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Comparing Early Versus Elective Colonoscopy | Clinical Trials | Clareo Health

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Comparing Early Versus Elective Colonoscopy

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

NCT03098173•Tokyo University

View on ClinicalTrials.gov

Summary

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

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.

Eligibility

Age

20 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. 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.
•2. Provision of signed and dated informed consent form.
•3. 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:
•1. Patients with hematemesis, black vomiting, or melena.
•2. Patients with upper gastrointestinal bleeding, diagnosed by nasogastric tube or upper endoscopy.
•3. Patients who have impossible consumed the oral bowel preparation solution.
•4. Patients who have undergone computed tomography.
•5. Patients who have been diagnosed with peptic ulcer diseases within the previous 10 days.
•6. Ulcerative colitis or Crohn's disease patients.
•7. Patients who have undergone abdominal surgery within the previous 10 days.
•8. Patients who have undergone polypectomy, endoscopic mucosal resection, or endoscopic submucosal dissection of the lower gastrointestinal tract within the previous 10 days.
•9. Patients with suspected perforation or peritonitis.
+9 more criteria

Locations (15)

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

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

Key Dates

Start Date

January 29, 2016

Primary Completion Date

August 24, 2018

Completion Date

January 4, 2019

Last Updated

November 8, 2019

Enrollment

162

ACTUAL participants

Conditions

Acute Lower Gastrointestinal Bleeding

Interventions

Early colonoscopy

PROCEDURE

Elective colonoscopy

PROCEDURE