Abstract
BackgroundThe 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.MethodsThis 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%.DiscussionThis trial will provide high-quality data on the benefits and risks of early colonoscopy in ALGIB patients.Trial registrationUMIN-CTR Identifier, UMIN000021129. Registered on 21 February 2016; ClinicalTrials.gov Identifier, NCT03098173. Registered on 24 March 2017.
Highlights
The clinical benefit of early colonoscopy within 24 h of arrival in patients with severe acute lower gastrointestinal bleeding (ALGIB) remains controversial
If this study finds that early colonoscopy is beneficial for ALGIB patients, fewer transfusions, lower rebleeding rates, and shorter hospital stays may result; in such case, early colonoscopy will become more widespread in clinical practice
Rationale Two premature randomized controlled trials (RCT) [3, 4] and one propensity matching analysis [14], which was performed at a single center, have been published on investigations of whether early colonoscopy improved identification rates of stigmata of recent hemorrhage (SRH) and clinical outcomes
Summary
Trial design This will be a parallel, randomized, open-label, superiority trial, in a 1:1 ratio, to receive early colonoscopy or elective colonoscopy (Figs. 1 and 2). A secondary analysis will be conducted with the modified intention-to-treat population to compare the secondary outcomes of success of endoscopic treatment, need for additional endoscopic examination, need for interventional radiology, need for surgery, 30day rebleeding rate, need for transfusion during hospitalization, length of stay, 30-day thrombosis events, 30-day mortality, preparation-related AEs, and colonoscopy-related AEs. A sensitivity analysis will be conducted with the perprotocol population, subgroups of patients with colonic diverticular bleeding, patients terminated from the trial because of inadequate bowel preparation, patients who underwent endoscopic hemostasis, patients with colonic diverticular bleeding and who underwent endoscopic hemostasis, patients who underwent colonoscopy by an expert, patients who underwent colonoscopy within 24 h of onset of hematochezia, and each participating site. Data sharing A file containing the clean dataset used for final analysis to determine the main results of the trial, the statistical analysis plan, an explanation of variables, and the study protocol will be made publicly accessible in an anonymized format
Sign-in/Register to view highlights & summary Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
