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Comparing Early Versus Elective Colonoscopy

Primary Purpose

Acute Lower Gastrointestinal Bleeding

Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Early colonoscopy
Elective colonoscopy
Sponsored by
Tokyo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Lower Gastrointestinal Bleeding focused on measuring Early colonoscopy, Stigmata of recent hemorrhage, Rebleeding

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.
  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.

Sites / Locations

  • Aichi Cancer Center Hospital
  • Hirosaki University Hospital
  • National Center for Global Health and Medicine kohnodai hospital
  • Fukui prefectural hospital
  • National Hospital Organization Hakodate Hospital
  • Otaru Ekisaikai Hospital
  • Tonan Hospital
  • Ishikawa prefectural central hospital
  • Nagasaki Harbor Medical Center City Hospital
  • Japan Community Healthcare Organization Osaka Hospital
  • Toyonaka Municipal Hospital
  • The University of Tokyo
  • St. Luke's International Hospital
  • National Center for Global Health and Medicine center hospital
  • Shuto General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Early colonoscopy

Elective colonoscopy

Arm Description

Performance of prepared colonoscopy within 24 h of arrival

Performance of prepared colonoscopy between 24 and 96 h after arrival

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Need for Additional Endoscopic Examinations
Additional endoscopic examinations will be defined as examinations to achieve hemostasis.
Need for Interventional Radiology
It will be defined as radiology intervention to achieve hemostasis.
Need for Surgery
It will be defined as surgery to achieve hemostasis.
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.
Need for Transfusion During Hospitalization
It will be defined as the numbers of patients who will need transfusion.
Length of Stay
It will be defined as length of stay to cure acute lower gastrointestinal bleeding.
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.
Number of Participants With Thirty-day Death Events
Number of Participants with Thirty-day death Events from enrollment
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
Number of Participants With Colonoscopy-related Adverse Events
Colonoscopy-related adverse events will include hemorrhagic shock, and perforation.

Full Information

First Posted
March 26, 2017
Last Updated
October 21, 2019
Sponsor
Tokyo University
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1. Study Identification

Unique Protocol Identification Number
NCT03098173
Brief Title
Comparing Early Versus Elective Colonoscopy
Official Title
A Multi-center, Randomized Controlled Trial Comparing Early Versus Elective Colonoscopy in Outpatients With Acute Lower Gastrointestinal Bleeding
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
January 29, 2016 (Actual)
Primary Completion Date
August 24, 2018 (Actual)
Study Completion Date
January 4, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tokyo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lower Gastrointestinal Bleeding
Keywords
Early colonoscopy, Stigmata of recent hemorrhage, Rebleeding

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel, randomized, superiority trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
162 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early colonoscopy
Arm Type
Experimental
Arm Description
Performance of prepared colonoscopy within 24 h of arrival
Arm Title
Elective colonoscopy
Arm Type
Active Comparator
Arm Description
Performance of prepared colonoscopy between 24 and 96 h after arrival
Intervention Type
Procedure
Intervention Name(s)
Early colonoscopy
Intervention Description
Performance of prepared colonoscopy within 24 h of arrival
Intervention Type
Procedure
Intervention Name(s)
Elective colonoscopy
Intervention Description
Performance of prepared colonoscopy between 24 and 96 h after arrival
Primary Outcome Measure Information:
Title
Stigmata of Recent Hemorrhage (SRH) Identification Rate
Description
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.
Time Frame
0-4 day
Secondary Outcome Measure Information:
Title
Success Rate of Endoscopic Treatment; Number of Participants Achieving Hemostasis With Endoscopic Treatment
Description
Success rate will be defined as the number achieving hemostasis per total number of attempts at endoscopic hemostasis during colonoscopy examination.
Time Frame
0-4 day
Title
Need for Additional Endoscopic Examinations
Description
Additional endoscopic examinations will be defined as examinations to achieve hemostasis.
Time Frame
0-34 day
Title
Need for Interventional Radiology
Description
It will be defined as radiology intervention to achieve hemostasis.
Time Frame
0-34 day
Title
Need for Surgery
Description
It will be defined as surgery to achieve hemostasis.
Time Frame
0-34 day
Title
Thirty-day Rebleeding Rates
Description
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.
Time Frame
30 day
Title
Need for Transfusion During Hospitalization
Description
It will be defined as the numbers of patients who will need transfusion.
Time Frame
During hospitalization
Title
Length of Stay
Description
It will be defined as length of stay to cure acute lower gastrointestinal bleeding.
Time Frame
0-34 day
Title
Number of Participants With Thirty-day Thrombosis Events
Description
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.
Time Frame
30 day
Title
Number of Participants With Thirty-day Death Events
Description
Number of Participants with Thirty-day death Events from enrollment
Time Frame
30 day
Title
Number of Participants With Preparation-related Adverse Events
Description
Preparation-related adverse events will include nausea, vomiting, abdominal pain, volume overload, aspiration pneumonia, hemorrhagic shock, exacerbation bleeding, and ileus
Time Frame
0-4 day
Title
Number of Participants With Colonoscopy-related Adverse Events
Description
Colonoscopy-related adverse events will include hemorrhagic shock, and perforation.
Time Frame
0-4 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Provision of signed and dated informed consent form. 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: Patients with hematemesis, black vomiting, or melena. Patients with upper gastrointestinal bleeding, diagnosed by nasogastric tube or upper endoscopy. Patients who have impossible consumed the oral bowel preparation solution. Patients who have undergone computed tomography. Patients who have been diagnosed with peptic ulcer diseases within the previous 10 days. Ulcerative colitis or Crohn's disease patients. Patients who have undergone abdominal surgery within the previous 10 days. Patients who have undergone polypectomy, endoscopic mucosal resection, or endoscopic submucosal dissection of the lower gastrointestinal tract within the previous 10 days. Patients with suspected perforation or peritonitis. Patients with suspected intestinal obstruction. Patients with hemorrhagic shock refractory to infusion or blood transfusion. Patients who have undergone total colectomy. Patients with suspected disseminated intravascular coagulation. Patients with end-stage malignant disease. Patients with severe cardiac failure. Patients with active thrombosis. Patients with severe respiratory failure. Pregnant patients.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Atsuo Yamada, MD
Organizational Affiliation
Tokyo University
Official's Role
Study Director
Facility Information:
Facility Name
Aichi Cancer Center Hospital
City
Nagoya-shi
State/Province
Aichi
Country
Japan
Facility Name
Hirosaki University Hospital
City
Hirosaki-shi
State/Province
Aomori
Country
Japan
Facility Name
National Center for Global Health and Medicine kohnodai hospital
City
Ichikawa-shi
State/Province
Chiba
Country
Japan
Facility Name
Fukui prefectural hospital
City
Fukui-shi
State/Province
Fukui
Country
Japan
Facility Name
National Hospital Organization Hakodate Hospital
City
Hakodate-shi
State/Province
Hokkaido
Country
Japan
Facility Name
Otaru Ekisaikai Hospital
City
Otaru-shi
State/Province
Hokkaido
Country
Japan
Facility Name
Tonan Hospital
City
Sapporo-shi
State/Province
Hokkaido
Country
Japan
Facility Name
Ishikawa prefectural central hospital
City
Kanazawa city
State/Province
Ishikawa
Country
Japan
Facility Name
Nagasaki Harbor Medical Center City Hospital
City
Nagasaki-shi
State/Province
Nagasaki
Country
Japan
Facility Name
Japan Community Healthcare Organization Osaka Hospital
City
Fukushima-shi
State/Province
Osaka
Country
Japan
Facility Name
Toyonaka Municipal Hospital
City
Toyonaka-shi
State/Province
Osaka
Country
Japan
Facility Name
The University of Tokyo
City
Bunkyo-ku
State/Province
Tokyo
Country
Japan
Facility Name
St. Luke's International Hospital
City
Chuo-ku
State/Province
Tokyo
Country
Japan
Facility Name
National Center for Global Health and Medicine center hospital
City
Shinjuku-ku
State/Province
Tokyo
Country
Japan
Facility Name
Shuto General Hospital
City
Yanai-shi
State/Province
Yamaguchi
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28042393
Citation
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.
Results Reference
background
PubMed Identifier
31563627
Citation
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.
Results Reference
derived
PubMed Identifier
29615078
Citation
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.
Results Reference
derived
Links:
URL
http://www.todai-shoukakan.com/cont4/29.html
Description
Early versus Elective Colonoscopy Trial
Available IPD and Supporting Information:
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
http://www.todai-shoukakan.com/cont4/29.html

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Comparing Early Versus Elective Colonoscopy

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