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| ID | Type | Description | Link |
|---|---|---|---|
| UMIN000021129 | Other Identifier | University hospital Medical Information Network |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early colonoscopy | Experimental | Performance of prepared colonoscopy within 24 h of arrival |
|
| Elective colonoscopy | Active Comparator | Performance of prepared colonoscopy between 24 and 96 h after arrival |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early colonoscopy | Procedure | Performance of prepared colonoscopy within 24 h of arrival |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
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| Name | Affiliation | Role |
|---|---|---|
| Atsuo Yamada, MD | Tokyo University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aichi Cancer Center Hospital | Nagoya | Aichi-ken | Japan | |||
| Hirosaki University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28042393 | Background | 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. | |
| 31563627 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Early Colonoscopy | Performance of prepared colonoscopy within 24 h of arrival Early colonoscopy: Performance of prepared colonoscopy within 24 h of arrival |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Early Colonoscopy | Performance of prepared colonoscopy within 24 h of arrival Early colonoscopy: Performance of prepared colonoscopy within 24 h of arrival |
| BG001 | Elective Colonoscopy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The primary analysis included a modified intention-to-treat population, excluding the following patients from the genuine intention-to-treat analysis set: 1) those who did not satisfy the enrollment criteria after randomization; 2) those who provided no post-randomization data on primary outcome; and 3) those who did not undergo colonoscopy | Posted | Count of Participants | Participants | 0-4 day |
|
30 day
Data will be entered into a web-based EDC system by trial investigators or site investigators.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Early Colonoscopy | Performance of prepared colonoscopy within 24 h of arrival Early colonoscopy: Performance of prepared colonoscopy within 24 h of arrival |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoxemia | General disorders | MedDRA 22.0 | Systematic Assessment |
Non blinding
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ryota Niikura | Tokyo University | +81-3-3815-5411 | niikura-dky@umin.ac.jp |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 9, 2018 | Apr 16, 2019 | Prot_SAP_000.pdf |
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Parallel, randomized, superiority trial
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| Elective colonoscopy | Procedure | Performance of prepared colonoscopy between 24 and 96 h after arrival |
|
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 |
| 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 |
| 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. |
| 29615078 | Derived | 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. |
Performance of prepared colonoscopy between 24 and 96 h after arrival
Elective colonoscopy: Performance of prepared colonoscopy between 24 and 96 h after arrival
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Body mass index | Mean | Standard Deviation | kg/m^2 |
|
| Previous lower GI bleeding | Count of Participants | Participants |
|
| Ischemic heart disease | Count of Participants | Participants |
|
| Chronic obstructive pulmonary disease | Count of Participants | Participants |
|
| Peptic ulcer | Count of Participants | Participants |
|
| Liver cirrhosis | Count of Participants | Participants |
|
| Diabetes mellitus | Count of Participants | Participants |
|
| Chronic heart failure | Count of Participants | Participants |
|
| Cerebrovascular disease | Count of Participants | Participants |
|
| Dementia | Count of Participants | Participants |
|
| Collagen disease | Count of Participants | Participants |
|
| Chronic kidney disease | Count of Participants | Participants |
|
| Leukemia | Count of Participants | Participants |
|
| Malignant lymphoma | Count of Participants | Participants |
|
| Solid cancer | Count of Participants | Participants |
|
| Low-dose aspirin | Count of Participants | Participants |
|
| Thienopyridine | Count of Participants | Participants |
|
| Cilostazol | Count of Participants | Participants |
|
| Other antiplatelet drugs | Count of Participants | Participants |
|
| Warfarin | Count of Participants | Participants |
|
| Direct oral anticoagulants | Count of Participants | Participants |
|
| NSAIDs | Count of Participants | Participants |
|
| Hemodynamic instability | Count of Participants | Participants |
|
| Hemoglobin | Mean | Standard Deviation | g/dL |
|
| Upper GI endoscopy before colonoscopy | Count of Participants | Participants |
|
| Expert endoscopist | Count of Participants | Participants |
|
| Cecal insertion | Count of Participants | Participants |
|
| Cecal insertion time | Mean | Standard Deviation | minutes |
|
| Total procedure time | Mean | Standard Deviation | minutes |
|
| Bleeding source | Number | participants |
|
| OG001 | 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 |
|
|
| Secondary | 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. | Success rate of endoscopic treatment was defined as achievement of hemostasis (early for 15 patients and elective for 15 patients). | Posted | Count of Participants | Participants | 0-4 day |
|
|
|
| Secondary | Need for Additional Endoscopic Examinations | Additional endoscopic examinations will be defined as examinations to achieve hemostasis. | Posted | Count of Participants | Participants | 0-34 day |
|
|
|
| Secondary | Need for Interventional Radiology | It will be defined as radiology intervention to achieve hemostasis. | Posted | Count of Participants | Participants | 0-34 day |
|
|
|
| Secondary | Need for Surgery | It will be defined as surgery to achieve hemostasis. | Posted | Count of Participants | Participants | 0-34 day |
|
|
|
| Secondary | 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. | Rebleeding,thrombotic events, and mortality were evaluated for patients who approximately met the 30-day follow-up criteria (early colonoscopy for 72 patients and elective colonoscopy for 75 patients). | Posted | Count of Participants | Participants | 30 day |
|
|
|
| Secondary | Need for Transfusion During Hospitalization | It will be defined as the numbers of patients who will need transfusion. | Posted | Count of Participants | Participants | During hospitalization |
|
|
|
| Secondary | Length of Stay | It will be defined as length of stay to cure acute lower gastrointestinal bleeding. | Posted | Mean | Standard Deviation | days | 0-34 day |
|
|
|
| Secondary | 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. | Rebleeding,thrombotic events, and mortality were evaluated for patients who approximately met the 30-day follow-up criteria (early colonoscopy for 72 patients and elective colonoscopy for 75 patients). | Posted | Count of Participants | Participants | 30 day |
|
|
|
| Secondary | Number of Participants With Thirty-day Death Events | Number of Participants with Thirty-day death Events from enrollment | Posted | Count of Participants | Participants | 30 day |
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | 0-4 day |
|
|
|
| Secondary | Number of Participants With Colonoscopy-related Adverse Events | Colonoscopy-related adverse events will include hemorrhagic shock, and perforation. | Posted | Count of Participants | Participants | 0-4 day |
|
|
|
| 0 |
| 79 |
| 2 |
| 79 |
| 9 |
| 79 |
| EG001 | 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 | 0 | 80 | 0 | 80 | 8 | 80 |
| Bacterial cellulitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Upper respiratory inflammation | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Pseudogout | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Acute prostatitis | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
|
| Vagal reflex | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Hypoglycemia | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Pyrexia | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Arthritis pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Abdominal bloating | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
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