Safety and efficacy of a novel disposable sheathed gastroscopic system in clinical practice.
J Gastroenterol Hepatol
; 29(4): 757-61, 2014 Apr.
Article
em En
| MEDLINE
| ID: mdl-24325649
ABSTRACT
BACKGROUND AND AIM:
Endoscopic examinations carry a potential risk of cross-infection, and the traditional reprocessing method is time consuming. We evaluated the safety and efficacy of a novel disposable sheathed gastroscope system in clinical practice in comparison with the conventional gastroscope.METHODS:
There were two phases in the study. In phase 1, 20 patients with hepatitis B were randomized into two groups the sheathed group was examined with the novel disposable sheathed gastroscope (n = 10) and the conventional group with the conventional gastroscope (n = 10). Microbiologic tests were performed on each endoscope afterwards. In the second phase, 1120 patients were randomized again into the same two groups with 568 and 552 patients in the sheathed group and the conventional group, respectively. The time duration of the endoscopic procedure and reprocessing were measured. The pathology detection rate of endoscopic examinations, the patients' subjective feelings, and problems occurred during procedures were also recorded.RESULTS:
The total instrument turn-around time in the phase 2 sheathed group (9.9 ± 1.3 min) was significantly shorter than the conventional group (39.0 ± 1.4 min, P = 0.000). The mean procedural time was slightly longer in the sheathed group than in the conventional group (4.9 ± 1.4 vs 4.1 ± 1.3 min, P = 0.000). However, the duration of endoscopic reprocessing was much shorter (4.9 ± 0.2 vs 35 ± 0.2 min, P = 0.000). No significant differences were observed in patient discomfort, optical clarity, or pathology detection rate. There were no complications in either group, and no microbial contamination was detected in phase 1 of the study.CONCLUSIONS:
Compared with the conventional gastroscope, the novel disposable sheathed gastroendoscope is safe and more efficient in clinical practice.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Infecção Hospitalar
/
Contaminação de Equipamentos
/
Gastroscópios
/
Equipamentos Descartáveis
/
Segurança de Equipamentos
Tipo de estudo:
Clinical_trials
/
Etiology_studies
/
Risk_factors_studies
Limite:
Adult
/
Humans
/
Male
País/Região como assunto:
Asia
Idioma:
En
Revista:
J Gastroenterol Hepatol
Assunto da revista:
GASTROENTEROLOGIA
Ano de publicação:
2014
Tipo de documento:
Article
País de afiliação:
China