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Comparing Early Versus Elective Colonoscopy

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ClinicalTrials.gov Identifier: NCT03098173
Recruitment Status : Active, not recruiting
First Posted : March 31, 2017
Last Update Posted : September 13, 2018
Sponsor:
Information provided by (Responsible Party):
Atsuo Yamada, Tokyo University

Brief 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.

Condition or disease Intervention/treatment Phase
Acute Lower Gastrointestinal Bleeding Procedure: Early colonoscopy Procedure: Elective colonoscopy Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 162 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel, randomized, superiority trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-center, Randomized Controlled Trial Comparing Early Versus Elective Colonoscopy in Outpatients With Acute Lower Gastrointestinal Bleeding
Actual Study Start Date : January 29, 2016
Actual Primary Completion Date : August 24, 2018
Estimated Study Completion Date : May 4, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Early colonoscopy
Performance of prepared colonoscopy within 24 h of arrival
Procedure: Early colonoscopy
Performance of prepared colonoscopy within 24 h of arrival

Active Comparator: Elective colonoscopy
Performance of prepared colonoscopy between 24 and 96 h after arrival
Procedure: Elective colonoscopy
Performance of prepared colonoscopy between 24 and 96 h after arrival




Primary Outcome Measures :
  1. SRH identification rate [ Time Frame: 0-4 day ]
    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.


Secondary Outcome Measures :
  1. Success rate of endoscopic treatment [ 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.

  2. Need for additional endoscopic examinations [ Time Frame: 0-34 day ]
  3. Need for interventional radiology [ Time Frame: 0-34 day ]
  4. Need for surgery [ Time Frame: 0-34 day ]
  5. Thirty-day rebleeding rates [ 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.


  6. Need for transfusion during hospitalization [ Time Frame: During hospitalization ]
  7. Length of stay [ Time Frame: 0-34 day ]
  8. Thirty-day thrombosis events [ 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.

  9. Thirty-day mortality [ Time Frame: 30 day ]
  10. Preparation-related adverse events [ 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

  11. Colonoscopy-related adverse events [ Time Frame: 0-4 day ]
    Colonoscopy-related adverse events will include hemorrhagic shock, and perforation.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03098173


Locations
Japan
Aichi Cancer Center Hospital
Nagoya-shi, Aichi, 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-shi, Hokkaido, Japan
Ishikawa prefectural central hospital
Kanazawa city, Ishikawa, Japan
Nagasaki Harbor Medical Center City Hospital
Nagasaki-shi, 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
Sponsors and Collaborators
Tokyo University
Investigators
Study Director: Atsuo Yamada, MD Tokyo University

Additional Information:
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Atsuo Yamada, Department of Gastroenterology, Tokyo University
ClinicalTrials.gov Identifier: NCT03098173     History of Changes
Other Study ID Numbers: P2015034-11Y
UMIN000021129 ( Other Identifier: University hospital Medical Information Network )
First Posted: March 31, 2017    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Atsuo Yamada, Tokyo University:
Early colonoscopy
Stigmata of recent hemorrhage
Rebleeding

Additional relevant MeSH terms:
Hemorrhage
Gastrointestinal Hemorrhage
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases