Ryota Niikura1, Naoyoshi Nagata2, Atsuo Yamada3, Tetsuro Honda4, Kenkei Hasatani5, Naoki Ishii6, Yasutoshi Shiratori6, Hisashi Doyama7, Tsutomu Nishida8, Tetsuya Sumiyoshi9, Tomoki Fujita10, Shu Kiyotoki11, Tomoyuki Yada12, Katsumi Yamamoto13, Tomohiro Shinozaki14, Munenori Takata15, Tatsuya Mikami16, Katsuhiro Mabe17, Kazuo Hara18, Mitsuhiro Fujishiro19, Kazuhiko Koike1. 1. Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Bunkyo-ku, Tokyo, Japan. 2. Department of Gastroenterology and Hepatology, National Center for Global Health and Medicine, Shinjuku-ku, Tokyo, Japan; Gastroenterological Endoscopy, Tokyo Medical University, Shinjuku-ku, Tokyo, Japan. 3. Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Bunkyo-ku, Tokyo, Japan. Electronic address: yamada-a@umin.ac.jp. 4. Department of Gastroenterology, Nagasaki Harbor Medical Center, Nagasaki-shi, Nagasaki, Japan. 5. Department of Gastroenterology, Fukui Prefectural Hospital, Fukui-shi, Fukui, Japan. 6. Department of Gastroenterology, St. Luke's International Hospital, Chuo-ku, Tokyo, Japan. 7. Department of Gastroenterology, Ishikawa Prefectural Central Hospital, Kanazawa-shi, Ishikawa, Japan. 8. Department of Gastroenterology, Toyonaka Municipal Hospital, Toyonaka-shi, Osaka, Japan. 9. Department of Gastroenterology, Tonan Hospital, Sapporo-shi, Hokkaido, Japan. 10. Department of Gastroenterology, Otaru Ekisaikai Hospital, Otaru-shi, Hokkaido, Japan; Department of Gastroenterology, Sapporo Century Hospital, Sapporo-shi, Hokkaido, Japan. 11. Department of Gastroenterology, Shuto General Hospital, Yanai-shi, Yamaguchi, Japan. 12. Department of Gastroenterology and Hepatology, National Center for Global Health and Medicine Kohnodai Hospital, Ichikawa-shi, Chiba, Japan. 13. Department of Gastroenterology, Japan Community Healthcare Organization Osaka Hospital, Osaka-shi, Osaka, Japan. 14. Department of Biostatistics, School of Public Health, The University of Tokyo, Bunkyo-ku, Tokyo, Japan; Department of Information and Computer Technology, Faculty of Engineering, Tokyo University of Science, Shinjuku-ku, Tokyo, Japan. 15. Clinical Research Support Center, The University of Tokyo Hospital, Bunkyo-ku, Tokyo, Japan. 16. Division of Endoscopy, Hirosaki University Hospital, Hirosaki-shi, Aomori, Japan. 17. Department of Gastroenterology, National Hospital Organization Hakodate Hospital, Hakodate-shi, Hokkaido, Japan. 18. Department of Gastroenterology, Aichi Cancer Center Hospital, Nagoya-shi, Aichi, Japan. 19. Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Bunkyo-ku, Tokyo, Japan; Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine, Nagoya, Japan.
Abstract
BACKGROUND & AIMS: We performed a large, multicenter, randomized controlled trial to determine the efficacy and safety of early colonoscopy on outcomes of patients with acute lower gastrointestinal bleeding (ALGIB). METHODS: We performed an open-label study at 15 hospitals in Japan of 170 patients with ALGIB randomly assigned (1:1) to groups that underwentearly colonoscopy (within 24 hours of initial visit to the hospital) or elective colonoscopy (24-96 hours after hospital admission). The primary outcome was identification of stigmata of recent hemorrhage (SRH). Secondary outcomes were rebleeding within 30 days, endoscopic treatment success, need for transfusion, length of stay, thrombotic events within 30 days, death within 30 days, and adverse events. RESULTS:SRH were identified in 17 of 79 patients (21.5%) in the early colonoscopy group vs 17 of 80 patients (21.3%) in the elective colonoscopy group (difference, 0.3; 95% confidence interval, -12.5 to 13.0; P = .967). Rebleeding within 30 days of hospital admission occurred in 15.3% of patients in the early colonoscopy group and 6.7% of patients in the elective colonoscopy group (difference, 8.6; 95% confidence interval, -1.4 to 18.7); there were no significant differences between groups in successful endoscopic treatment rate, transfusion rate, length of stay, thrombotic events, or death within 30 days. The adverse event of hemorrhagic shock occurred during bowel preparation in no patient in the early group vs 2 patients (2.5%) in the elective colonoscopy group. CONCLUSIONS: In a randomized controlled study, we found that colonoscopy within 24 hours after hospital admission did not increase SRH or reduce rebleeding compared with colonoscopy at 24-96 hours in patients with ALGIB. ClinicalTrials.gov, Numbers: UMIN000021129 and NCT03098173.
RCT Entities:
BACKGROUND & AIMS: We performed a large, multicenter, randomized controlled trial to determine the efficacy and safety of early colonoscopy on outcomes of patients with acute lower gastrointestinal bleeding (ALGIB). METHODS: We performed an open-label study at 15 hospitals in Japan of 170 patients with ALGIB randomly assigned (1:1) to groups that underwent early colonoscopy (within 24 hours of initial visit to the hospital) or elective colonoscopy (24-96 hours after hospital admission). The primary outcome was identification of stigmata of recent hemorrhage (SRH). Secondary outcomes were rebleeding within 30 days, endoscopic treatment success, need for transfusion, length of stay, thrombotic events within 30 days, death within 30 days, and adverse events. RESULTS: SRH were identified in 17 of 79 patients (21.5%) in the early colonoscopy group vs 17 of 80 patients (21.3%) in the elective colonoscopy group (difference, 0.3; 95% confidence interval, -12.5 to 13.0; P = .967). Rebleeding within 30 days of hospital admission occurred in 15.3% of patients in the early colonoscopy group and 6.7% of patients in the elective colonoscopy group (difference, 8.6; 95% confidence interval, -1.4 to 18.7); there were no significant differences between groups in successful endoscopic treatment rate, transfusion rate, length of stay, thrombotic events, or death within 30 days. The adverse event of hemorrhagic shock occurred during bowel preparation in no patient in the early group vs 2 patients (2.5%) in the elective colonoscopy group. CONCLUSIONS: In a randomized controlled study, we found that colonoscopy within 24 hours after hospital admission did not increase SRH or reduce rebleeding compared with colonoscopy at 24-96 hours in patients with ALGIB. ClinicalTrials.gov, Numbers: UMIN000021129 and NCT03098173.
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