language:English
Subjects:
Adolescent
Adult
Aged
Aged, 80 and over
Balloon rupture
Biological and medical sciences
Complications
Cross-Over Studies
Endoscopy - instrumentation
Enteral Nutrition - instrumentation
Feeding. Feeding behavior
Female
Fundamental and applied biological sciences. Psychology
Gastroenterology and Hepatology
Gastrostomy
Humans
Intubation, Gastrointestinal
Kaplan–Meier curves
Longevity
Male
Middle Aged
Percutaneous endoscopic gastrostomy
Replacement tubes
Silicones - chemistry
Vertebrates: anatomy and physiology, studies on body, several organs or systems
Young Adult
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Summary:Summary Trial design No analysis of the long-term performance of percutaneous endoscopic gastrostomy (PEG) replacement tubes was identified. A randomized partially blinded trial was designed hypothesizing that clinically relevant limitations of the tubes would be identified. Methods Patients ( N  = 100, age 58.3 ± 20.7 years, 42.0% males, time with PEG 27.0 ± 22.5 months) were randomized in five parallel intervention groups, each with a tested device (Silmag® , Bard® , Freka® , Kangaroo® and Wilson Cook® ). Eligibility criteria included age 18–90 years, males and females, on home enteral nutrition, and the setting was a large academic hospital. Patients were allocated according to a random numbers list, and independent professionals were responsible for data collection. Primary outcome was tube longevity, calculated by Kaplan–Meier curves and Cox regression analysis. A sample of 18 was calculated based on a 10% effect size and 80% power. Results Twenty patients were randomized in each group and all were analyzed. There was no morbidity and mortality, however tube dysfunction was common with all models. Fastener sliding occurred in 57.0% and balloon rupture in 32.0%, along with other mishaps. Best tube longevity corresponded to the Wilson Cook model (158.0 ± 10.0 days, P  
ISSN:0261-5614
1532-1983
DOI:10.1016/j.clnu.2013.04.015