This multi-center, randomized controlled trial study is planned to include 162 outpatients with onset of acute lower gastrointestinal bleeding to compare the rate of identification of stigmata of recent hemorrhage (SRH), and other clinical outcomes, including the 30-day rebleeding rate, between 'early' colonoscopy and 'elective' colonoscopy.
All patients will receive early colonoscopy or elective colonoscopy, but they do so by different timing. Early colonoscopy will be performed within 24 h of the initial visit. Elective colonoscopy will be performed between 24 and 96 h after the initial visit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
162
Performance of prepared colonoscopy within 24 h of arrival
Performance of prepared colonoscopy between 24 and 96 h after arrival
Aichi Cancer Center Hospital
Nagoya, Aichi-ken, Japan
Hirosaki University Hospital
Hirosaki-shi, Aomori, Japan
National Center for Global Health and Medicine kohnodai hospital
Ichikawa-shi, Chiba, Japan
Stigmata of Recent Hemorrhage (SRH) Identification Rate
Stigmata of Recent Hemorrhage (SRH) based on colonoscopic visualization of lesions, such as diverticulosis, tumor, ulcer, hemorrhoid, angioectasia, and polyps exhibiting active bleeding, a visible vessel, or an adherent clot.
Time frame: 0-4 day
Success Rate of Endoscopic Treatment; Number of Participants Achieving Hemostasis With Endoscopic Treatment
Success rate will be defined as the number achieving hemostasis per total number of attempts at endoscopic hemostasis during colonoscopy examination.
Time frame: 0-4 day
Need for Additional Endoscopic Examinations
Additional endoscopic examinations will be defined as examinations to achieve hemostasis.
Time frame: 0-34 day
Need for Interventional Radiology
It will be defined as radiology intervention to achieve hemostasis.
Time frame: 0-34 day
Need for Surgery
It will be defined as surgery to achieve hemostasis.
Time frame: 0-34 day
Thirty-day Rebleeding Rates
Rebleeding will be defined as significant fresh blood loss after an initial colonoscopy with any of the following criteria: i) Hemorrhagic shock, including cold sweat, nausea, syncope, or systolic blood pressure ≤ 90 mmHg. ii) Need for transfusion, according to the guidelines of the Ministry of Health, Labour, and Welfare. iii) Further colonoscopy identifies blood pooling, or iv) SRH in the lower gastrointestinal tract. v) Contrast-enhanced CT identifies extravasation in the colorectal region. However, these examinations will not be performed routinely if rebleeding occurs in the study period.
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Fukui prefectural hospital
Fukui-shi, Fukui, Japan
National Hospital Organization Hakodate Hospital
Hakodate-shi, Hokkaido, Japan
Otaru Ekisaikai Hospital
Otaru-shi, Hokkaido, Japan
Tonan Hospital
Sapporo, Hokkaido, Japan
Ishikawa prefectural central hospital
Kanazawa, Ishikawa-ken, Japan
Nagasaki Harbor Medical Center City Hospital
Nagasaki, Nagasaki, Japan
Japan Community Healthcare Organization Osaka Hospital
Fukushima-shi, Osaka, Japan
...and 5 more locations
Time frame: 30 day
Need for Transfusion During Hospitalization
It will be defined as the numbers of patients who will need transfusion.
Time frame: During hospitalization
Length of Stay
It will be defined as length of stay to cure acute lower gastrointestinal bleeding.
Time frame: 0-34 day
Number of Participants With Thirty-day Thrombosis Events
Thrombosis events will include acute coronary syndromes, including angina pectoris and myocardial infarction, stroke, including cerebrovascular infarction, cerebral hemorrhage, and transient ischemic attacks, deep vein thrombosis, and pulmonary embolism.
Time frame: 30 day
Number of Participants With Thirty-day Death Events
Number of Participants with Thirty-day death Events from enrollment
Time frame: 30 day
Number of Participants With Preparation-related Adverse Events
Preparation-related adverse events will include nausea, vomiting, abdominal pain, volume overload, aspiration pneumonia, hemorrhagic shock, exacerbation bleeding, and ileus
Time frame: 0-4 day
Number of Participants With Colonoscopy-related Adverse Events
Colonoscopy-related adverse events will include hemorrhagic shock, and perforation.
Time frame: 0-4 day