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Comparing Early Versus Elective Colonoscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03098173
Recruitment Status : Completed
First Posted : March 31, 2017
Results First Posted : November 8, 2019
Last Update Posted : November 8, 2019
Sponsor:
Information provided by (Responsible Party):
Atsuo Yamada, Tokyo University

Tracking Information
First Submitted Date  ICMJE March 26, 2017
First Posted Date  ICMJE March 31, 2017
Results First Submitted Date  ICMJE September 26, 2019
Results First Posted Date  ICMJE November 8, 2019
Last Update Posted Date November 8, 2019
Actual Study Start Date  ICMJE January 29, 2016
Actual Primary Completion Date August 24, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 21, 2019)
Stigmata of Recent Hemorrhage (SRH) Identification Rate [ Time Frame: 0-4 day ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 27, 2017)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 21, 2019)
  • Success Rate of Endoscopic Treatment; Number of Participants Achieving Hemostasis With 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.
  • Need for Additional Endoscopic Examinations [ Time Frame: 0-34 day ]
    Additional endoscopic examinations will be defined as examinations to achieve hemostasis.
  • Need for Interventional Radiology [ Time Frame: 0-34 day ]
    It will be defined as radiology intervention to achieve hemostasis.
  • Need for Surgery [ Time Frame: 0-34 day ]
    It will be defined as surgery to achieve hemostasis.
  • 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.
  • Need for Transfusion During Hospitalization [ Time Frame: During hospitalization ]
    It will be defined as the numbers of patients who will need transfusion.
  • Length of Stay [ Time Frame: 0-34 day ]
    It will be defined as length of stay to cure acute lower gastrointestinal bleeding.
  • Number of Participants With 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.
  • Number of Participants With Thirty-day Death Events [ Time Frame: 30 day ]
    Number of Participants with Thirty-day death Events from enrollment
  • Number of Participants With 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
  • Number of Participants With Colonoscopy-related Adverse Events [ Time Frame: 0-4 day ]
    Colonoscopy-related adverse events will include hemorrhagic shock, and perforation.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 27, 2017)
  • 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.
  • Need for Additional Endoscopic Examinations [ Time Frame: 0-34 day ]
  • Need for Interventional Radiology [ Time Frame: 0-34 day ]
  • Need for Surgery [ Time Frame: 0-34 day ]
  • 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.
  • Need for Transfusion During Hospitalization [ Time Frame: During hospitalization ]
  • Length of Stay [ Time Frame: 0-34 day ]
  • 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.
  • Thirty-day mortality [ Time Frame: 30 day ]
  • 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
  • Colonoscopy-related adverse events [ Time Frame: 0-4 day ]
    Colonoscopy-related adverse events will include hemorrhagic shock, and perforation.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparing Early Versus Elective Colonoscopy
Official Title  ICMJE A Multi-center, Randomized Controlled Trial Comparing Early Versus Elective Colonoscopy in Outpatients With Acute Lower Gastrointestinal Bleeding
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Parallel, randomized, superiority trial
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Lower Gastrointestinal Bleeding
Intervention  ICMJE
  • Procedure: Early colonoscopy
    Performance of prepared colonoscopy within 24 h of arrival
  • Procedure: Elective colonoscopy
    Performance of prepared colonoscopy between 24 and 96 h after arrival
Study Arms  ICMJE
  • Experimental: Early colonoscopy
    Performance of prepared colonoscopy within 24 h of arrival
    Intervention: Procedure: Early colonoscopy
  • Active Comparator: Elective colonoscopy
    Performance of prepared colonoscopy between 24 and 96 h after arrival
    Intervention: Procedure: Elective colonoscopy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 27, 2017)
162
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 4, 2019
Actual Primary Completion Date August 24, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03098173
Other Study ID Numbers  ICMJE P2015034-11Y
UMIN000021129 ( Other Identifier: University hospital Medical Information Network )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Atsuo Yamada, Tokyo University
Study Sponsor  ICMJE Tokyo University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Atsuo Yamada, MD Tokyo University
PRS Account Tokyo University
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP