Study Results
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View full resultsBasic Information
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COMPLETED
NA
162 participants
INTERVENTIONAL
2016-01-29
2019-01-04
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Early colonoscopy
Performance of prepared colonoscopy within 24 h of arrival
Early colonoscopy
Performance of prepared colonoscopy within 24 h of arrival
Elective colonoscopy
Performance of prepared colonoscopy between 24 and 96 h after arrival
Elective colonoscopy
Performance of prepared colonoscopy between 24 and 96 h after arrival
Interventions
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Early colonoscopy
Performance of prepared colonoscopy within 24 h of arrival
Elective colonoscopy
Performance of prepared colonoscopy between 24 and 96 h after arrival
Eligibility Criteria
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Inclusion Criteria
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
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.
10. Patients with suspected intestinal obstruction.
11. Patients with hemorrhagic shock refractory to infusion or blood transfusion.
12. Patients who have undergone total colectomy.
13. Patients with suspected disseminated intravascular coagulation.
14. Patients with end-stage malignant disease.
15. Patients with severe cardiac failure.
16. Patients with active thrombosis.
17. Patients with severe respiratory failure.
18. Pregnant patients.
20 Years
ALL
No
Sponsors
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Tokyo University
OTHER
Responsible Party
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Atsuo Yamada
Department of Gastroenterology
Principal Investigators
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Atsuo Yamada, MD
Role: STUDY_DIRECTOR
Tokyo University
Locations
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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
Toyonaka Municipal Hospital
Toyonaka-shi, Osaka, Japan
The University of Tokyo
Bunkyo-ku, Tokyo, Japan
St. Luke's International Hospital
Chuo-ku, Tokyo, Japan
National Center for Global Health and Medicine center hospital
Shinjuku-ku, Tokyo, Japan
Shuto General Hospital
Yanai-shi, Yamaguchi, Japan
Countries
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References
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Niikura R, Nagata N, Doyama H, Ota R, Ishii N, Mabe K, Nishida T, Hikichi T, Sumiyama K, Nishikawa J, Uraoka T, Kiyotoki S, Fujishiro M, Koike K. Current state of practice for colonic diverticular bleeding in 37 hospitals in Japan: A multicenter questionnaire study. World J Gastrointest Endosc. 2016 Dec 16;8(20):785-794. doi: 10.4253/wjge.v8.i20.785.
Niikura R, Nagata N, Yamada A, Honda T, Hasatani K, Ishii N, Shiratori Y, Doyama H, Nishida T, Sumiyoshi T, Fujita T, Kiyotoki S, Yada T, Yamamoto K, Shinozaki T, Takata M, Mikami T, Mabe K, Hara K, Fujishiro M, Koike K. Efficacy and Safety of Early vs Elective Colonoscopy for Acute Lower Gastrointestinal Bleeding. Gastroenterology. 2020 Jan;158(1):168-175.e6. doi: 10.1053/j.gastro.2019.09.010. Epub 2019 Sep 26.
Niikura R, Nagata N, Yamada A, Doyama H, Shiratori Y, Nishida T, Kiyotoki S, Yada T, Fujita T, Sumiyoshi T, Hasatani K, Mikami T, Honda T, Mabe K, Hara K, Yamamoto K, Takeda M, Takata M, Tanaka M, Shinozaki T, Fujishiro M, Koike K. A multicenter, randomized controlled trial comparing the identification rate of stigmata of recent hemorrhage and rebleeding rate between early and elective colonoscopy in outpatient-onset acute lower gastrointestinal bleeding: study protocol for a randomized controlled trial. Trials. 2018 Apr 3;19(1):214. doi: 10.1186/s13063-018-2558-y.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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UMIN000021129
Identifier Type: OTHER
Identifier Source: secondary_id
P2015034-11Y
Identifier Type: -
Identifier Source: org_study_id
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