A multicenter, randomized controlled trial comparing the identification rate of stigmata of recent hemorrhage and rebleeding rate between early and elective colonoscopy in outpatient-onset acute lower gastrointestinal bleeding: study protocol for a randomized controlled trial
Ryota Niikura,
Naoyoshi Nagata,
Atsuo Yamada,
Hisashi Doyama,
Yasutoshi Shiratori,
Tsutomu Nishida,
Shu Kiyotoki,
Tomoyuki Yada,
Tomoki Fujita,
Tetsuya Sumiyoshi,
Kenkei Hasatani,
Tatsuya Mikami,
Tetsuro Honda,
Katsuhiro Mabe,
Kazuo Hara,
Katsumi Yamamoto,
Mariko Takeda,
Munenori Takata,
Mototsugu Tanaka,
Tomohiro Shinozaki,
Mitsuhiro Fujishiro,
Kazuhiko Koike
Affiliations
Ryota Niikura
Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo
Naoyoshi Nagata
Department of Gastroenterology and Hepatology, National Center for Global Health and Medicine
Atsuo Yamada
Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo
Hisashi Doyama
Department of Gastroenterology, Ishikawa Prefectural Central Hospital
Yasutoshi Shiratori
Department of Gastroenterology, St. Luke’s International Hospital
Tsutomu Nishida
Department of Gastroenterology, Toyonaka Municipal Hospital
Shu Kiyotoki
Department of Gastroenterology, Shuto General Hospital
Tomoyuki Yada
Department of Gastroenterology and Hepatology, National Center for Global Health and Medicine Kohnodai Hospital
Tomoki Fujita
Department of Gastroenterology, Otaru Ekisaikai Hospital
Tetsuya Sumiyoshi
The Center for Digestive Disease, Tonan Hospital
Kenkei Hasatani
Department of Gastroenterology, Fukui Prefectural Hospital
Tatsuya Mikami
Division of Endoscopy, Hirosaki University Hospital
Tetsuro Honda
Department of Gastroenterology, Nagasaki Harbor Medical Center City Hospital
Katsuhiro Mabe
Department of Gastroenterology, National Hospital Organization Hakodate Hospital
Kazuo Hara
Department of Gastroenterology, Aichi Cancer Center Hospital
Katsumi Yamamoto
Department of Gastroenterology, Japan Community Healthcare Organization Osaka Hospital
Mariko Takeda
Clinical Research Support Center, The University of Tokyo Hospital
Munenori Takata
Clinical Research Support Center, The University of Tokyo Hospital
Mototsugu Tanaka
Clinical Research Support Center, The University of Tokyo Hospital
Tomohiro Shinozaki
Department of Biostatistics, School of Public Health, The University of Tokyo
Mitsuhiro Fujishiro
Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo
Kazuhiko Koike
Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo
Abstract Background The clinical benefit of early colonoscopy within 24 h of arrival in patients with severe acute lower gastrointestinal bleeding (ALGIB) remains controversial. This trial will compare early colonoscopy (performed within 24 h) versus elective colonoscopy (performed between 24 and 96 h) to examine the identification rate of stigmata of recent hemorrhage (SRH) in ALGIB patients. We hypothesize that, compared with elective colonoscopy, early colonoscopy increases the identification of SRH and subsequently improves clinical outcomes. Methods This trial is an investigator-initiated, multicenter, randomized, open-label, parallel-group trial examining the superiority of early colonoscopy over elective colonoscopy (standard therapy) in ALGIB patients. The primary outcome measure is the identification of SRH. Secondary outcomes include 30-day rebleeding, success of endoscopic treatment, need for additional endoscopic examination, need for interventional radiology, need for surgery, need for transfusion during hospitalization, length of stay, 30-day thrombotic events, 30-day mortality, preparation-related adverse events, and colonoscopy-related adverse events. The sample size will enable detection of a 9% SRH rate in elective colonoscopy patients and a SRH rate of ≥ 26% in early colonoscopy patients with a risk of type I error of 5% and a power of 80%. Discussion This trial will provide high-quality data on the benefits and risks of early colonoscopy in ALGIB patients. Trial registration UMIN-CTR Identifier, UMIN000021129. Registered on 21 February 2016; ClinicalTrials.gov Identifier, NCT03098173. Registered on 24 March 2017.
