Early colonoscopy
ProcedurePerformance of prepared colonoscopy within 24 h of arrival
NCT Number: NCT03098173
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.
Looking for future studies?
Notify Me20 year and older
All sexes
Interventional
Not applicable
Aichi Cancer Center Hospital, Nagoya, Aichi-ken, Japan
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
An individual who meets any of the following criteria will be excluded from participation in this study:
Performance of prepared colonoscopy within 24 h of arrival
Performance of prepared colonoscopy between 24 and 96 h after arrival
Time frame: 0-4 day
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 will be defined as the number achieving hemostasis per total number of attempts at endoscopic hemostasis during colonoscopy examination.
Time frame: 0-34 day
Additional endoscopic examinations will be defined as examinations to achieve hemostasis.
Time frame: 0-34 day
It will be defined as radiology intervention to achieve hemostasis.
Time frame: 0-34 day
It will be defined as surgery to achieve hemostasis.
Time frame: 30 day
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.
Time frame: During hospitalization
It will be defined as the numbers of patients who will need transfusion.
Time frame: 0-34 day
It will be defined as length of stay to cure acute lower gastrointestinal bleeding.
Time frame: 30 day
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 from enrollment
Time frame: 0-4 day
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
Colonoscopy-related adverse events will include hemorrhagic shock, and perforation.
Tokyo University
Other
A Multi-center, Randomized Controlled Trial Comparing Early Versus Elective Colonoscopy in Outpatients With Acute Lower Gastrointestinal Bleeding
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06254443
Acute Lower Gastrointestinal Bleeding
Tongliao, Neimenggu, China
View Trial Details