Prasit Mahawongkajit1, Prakitpunthu Tomtitchong2, Nuttorn Boochangkool2, Chatchai Mingmalairak2, Surajit Awsakulsutthi2, Chittinad Havanond2. 1. Department of Surgery, Faculty of Medicine, Thammasat University (Rangsit Campus), 99/209 Moo 18, Paholyothin Road, Amphur Klongluang, Pathumthani, 12120, Thailand. prasit_md@yahoo.com. 2. Department of Surgery, Faculty of Medicine, Thammasat University (Rangsit Campus), 99/209 Moo 18, Paholyothin Road, Amphur Klongluang, Pathumthani, 12120, Thailand.
Abstract
OBJECTIVES:Esophageal stricture is a significant complication of grade 2b and 3a esophageal injuries and causes much patient suffering. Preventing strictures would be beneficial to patients but there are currently no proven effective drugs. This study aimed to evaluate the effect of omeprazole for preventing esophageal stricture in adults with grade 2b and 3a corrosive esophageal injuries. METHODS: This study was an open single-center prospective randomized controlled trial that took place from April 2018 to January 2020. Patients were randomized to standard treatment or 80 mg/day intravenously × 3 days followed by 40 mg/day orally for 4 weeks. They were endoscoped at baseline and 4 weeks post discharge. Strictures were confirmed radiologically. RESULTS:20 patients were enrolled: 15 with grade 2b and five with grade 3a injuries. Standard care and omeprazole groups numbered 10 each. At 1 month, seven and two patients developed strictures in the standard and omeprazole groups, respectively, p = 0.024, for a risk reduction of 71.4%. CONCLUSIONS:Omeprazole reduced the risk of short-term developing esophageal strictures following grade 2b and 3a corrosive esophageal injuries. Larger studies are needed to reconfirm this finding. Thai Clinical Trials Registry (TCTR) number TCTR20190504001.
RCT Entities:
OBJECTIVES: Esophageal stricture is a significant complication of grade 2b and 3a esophageal injuries and causes much patient suffering. Preventing strictures would be beneficial to patients but there are currently no proven effective drugs. This study aimed to evaluate the effect of omeprazole for preventing esophageal stricture in adults with grade 2b and 3a corrosive esophageal injuries. METHODS: This study was an open single-center prospective randomized controlled trial that took place from April 2018 to January 2020. Patients were randomized to standard treatment or 80 mg/day intravenously × 3 days followed by 40 mg/day orally for 4 weeks. They were endoscoped at baseline and 4 weeks post discharge. Strictures were confirmed radiologically. RESULTS: 20 patients were enrolled: 15 with grade 2b and five with grade 3a injuries. Standard care and omeprazole groups numbered 10 each. At 1 month, seven and two patients developed strictures in the standard and omeprazole groups, respectively, p = 0.024, for a risk reduction of 71.4%. CONCLUSIONS:Omeprazole reduced the risk of short-term developing esophageal strictures following grade 2b and 3a corrosive esophageal injuries. Larger studies are needed to reconfirm this finding. Thai Clinical Trials Registry (TCTR) number TCTR20190504001.
Authors: Mircea Chirica; Michael D Kelly; Stefano Siboni; Alberto Aiolfi; Carlo Galdino Riva; Emanuele Asti; Davide Ferrari; Ari Leppäniemi; Richard P G Ten Broek; Pierre Yves Brichon; Yoram Kluger; Gustavo Pereira Fraga; Gil Frey; Nelson Adami Andreollo; Federico Coccolini; Cristina Frattini; Ernest E Moore; Osvaldo Chiara; Salomone Di Saverio; Massimo Sartelli; Dieter Weber; Luca Ansaloni; Walter Biffl; Helene Corte; Imtaz Wani; Gianluca Baiocchi; Pierre Cattan; Fausto Catena; Luigi Bonavina Journal: World J Emerg Surg Date: 2019-05-31 Impact factor: 5.469