Trial Outcomes & Findings for Comparing Early Versus Elective Colonoscopy (NCT NCT03098173)
NCT ID: NCT03098173
Last Updated: 2019-11-08
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
162 participants
Primary outcome timeframe
0-4 day
Results posted on
2019-11-08
Participant Flow
Participant milestones
| Measure |
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
|
Early Colonoscopy
Performance of prepared colonoscopy within 24 h of arrival
Early colonoscopy: Performance of prepared colonoscopy within 24 h of arrival
|
|---|---|---|
|
Overall Study
STARTED
|
81
|
81
|
|
Overall Study
COMPLETED
|
80
|
79
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparing Early Versus Elective Colonoscopy
Baseline characteristics by cohort
| Measure |
Early Colonoscopy
n=79 Participants
Performance of prepared colonoscopy within 24 h of arrival
Early colonoscopy: Performance of prepared colonoscopy within 24 h of arrival
|
Elective Colonoscopy
n=80 Participants
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
n=159 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.8 years
STANDARD_DEVIATION 12.8 • n=99 Participants
|
71.9 years
STANDARD_DEVIATION 12.3 • n=107 Participants
|
70.3 years
STANDARD_DEVIATION 12.6 • n=206 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
53 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=99 Participants
|
54 Participants
n=107 Participants
|
106 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
79 Participants
n=99 Participants
|
80 Participants
n=107 Participants
|
159 Participants
n=206 Participants
|
|
Body mass index
|
23.0 kg/m^2
STANDARD_DEVIATION 3.3 • n=99 Participants
|
23.9 kg/m^2
STANDARD_DEVIATION 4.1 • n=107 Participants
|
23.5 kg/m^2
STANDARD_DEVIATION 3.7 • n=206 Participants
|
|
Previous lower GI bleeding
|
28 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
|
Ischemic heart disease
|
12 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Chronic obstructive pulmonary disease
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Peptic ulcer
|
6 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Liver cirrhosis
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Diabetes mellitus
|
11 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Chronic heart failure
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Cerebrovascular disease
|
11 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Dementia
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Collagen disease
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Chronic kidney disease
|
8 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Leukemia
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Malignant lymphoma
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Solid cancer
|
7 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Low-dose aspirin
|
16 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Thienopyridine
|
7 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Cilostazol
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Other antiplatelet drugs
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Warfarin
|
4 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Direct oral anticoagulants
|
3 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
NSAIDs
|
14 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Hemodynamic instability
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Hemoglobin
|
11.4 g/dL
STANDARD_DEVIATION 2.7 • n=99 Participants
|
11.3 g/dL
STANDARD_DEVIATION 2.3 • n=107 Participants
|
11.3 g/dL
STANDARD_DEVIATION 2.5 • n=206 Participants
|
|
Upper GI endoscopy before colonoscopy
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Expert endoscopist
|
48 Participants
n=99 Participants
|
48 Participants
n=107 Participants
|
96 Participants
n=206 Participants
|
|
Cecal insertion
|
77 Participants
n=99 Participants
|
77 Participants
n=107 Participants
|
154 Participants
n=206 Participants
|
|
Cecal insertion time
|
9.6 minutes
STANDARD_DEVIATION 19.2 • n=99 Participants
|
9.0 minutes
STANDARD_DEVIATION 6.5 • n=107 Participants
|
9.3 minutes
STANDARD_DEVIATION 6.5 • n=206 Participants
|
|
Total procedure time
|
35.8 minutes
STANDARD_DEVIATION 19.2 • n=99 Participants
|
31.3 minutes
STANDARD_DEVIATION 15.1 • n=107 Participants
|
33.6 minutes
STANDARD_DEVIATION 17.4 • n=206 Participants
|
|
Bleeding source
Diverticular bleeding (definite)
|
10 participants
n=99 Participants
|
16 participants
n=107 Participants
|
26 participants
n=206 Participants
|
|
Bleeding source
Diverticular bleeding (presumptive)
|
37 participants
n=99 Participants
|
36 participants
n=107 Participants
|
73 participants
n=206 Participants
|
|
Bleeding source
Colorectal cancer
|
3 participants
n=99 Participants
|
2 participants
n=107 Participants
|
5 participants
n=206 Participants
|
|
Bleeding source
Ischemic colitis
|
9 participants
n=99 Participants
|
5 participants
n=107 Participants
|
14 participants
n=206 Participants
|
|
Bleeding source
Infectious colitis
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Bleeding source
Radiation colitis
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Bleeding source
Colonic ulcer
|
0 participants
n=99 Participants
|
2 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Bleeding source
Hemorrhoid
|
1 participants
n=99 Participants
|
2 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Bleeding source
Other
|
7 participants
n=99 Participants
|
4 participants
n=107 Participants
|
11 participants
n=206 Participants
|
|
Bleeding source
Unknown
|
13 participants
n=99 Participants
|
13 participants
n=107 Participants
|
26 participants
n=206 Participants
|
|
Bleeding source
Upper GI bleeding
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 0-4 dayPopulation: 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
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.
Outcome measures
| Measure |
Early Colonoscopy
n=79 Participants
Performance of prepared colonoscopy within 24 h of arrival
Early colonoscopy: Performance of prepared colonoscopy within 24 h of arrival
|
Elective Colonoscopy
n=80 Participants
Performance of prepared colonoscopy between 24 and 96 h after arrival
Elective colonoscopy: Performance of prepared colonoscopy between 24 and 96 h after arrival
|
|---|---|---|
|
Stigmata of Recent Hemorrhage (SRH) Identification Rate
|
17 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: 0-4 dayPopulation: Success rate of endoscopic treatment was defined as achievement of hemostasis (early for 15 patients and elective for 15 patients).
Success rate will be defined as the number achieving hemostasis per total number of attempts at endoscopic hemostasis during colonoscopy examination.
Outcome measures
| Measure |
Early Colonoscopy
n=15 Participants
Performance of prepared colonoscopy within 24 h of arrival
Early colonoscopy: Performance of prepared colonoscopy within 24 h of arrival
|
Elective Colonoscopy
n=15 Participants
Performance of prepared colonoscopy between 24 and 96 h after arrival
Elective colonoscopy: Performance of prepared colonoscopy between 24 and 96 h after arrival
|
|---|---|---|
|
Success Rate of Endoscopic Treatment; Number of Participants Achieving Hemostasis With Endoscopic Treatment
|
14 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: 0-34 dayAdditional endoscopic examinations will be defined as examinations to achieve hemostasis.
Outcome measures
| Measure |
Early Colonoscopy
n=79 Participants
Performance of prepared colonoscopy within 24 h of arrival
Early colonoscopy: Performance of prepared colonoscopy within 24 h of arrival
|
Elective Colonoscopy
n=80 Participants
Performance of prepared colonoscopy between 24 and 96 h after arrival
Elective colonoscopy: Performance of prepared colonoscopy between 24 and 96 h after arrival
|
|---|---|---|
|
Need for Additional Endoscopic Examinations
|
31 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: 0-34 dayIt will be defined as radiology intervention to achieve hemostasis.
Outcome measures
| Measure |
Early Colonoscopy
n=79 Participants
Performance of prepared colonoscopy within 24 h of arrival
Early colonoscopy: Performance of prepared colonoscopy within 24 h of arrival
|
Elective Colonoscopy
n=80 Participants
Performance of prepared colonoscopy between 24 and 96 h after arrival
Elective colonoscopy: Performance of prepared colonoscopy between 24 and 96 h after arrival
|
|---|---|---|
|
Need for Interventional Radiology
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 0-34 dayIt will be defined as surgery to achieve hemostasis.
Outcome measures
| Measure |
Early Colonoscopy
n=79 Participants
Performance of prepared colonoscopy within 24 h of arrival
Early colonoscopy: Performance of prepared colonoscopy within 24 h of arrival
|
Elective Colonoscopy
n=80 Participants
Performance of prepared colonoscopy between 24 and 96 h after arrival
Elective colonoscopy: Performance of prepared colonoscopy between 24 and 96 h after arrival
|
|---|---|---|
|
Need for Surgery
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 30 dayPopulation: 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).
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.
Outcome measures
| Measure |
Early Colonoscopy
n=72 Participants
Performance of prepared colonoscopy within 24 h of arrival
Early colonoscopy: Performance of prepared colonoscopy within 24 h of arrival
|
Elective Colonoscopy
n=75 Participants
Performance of prepared colonoscopy between 24 and 96 h after arrival
Elective colonoscopy: Performance of prepared colonoscopy between 24 and 96 h after arrival
|
|---|---|---|
|
Thirty-day Rebleeding Rates
|
11 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: During hospitalizationIt will be defined as the numbers of patients who will need transfusion.
Outcome measures
| Measure |
Early Colonoscopy
n=79 Participants
Performance of prepared colonoscopy within 24 h of arrival
Early colonoscopy: Performance of prepared colonoscopy within 24 h of arrival
|
Elective Colonoscopy
n=80 Participants
Performance of prepared colonoscopy between 24 and 96 h after arrival
Elective colonoscopy: Performance of prepared colonoscopy between 24 and 96 h after arrival
|
|---|---|---|
|
Need for Transfusion During Hospitalization
|
30 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: 0-34 dayIt will be defined as length of stay to cure acute lower gastrointestinal bleeding.
Outcome measures
| Measure |
Early Colonoscopy
n=79 Participants
Performance of prepared colonoscopy within 24 h of arrival
Early colonoscopy: Performance of prepared colonoscopy within 24 h of arrival
|
Elective Colonoscopy
n=80 Participants
Performance of prepared colonoscopy between 24 and 96 h after arrival
Elective colonoscopy: Performance of prepared colonoscopy between 24 and 96 h after arrival
|
|---|---|---|
|
Length of Stay
|
7.1 days
Standard Deviation 5.7
|
7.6 days
Standard Deviation 6.0
|
SECONDARY outcome
Timeframe: 30 dayPopulation: 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).
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.
Outcome measures
| Measure |
Early Colonoscopy
n=72 Participants
Performance of prepared colonoscopy within 24 h of arrival
Early colonoscopy: Performance of prepared colonoscopy within 24 h of arrival
|
Elective Colonoscopy
n=75 Participants
Performance of prepared colonoscopy between 24 and 96 h after arrival
Elective colonoscopy: Performance of prepared colonoscopy between 24 and 96 h after arrival
|
|---|---|---|
|
Number of Participants With Thirty-day Thrombosis Events
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 30 dayNumber of Participants with Thirty-day death Events from enrollment
Outcome measures
| Measure |
Early Colonoscopy
n=79 Participants
Performance of prepared colonoscopy within 24 h of arrival
Early colonoscopy: Performance of prepared colonoscopy within 24 h of arrival
|
Elective Colonoscopy
n=80 Participants
Performance of prepared colonoscopy between 24 and 96 h after arrival
Elective colonoscopy: Performance of prepared colonoscopy between 24 and 96 h after arrival
|
|---|---|---|
|
Number of Participants With Thirty-day Death Events
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 0-4 dayPreparation-related adverse events will include nausea, vomiting, abdominal pain, volume overload, aspiration pneumonia, hemorrhagic shock, exacerbation bleeding, and ileus
Outcome measures
| Measure |
Early Colonoscopy
n=79 Participants
Performance of prepared colonoscopy within 24 h of arrival
Early colonoscopy: Performance of prepared colonoscopy within 24 h of arrival
|
Elective Colonoscopy
n=80 Participants
Performance of prepared colonoscopy between 24 and 96 h after arrival
Elective colonoscopy: Performance of prepared colonoscopy between 24 and 96 h after arrival
|
|---|---|---|
|
Number of Participants With Preparation-related Adverse Events
|
36 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: 0-4 dayColonoscopy-related adverse events will include hemorrhagic shock, and perforation.
Outcome measures
| Measure |
Early Colonoscopy
n=79 Participants
Performance of prepared colonoscopy within 24 h of arrival
Early colonoscopy: Performance of prepared colonoscopy within 24 h of arrival
|
Elective Colonoscopy
n=80 Participants
Performance of prepared colonoscopy between 24 and 96 h after arrival
Elective colonoscopy: Performance of prepared colonoscopy between 24 and 96 h after arrival
|
|---|---|---|
|
Number of Participants With Colonoscopy-related Adverse Events
|
1 Participants
|
0 Participants
|
Adverse Events
Early Colonoscopy
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
Elective Colonoscopy
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Early Colonoscopy
n=79 participants at risk
Performance of prepared colonoscopy within 24 h of arrival
Early colonoscopy: Performance of prepared colonoscopy within 24 h of arrival
|
Elective Colonoscopy
n=80 participants at risk
Performance of prepared colonoscopy between 24 and 96 h after arrival
Elective colonoscopy: Performance of prepared colonoscopy between 24 and 96 h after arrival
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
1.3%
1/79 • Number of events 1 • 30 day
Data will be entered into a web-based EDC system by trial investigators or site investigators.
|
0.00%
0/80 • 30 day
Data will be entered into a web-based EDC system by trial investigators or site investigators.
|
|
Infections and infestations
Bacterial cellulitis
|
1.3%
1/79 • Number of events 1 • 30 day
Data will be entered into a web-based EDC system by trial investigators or site investigators.
|
0.00%
0/80 • 30 day
Data will be entered into a web-based EDC system by trial investigators or site investigators.
|
Other adverse events
| Measure |
Early Colonoscopy
n=79 participants at risk
Performance of prepared colonoscopy within 24 h of arrival
Early colonoscopy: Performance of prepared colonoscopy within 24 h of arrival
|
Elective Colonoscopy
n=80 participants at risk
Performance of prepared colonoscopy between 24 and 96 h after arrival
Elective colonoscopy: Performance of prepared colonoscopy between 24 and 96 h after arrival
|
|---|---|---|
|
General disorders
Hypoxemia
|
0.00%
0/79 • 30 day
Data will be entered into a web-based EDC system by trial investigators or site investigators.
|
1.2%
1/80 • 30 day
Data will be entered into a web-based EDC system by trial investigators or site investigators.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.3%
1/79 • 30 day
Data will be entered into a web-based EDC system by trial investigators or site investigators.
|
0.00%
0/80 • 30 day
Data will be entered into a web-based EDC system by trial investigators or site investigators.
|
|
Infections and infestations
Upper respiratory inflammation
|
1.3%
1/79 • 30 day
Data will be entered into a web-based EDC system by trial investigators or site investigators.
|
0.00%
0/80 • 30 day
Data will be entered into a web-based EDC system by trial investigators or site investigators.
|
|
Musculoskeletal and connective tissue disorders
Pseudogout
|
1.3%
1/79 • 30 day
Data will be entered into a web-based EDC system by trial investigators or site investigators.
|
0.00%
0/80 • 30 day
Data will be entered into a web-based EDC system by trial investigators or site investigators.
|
|
Renal and urinary disorders
Acute prostatitis
|
1.3%
1/79 • 30 day
Data will be entered into a web-based EDC system by trial investigators or site investigators.
|
0.00%
0/80 • 30 day
Data will be entered into a web-based EDC system by trial investigators or site investigators.
|
|
Nervous system disorders
Vagal reflex
|
1.3%
1/79 • 30 day
Data will be entered into a web-based EDC system by trial investigators or site investigators.
|
2.5%
2/80 • 30 day
Data will be entered into a web-based EDC system by trial investigators or site investigators.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.3%
1/79 • 30 day
Data will be entered into a web-based EDC system by trial investigators or site investigators.
|
0.00%
0/80 • 30 day
Data will be entered into a web-based EDC system by trial investigators or site investigators.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/79 • 30 day
Data will be entered into a web-based EDC system by trial investigators or site investigators.
|
1.2%
1/80 • 30 day
Data will be entered into a web-based EDC system by trial investigators or site investigators.
|
|
Nervous system disorders
Headache
|
1.3%
1/79 • 30 day
Data will be entered into a web-based EDC system by trial investigators or site investigators.
|
0.00%
0/80 • 30 day
Data will be entered into a web-based EDC system by trial investigators or site investigators.
|
|
Infections and infestations
Pyrexia
|
2.5%
2/79 • 30 day
Data will be entered into a web-based EDC system by trial investigators or site investigators.
|
2.5%
2/80 • 30 day
Data will be entered into a web-based EDC system by trial investigators or site investigators.
|
|
Musculoskeletal and connective tissue disorders
Arthritis pain
|
0.00%
0/79 • 30 day
Data will be entered into a web-based EDC system by trial investigators or site investigators.
|
1.2%
1/80 • 30 day
Data will be entered into a web-based EDC system by trial investigators or site investigators.
|
|
Gastrointestinal disorders
Abdominal bloating
|
0.00%
0/79 • 30 day
Data will be entered into a web-based EDC system by trial investigators or site investigators.
|
1.2%
1/80 • 30 day
Data will be entered into a web-based EDC system by trial investigators or site investigators.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place