Clinical nutrition (Edinburgh, Scotland) · 2013
Endoscopic gastrostomy replacement tubes: long-term randomized trial with five silicone commercial models.
СтатьяРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
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Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Villela Emanuele L, Sakai Paulo, Almeida Maira R, Moura Eduardo G H, Faintuch Joel
Аннотация
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 < 0.05), mostly on account of diminished balloon ruptures.
CONCLUSIONS: PEG replacement was safe however relatively frequent and affecting longevity, therefore longer-lasting tubes are needed. Specific attention should be given to cap, feeding line, external clamp, tube fastener; tube length, and notably balloon performance, which may be disappointing. Trial NCT01698827, CNPq Investigator Grant 302915/2011-7.
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 < 0.05), mostly on account of diminished balloon ruptures.
CONCLUSIONS: PEG replacement was safe however relatively frequent and affecting longevity, therefore longer-lasting tubes are needed. Specific attention should be given to cap, feeding line, external clamp, tube fastener; tube length, and notably balloon performance, which may be disappointing. Trial NCT01698827, CNPq Investigator Grant 302915/2011-7.