Comparing Early Versus Elective Colonoscopy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Multi-center, Randomized Controlled Trial Comparing Early Versus Elective Colonoscopy in Outpatients With Acute Lower Gastrointestinal Bleeding

Conditions
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Acute Lower Gastrointestinal Bleeding

Intervention / Treatment
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* Procedure: Early colonoscopy
* Procedure: Elective colonoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or females aged ≥ 20 years, presenting with moderate-to-severe hematochezia or melena within 24 h of arrival, defined as (i) more than three occurrences of hematochezia within 8 h, (ii) hemorrhagic shock, or (iii) requiring transfusion. Provision of signed and dated informed consent form. Stated willingness to comply with all study procedures and availability for the duration of the study. Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in this study: Patients with hematemesis, black vomiting, or melena. Patients with upper gastrointestinal bleeding, diagnosed by nasogastric tube or upper endoscopy. Patients who have impossible consumed the oral bowel preparation solution. Patients who have undergone computed tomography. Patients who have been diagnosed with peptic ulcer diseases within the previous 10 days. Ulcerative colitis or Crohn's disease patients. Patients who have undergone abdominal surgery within the previous 10 days. Patients who have undergone polypectomy, endoscopic mucosal resection, or endoscopic submucosal dissection of the lower gastrointestinal tract within the previous 10 days. Patients with suspected perforation or peritonitis. Patients with suspected intestinal obstruction. Patients with hemorrhagic shock refractory to infusion or blood transfusion. Patients who have undergone total colectomy. Patients with suspected disseminated intravascular coagulation. Patients with end-stage malignant disease. Patients with severe cardiac failure. Patients with active thrombosis. Patients with severe respiratory failure. Pregnant patients.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel, randomized, superiority trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early colonoscopy<br>Performance of prepared colonoscopy within 24 h of arrival | Procedure: Early colonoscopy<br>* Performance of prepared colonoscopy within 24 h of arrival<br>|
| Active Comparator: Elective colonoscopy<br>Performance of prepared colonoscopy between 24 and 96 h after arrival | Procedure: Elective colonoscopy<br>* Performance of prepared colonoscopy between 24 and 96 h after arrival<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 0-4 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 0-4 day | 
| Need for Additional Endoscopic Examinations | Additional endoscopic examinations will be defined as examinations to achieve hemostasis. | 0-34 day | 
| Need for Interventional Radiology | It will be defined as radiology intervention to achieve hemostasis. | 0-34 day | 
| Need for Surgery | It will be defined as surgery to achieve hemostasis. | 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. | 30 day | 
| Need for Transfusion During Hospitalization | It will be defined as the numbers of patients who will need transfusion. | During hospitalization | 
| Length of Stay | It will be defined as length of stay to cure acute lower gastrointestinal bleeding. | 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. | 30 day | 
| Number of Participants With Thirty-day Death Events | Number of Participants with Thirty-day death Events from enrollment | 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 | 0-4 day | 
| Number of Participants With Colonoscopy-related Adverse Events | Colonoscopy-related adverse events will include hemorrhagic shock, and perforation. | 0-4 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Early colonoscopy, Stigmata of recent hemorrhage, Rebleeding