Efficacy and Safety of a Novel Mouthpiece for Esophagogastroduodenoscopy: A Multi-Center, Randomized Study
Yuichiro Ikebuchi,
Kazuya Matsumoto,
Naoki Ueda,
Taro Yamashita,
Hiroki Kurumi,
Takumi Onoyama,
Yohei Takeda,
Akira Yoshida,
Koichiro Kawaguchi,
Kazuo Yashima,
Kazunori Fujiwara,
Ryu Imamoto,
Hisashi Noma,
Masaru Ueki,
Hajime Isomoto
Affiliations
Yuichiro Ikebuchi
Division of Medicine and Clinical Science, Department of Multidisciplinary Internal Medicine, Faculty of Medicine, Tottori University, Tottori 683-8504, Japan
Kazuya Matsumoto
Division of Medicine and Clinical Science, Department of Multidisciplinary Internal Medicine, Faculty of Medicine, Tottori University, Tottori 683-8504, Japan
Naoki Ueda
Irisawa Medical Clinic, Shimane 690-0025, Japan
Taro Yamashita
Division of Medicine and Clinical Science, Department of Multidisciplinary Internal Medicine, Faculty of Medicine, Tottori University, Tottori 683-8504, Japan
Hiroki Kurumi
Division of Medicine and Clinical Science, Department of Multidisciplinary Internal Medicine, Faculty of Medicine, Tottori University, Tottori 683-8504, Japan
Takumi Onoyama
Division of Medicine and Clinical Science, Department of Multidisciplinary Internal Medicine, Faculty of Medicine, Tottori University, Tottori 683-8504, Japan
Yohei Takeda
Division of Medicine and Clinical Science, Department of Multidisciplinary Internal Medicine, Faculty of Medicine, Tottori University, Tottori 683-8504, Japan
Akira Yoshida
Division of Medicine and Clinical Science, Department of Multidisciplinary Internal Medicine, Faculty of Medicine, Tottori University, Tottori 683-8504, Japan
Koichiro Kawaguchi
Division of Medicine and Clinical Science, Department of Multidisciplinary Internal Medicine, Faculty of Medicine, Tottori University, Tottori 683-8504, Japan
Kazuo Yashima
Division of Medicine and Clinical Science, Department of Multidisciplinary Internal Medicine, Faculty of Medicine, Tottori University, Tottori 683-8504, Japan
Kazunori Fujiwara
Department of Otolaryngology, Head and Neck Surgery, Division of Medicine of Sensory and Motor Organs, Faculty of Medicine, Tottori University, Tottori 683-8504, Japan
Ryu Imamoto
Department of Gastroenterology, Yasugi Municipal Hospital, Shimane 692-0404, Japan
Hisashi Noma
The Institute of Statistical Mathematics, Tokyo 190-8562, Japan
Masaru Ueki
Advanced Medicine, Innovation and Clinical Research Center, Tottori University Hospital, Tottori 683-8504, Japan
Hajime Isomoto
Department of Gastroenterology, Yasugi Municipal Hospital, Shimane 692-0404, Japan
This randomized trial aimed to compare the safety and efficacy of the GAGLESS mouthpiece for esophagogastroduodenoscopy (EGD) with that of the conventional mouthpiece. In all, 90 participants were divided into the GAGLESS mouthpiece and conventional mouthpiece groups. The primary endpoint was the severity of pain using the visual analog scale (VAS), and secondary endpoints were examination time, past history of endoscopy, success of the procedure, systolic (SBP) and diastolic (DBP) blood pressure, oxygen saturation, pulse rate before and after EGD, and adverse events. Endoscopy was completed in all cases, and no complications were observed. VAS, when passing the scope through the pharynx, was 2.5 ± 2.4 and 2.0 ± 1.9 cm (p = 0.24) in the conventional and GAGLESS groups, respectively, and that, throughout the examination, was 2.5 ± 2.4 and 1.7 ± 1.5 cm (p = 0.06), respectively. The difference in blood pressure between the GAGLESS and conventional groups was not significant for SBP (p = 0.08) and significant for DBP (p = 0.03). The post-EGD difference in DBP was significantly lower in the GAGLESS group than in the conventional group. The results indicate that GAGLESS mouthpieces had a lower VAS during endoscopy than the conventional mouthpieces, and the changes in blood pressure were smaller with the GAGLESS mouthpiece.
