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

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.

Keywords: Acute lower gastrointestinal bleeding; Early colonoscopy; Elective colonoscopy; Hemostasis; Rebleeding; Stigmata of recent hemorrhage.

Conflict of interest statement

Authors’ information

See Additional file 1: Appendix S4.

Ethics approval and consent to participate

The Institutional Review Boards of the University of Tokyo, National Center for Global Health and Medicine, Ishikawa Prefectural Central Hospital, St. Luke’s International Hospital, Toyonaka Municipal Hospital, Shuto General Hospital, National Center for Global Health and Medicine Kohnodai Hospital, Otaru Ekisaikai Hospital, Tonan Hospital, Fukui Prefectural Hospital, Hirosaki University Hospital, Nagasaki Harbor Medical Center City Hospital, National Hospital Organization Hakodate Hospital, Aichi Cancer Center Hospital, and Japan Community Healthcare Organization Osaka Hospital approved our trial. We will obtain informed consent from all participants in the study.

Consent for publication

The Principal Investigator will form a Publication Committee for this purpose, which will include key members of the Trial Steering Committee, and the Committee will grant authorship according to individual input according to the Vancouver Protocol of the International Committee of Medical Journal Editors. Investigators who do not qualify for authorship will be acknowledged by name in the final manuscript.

Competing interests

M. Fujishiro has received lecture honoraria from Takeda Pharmaceutical Co., AstraZeneka Pharmaceuticals, Zeria Pharmaceutical Co., and Daiichi-Sankyo Co., research grants for unrestricted purpose from Takeda Pharmaceutical Co. and EA Pharma Co., and collaborative funding from HOYA-Pentax Co. The other authors declare no competing interests.

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Figures

Fig. 1

Schematic of study design

Fig. 2

Timeline