Disposable versus reusable gastroscopes: a prospective randomized noninferiority trial - 14/07/22

Doi : 10.1016/j.gie.2022.03.024

Xiaoya Luo, Dr Med ¹, Ming Ji, MM ¹, Shutian Zhang, MD ¹, Xin Chen, MD ², Ye Zong, MD ¹, Xi Zhang, MD ¹, Haiyi Hu, MD ¹, Xiaowen Hao, MD ¹, Linlin Shao, MD ¹, Can Sun, MD ¹, Haiyun Shi, MD ¹, Junxiong Wang, MD ¹, Bangmao Wang, MD ², Peng Li, MD ^1,^⁎
¹ Department of Gastroenterology, Beijing Friendship Hospital, Capital Medical University, National Clinical Research Center for Digestive Disease, Beijing Digestive Disease Center, Beijing Key Laboratory for Precancerous Lesion of Digestive Disease, Beijing, China
² Department of Gastroenterology and Hepatology, General Hospital, Tianjin Medical University, Tianjin, China

^∗Reprint requests: Peng Li, MD, Department of Gastroenterology, Beijing Friendship Hospital, Capital Medical University, National Clinical Research Center for Digestive Disease, Beijing Digestive Disease Center, Beijing Key Laboratory for Precancerous Lesion of Digestive Disease, Beijing 100050, China.Department of GastroenterologyBeijing Friendship HospitalCapital Medical UniversityNational Clinical Research Center for Digestive DiseaseBeijing Digestive Disease CenterBeijing Key Laboratory for Precancerous Lesion of Digestive DiseaseBeijing100050China

Abstract

Background and Aims

Disposable gastroscopes have recently been developed to eliminate the risk of infection transmission from contaminated reusable gastroscopes. We compared the performance of disposable and reusable gastroscopes in patients undergoing gastroscopy.

Methods

Patients requiring gastroscopy were randomized to either the disposable or reusable digital gastroscope group. The primary endpoint was the success rate of photographing customary anatomic sites, with a noninferiority margin of –8%. Secondary endpoints were technical performance factors such as gastroscope imaging quality, maneuverability, gastroscopy completion rate, device failure/defect rate, operating time, and safety. Data were analyzed using the Newcombe-Wilson score method and Fisher exact 2-tailed t test.

Results

Of 110 patients, 55 were treated using disposable gastroscopes and 55 using reusable gastroscopes. The success rate for capturing images of customary anatomic sites was 100% in both groups. The average imaging quality score was significantly lower (37.02 ± 3.09 vs 39.47 ± 1.92, P < .001) and the operating time significantly longer (P < .001) in the disposable gastroscope group. No significant differences in maneuverability, gastroscopy completion rate, device failure/defect rate, operating time, or safety were found between the 2 groups.

Conclusions

Given the overall safety profile and similar technical performance, disposable gastroscopes represent an alternative to reusable gastroscopes for routine examination, bedside first aid, and some certain circumstances.

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Abbreviations : CI, COVID-19

Plan

Effectiveness evaluation

Safety evaluation

Discussion

DISCLOSURE: All authors disclosed no financial relationships.

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Vol 96 - N° 2

P. 250-261 - août 2022 Retour au numéro

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Disposable versus reusable gastroscopes: a prospective randomized noninferiority trial - 14/07/22

Abstract

Background and Aims

Methods

Results

Conclusions

Plan

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