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Comparing Early Versus Elective Colonoscopy

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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Acute Lower Gastrointestinal Bleeding
Interventions Procedure: Early colonoscopy
Procedure: Elective colonoscopy
Enrollment 162
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Elective Colonoscopy Early Colonoscopy
Hide Arm/Group Description

Performance of prepared colonoscopy between 24 and 96 h after arrival

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

Performance of prepared colonoscopy within 24 h of arrival

Early colonoscopy: Performance of prepared colonoscopy within 24 h of arrival

Period Title: Overall Study
Started 81 81
Completed 80 79
Not Completed 1 2
Arm/Group Title Early Colonoscopy Elective Colonoscopy Total
Hide Arm/Group Description

Performance of prepared colonoscopy within 24 h of arrival

Early colonoscopy: Performance of prepared colonoscopy within 24 h of arrival

Performance of prepared colonoscopy between 24 and 96 h after arrival

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

Total of all reporting groups
Overall Number of Baseline Participants 79 80 159
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 79 participants 80 participants 159 participants
68.8  (12.8) 71.9  (12.3) 70.3  (12.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants 80 participants 159 participants
Female
27
  34.2%
26
  32.5%
53
  33.3%
Male
52
  65.8%
54
  67.5%
106
  66.7%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Asian Number Analyzed 79 participants 80 participants 159 participants
79
 100.0%
80
 100.0%
159
 100.0%
Body mass index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 79 participants 80 participants 159 participants
23.0  (3.3) 23.9  (4.1) 23.5  (3.7)
Previous lower GI bleeding  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants 80 participants 159 participants
28
  35.4%
30
  37.5%
58
  36.5%
Ischemic heart disease  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants 80 participants 159 participants
12
  15.2%
18
  22.5%
30
  18.9%
Chronic obstructive pulmonary disease  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants 80 participants 159 participants
3
   3.8%
0
   0.0%
3
   1.9%
Peptic ulcer  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants 80 participants 159 participants
6
   7.6%
2
   2.5%
8
   5.0%
Liver cirrhosis  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants 80 participants 159 participants
1
   1.3%
2
   2.5%
3
   1.9%
Diabetes mellitus  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants 80 participants 159 participants
11
  13.9%
16
  20.0%
27
  17.0%
Chronic heart failure  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants 80 participants 159 participants
4
   5.1%
5
   6.3%
9
   5.7%
Cerebrovascular disease  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants 80 participants 159 participants
11
  13.9%
15
  18.8%
26
  16.4%
Dementia  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants 80 participants 159 participants
0
   0.0%
2
   2.5%
2
   1.3%
Collagen disease  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants 80 participants 159 participants
4
   5.1%
5
   6.3%
9
   5.7%
Chronic kidney disease  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants 80 participants 159 participants
8
  10.1%
11
  13.8%
19
  11.9%
Leukemia  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants 80 participants 159 participants
0
   0.0%
1
   1.3%
1
   0.6%
Malignant lymphoma  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants 80 participants 159 participants
2
   2.5%
0
   0.0%
2
   1.3%
Solid cancer  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants 80 participants 159 participants
7
   8.9%
12
  15.0%
19
  11.9%
Low-dose aspirin  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants 80 participants 159 participants
16
  20.3%
22
  27.5%
38
  23.9%
Thienopyridine  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants 80 participants 159 participants
7
   8.9%
6
   7.5%
13
   8.2%
Cilostazol  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants 80 participants 159 participants
5
   6.3%
2
   2.5%
7
   4.4%
Other antiplatelet drugs  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants 80 participants 159 participants
5
   6.3%
3
   3.8%
8
   5.0%
Warfarin  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants 80 participants 159 participants
4
   5.1%
6
   7.5%
10
   6.3%
Direct oral anticoagulants  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants 80 participants 159 participants
3
   3.8%
7
   8.8%
10
   6.3%
NSAIDs  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants 80 participants 159 participants
14
  17.7%
16
  20.0%
30
  18.9%
Hemodynamic instability  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants 80 participants 159 participants
4
   5.1%
1
   1.3%
5
   3.1%
Hemoglobin  
Mean (Standard Deviation)
Unit of measure:  g/dL
Number Analyzed 79 participants 80 participants 159 participants
11.4  (2.7) 11.3  (2.3) 11.3  (2.5)
Upper GI endoscopy before colonoscopy  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants 80 participants 159 participants
2
   2.5%
1
   1.3%
3
   1.9%
Expert endoscopist  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants 80 participants 159 participants
48
  60.8%
48
  60.0%
96
  60.4%
Cecal insertion  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants 80 participants 159 participants
77
  97.5%
77
  96.3%
154
  96.9%
Cecal insertion time  
Mean (Standard Deviation)
Unit of measure:  Minutes
Number Analyzed 79 participants 80 participants 159 participants
9.6  (19.2) 9.0  (6.5) 9.3  (6.5)
Total procedure time  
Mean (Standard Deviation)
Unit of measure:  Minutes
Number Analyzed 79 participants 80 participants 159 participants
35.8  (19.2) 31.3  (15.1) 33.6  (17.4)
Bleeding source  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 79 participants 80 participants 159 participants
Diverticular bleeding (definite) 10 16 26
Diverticular bleeding (presumptive) 37 36 73
Colorectal cancer 3 2 5
Ischemic colitis 9 5 14
Infectious colitis 1 0 1
Radiation colitis 1 0 1
Colonic ulcer 0 2 2
Hemorrhoid 1 2 3
Other 7 4 11
Unknown 13 13 26
Upper GI bleeding 0 1 1
1.Primary Outcome
Title Stigmata of Recent Hemorrhage (SRH) Identification Rate
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Early Colonoscopy Elective Colonoscopy
Hide Arm/Group Description:

Performance of prepared colonoscopy within 24 h of arrival

Early colonoscopy: Performance of prepared colonoscopy within 24 h of arrival

Performance of prepared colonoscopy between 24 and 96 h after arrival

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

Overall Number of Participants Analyzed 79 80
Measure Type: Count of Participants
Unit of Measure: Participants
17
  21.5%
17
  21.3%
2.Secondary Outcome
Title Success Rate of Endoscopic Treatment; Number of Participants Achieving Hemostasis With Endoscopic Treatment
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Success rate of endoscopic treatment was defined as achievement of hemostasis (early for 15 patients and elective for 15 patients).
Arm/Group Title Early Colonoscopy Elective Colonoscopy
Hide Arm/Group Description:

Performance of prepared colonoscopy within 24 h of arrival

Early colonoscopy: Performance of prepared colonoscopy within 24 h of arrival

Performance of prepared colonoscopy between 24 and 96 h after arrival

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

Overall Number of Participants Analyzed 15 15
Measure Type: Count of Participants
Unit of Measure: Participants
14
  93.3%
15
 100.0%
3.Secondary Outcome
Title Need for Additional Endoscopic Examinations
Hide Description Additional endoscopic examinations will be defined as examinations to achieve hemostasis.
Time Frame 0-34 day
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Elective Colonoscopy Early Colonoscopy
Hide Arm/Group Description:

Performance of prepared colonoscopy between 24 and 96 h after arrival

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

Performance of prepared colonoscopy within 24 h of arrival

Early colonoscopy: Performance of prepared colonoscopy within 24 h of arrival

Overall Number of Participants Analyzed 79 80
Measure Type: Count of Participants
Unit of Measure: Participants
31
  39.2%
23
  28.7%
4.Secondary Outcome
Title Need for Interventional Radiology
Hide Description It will be defined as radiology intervention to achieve hemostasis.
Time Frame 0-34 day
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Early Colonoscopy Elective Colonoscopy
Hide Arm/Group Description:

Performance of prepared colonoscopy within 24 h of arrival

Early colonoscopy: Performance of prepared colonoscopy within 24 h of arrival

Performance of prepared colonoscopy between 24 and 96 h after arrival

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

Overall Number of Participants Analyzed 79 80
Measure Type: Count of Participants
Unit of Measure: Participants
1
   1.3%
0
   0.0%
5.Secondary Outcome
Title Need for Surgery
Hide Description It will be defined as surgery to achieve hemostasis.
Time Frame 0-34 day
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Early Colonoscopy Elective Colonoscopy
Hide Arm/Group Description:

Performance of prepared colonoscopy within 24 h of arrival

Early colonoscopy: Performance of prepared colonoscopy within 24 h of arrival

Performance of prepared colonoscopy between 24 and 96 h after arrival

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

Overall Number of Participants Analyzed 79 80
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
6.Secondary Outcome
Title Thirty-day Rebleeding Rates
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Early Colonoscopy Elective Colonoscopy
Hide Arm/Group Description:

Performance of prepared colonoscopy within 24 h of arrival

Early colonoscopy: Performance of prepared colonoscopy within 24 h of arrival

Performance of prepared colonoscopy between 24 and 96 h after arrival

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

Overall Number of Participants Analyzed 72 75
Measure Type: Count of Participants
Unit of Measure: Participants
11
  15.3%
5
   6.7%
7.Secondary Outcome
Title Need for Transfusion During Hospitalization
Hide Description It will be defined as the numbers of patients who will need transfusion.
Time Frame During hospitalization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Early Colonoscopy Elective Colonoscopy
Hide Arm/Group Description:

Performance of prepared colonoscopy within 24 h of arrival

Early colonoscopy: Performance of prepared colonoscopy within 24 h of arrival

Performance of prepared colonoscopy between 24 and 96 h after arrival

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

Overall Number of Participants Analyzed 79 80
Measure Type: Count of Participants
Unit of Measure: Participants
30
  38.0%
26
  32.5%
8.Secondary Outcome
Title Length of Stay
Hide Description It will be defined as length of stay to cure acute lower gastrointestinal bleeding.
Time Frame 0-34 day
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Early Colonoscopy Elective Colonoscopy
Hide Arm/Group Description:

Performance of prepared colonoscopy within 24 h of arrival

Early colonoscopy: Performance of prepared colonoscopy within 24 h of arrival

Performance of prepared colonoscopy between 24 and 96 h after arrival

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

Overall Number of Participants Analyzed 79 80
Mean (Standard Deviation)
Unit of Measure: days
7.1  (5.7) 7.6  (6.0)
9.Secondary Outcome
Title Number of Participants With Thirty-day Thrombosis Events
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Early Colonoscopy Elective Colonoscopy
Hide Arm/Group Description:

Performance of prepared colonoscopy within 24 h of arrival

Early colonoscopy: Performance of prepared colonoscopy within 24 h of arrival

Performance of prepared colonoscopy between 24 and 96 h after arrival

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

Overall Number of Participants Analyzed 72 75
Measure Type: Count of Participants
Unit of Measure: Participants
1
   1.4%
0
   0.0%
10.Secondary Outcome
Title Number of Participants With Thirty-day Death Events
Hide Description Number of Participants with Thirty-day death Events from enrollment
Time Frame 30 day
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Early Colonoscopy Elective Colonoscopy
Hide Arm/Group Description:

Performance of prepared colonoscopy within 24 h of arrival

Early colonoscopy: Performance of prepared colonoscopy within 24 h of arrival

Performance of prepared colonoscopy between 24 and 96 h after arrival

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

Overall Number of Participants Analyzed 79 80
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
11.Secondary Outcome
Title Number of Participants With Preparation-related Adverse Events
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Early Colonoscopy Elective Colonoscopy
Hide Arm/Group Description:

Performance of prepared colonoscopy within 24 h of arrival

Early colonoscopy: Performance of prepared colonoscopy within 24 h of arrival

Performance of prepared colonoscopy between 24 and 96 h after arrival

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

Overall Number of Participants Analyzed 79 80
Measure Type: Count of Participants
Unit of Measure: Participants
36
  45.6%
28
  35.0%
12.Secondary Outcome
Title Number of Participants With Colonoscopy-related Adverse Events
Hide Description Colonoscopy-related adverse events will include hemorrhagic shock, and perforation.
Time Frame 0-4 day
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Early Colonoscopy Elective Colonoscopy
Hide Arm/Group Description:

Performance of prepared colonoscopy within 24 h of arrival

Early colonoscopy: Performance of prepared colonoscopy within 24 h of arrival

Performance of prepared colonoscopy between 24 and 96 h after arrival

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

Overall Number of Participants Analyzed 79 80
Measure Type: Count of Participants
Unit of Measure: Participants
1
   1.3%
0
   0.0%
Time Frame 30 day
Adverse Event Reporting Description Data will be entered into a web-based EDC system by trial investigators or site investigators.
 
Arm/Group Title Early Colonoscopy Elective Colonoscopy
Hide Arm/Group Description

Performance of prepared colonoscopy within 24 h of arrival

Early colonoscopy: Performance of prepared colonoscopy within 24 h of arrival

Performance of prepared colonoscopy between 24 and 96 h after arrival

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

All-Cause Mortality
Early Colonoscopy Elective Colonoscopy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/79 (0.00%)      0/80 (0.00%)    
Hide Serious Adverse Events
Early Colonoscopy Elective Colonoscopy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/79 (2.53%)      0/80 (0.00%)    
Cardiac disorders     
Acute myocardial infarction  1  1/79 (1.27%)  1 0/80 (0.00%) 
Infections and infestations     
Bacterial cellulitis  1  1/79 (1.27%)  1 0/80 (0.00%) 
1
Term from vocabulary, MedDRA 22.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Early Colonoscopy Elective Colonoscopy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/79 (11.39%)      8/80 (10.00%)    
Gastrointestinal disorders     
Abdominal bloating  1  0/79 (0.00%)  1/80 (1.25%) 
General disorders     
Hypoxemia  1  0/79 (0.00%)  1/80 (1.25%) 
Infections and infestations     
Upper respiratory inflammation  1  1/79 (1.27%)  0/80 (0.00%) 
Pyrexia  1  2/79 (2.53%)  2/80 (2.50%) 
Metabolism and nutrition disorders     
Hypoglycemia  1  0/79 (0.00%)  1/80 (1.25%) 
Musculoskeletal and connective tissue disorders     
Pseudogout  1  1/79 (1.27%)  0/80 (0.00%) 
Arthritis pain  1  0/79 (0.00%)  1/80 (1.25%) 
Nervous system disorders     
Vagal reflex  1  1/79 (1.27%)  2/80 (2.50%) 
Headache  1  1/79 (1.27%)  0/80 (0.00%) 
Renal and urinary disorders     
Acute prostatitis  1  1/79 (1.27%)  0/80 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Oropharyngeal pain  1  1/79 (1.27%)  0/80 (0.00%) 
Skin and subcutaneous tissue disorders     
Rash  1  1/79 (1.27%)  0/80 (0.00%) 
1
Term from vocabulary, MedDRA 22.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Ryota Niikura
Organization: Tokyo University
Phone: +81-3-3815-5411
EMail: niikura-dky@umin.ac.jp
Layout table for additonal information
Responsible Party: Atsuo Yamada, Tokyo University
ClinicalTrials.gov Identifier: NCT03098173    
Other Study ID Numbers: P2015034-11Y
UMIN000021129 ( Other Identifier: University hospital Medical Information Network )
First Submitted: March 26, 2017
First Posted: March 31, 2017
Results First Submitted: September 26, 2019
Results First Posted: November 8, 2019
Last Update Posted: November 8, 2019