Trial Outcomes & Findings for Comparing Early Versus Elective Colonoscopy (NCT 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

Target enrollment

162 participants

Primary outcome timeframe

0-4 day

Results posted on

2019-11-08

Participant Flow

Participant milestones

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

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=5 Participants	71.9 years STANDARD_DEVIATION 12.3 • n=7 Participants	70.3 years STANDARD_DEVIATION 12.6 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants	26 Participants n=7 Participants	53 Participants n=5 Participants
Sex: Female, Male Male	52 Participants n=5 Participants	54 Participants n=7 Participants	106 Participants n=5 Participants
Race/Ethnicity, Customized Asian	79 Participants n=5 Participants	80 Participants n=7 Participants	159 Participants n=5 Participants
Body mass index	23.0 kg/m^2 STANDARD_DEVIATION 3.3 • n=5 Participants	23.9 kg/m^2 STANDARD_DEVIATION 4.1 • n=7 Participants	23.5 kg/m^2 STANDARD_DEVIATION 3.7 • n=5 Participants
Previous lower GI bleeding	28 Participants n=5 Participants	30 Participants n=7 Participants	58 Participants n=5 Participants
Ischemic heart disease	12 Participants n=5 Participants	18 Participants n=7 Participants	30 Participants n=5 Participants
Chronic obstructive pulmonary disease	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Peptic ulcer	6 Participants n=5 Participants	2 Participants n=7 Participants	8 Participants n=5 Participants
Liver cirrhosis	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Diabetes mellitus	11 Participants n=5 Participants	16 Participants n=7 Participants	27 Participants n=5 Participants
Chronic heart failure	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Cerebrovascular disease	11 Participants n=5 Participants	15 Participants n=7 Participants	26 Participants n=5 Participants
Dementia	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Collagen disease	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Chronic kidney disease	8 Participants n=5 Participants	11 Participants n=7 Participants	19 Participants n=5 Participants
Leukemia	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Malignant lymphoma	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Solid cancer	7 Participants n=5 Participants	12 Participants n=7 Participants	19 Participants n=5 Participants
Low-dose aspirin	16 Participants n=5 Participants	22 Participants n=7 Participants	38 Participants n=5 Participants
Thienopyridine	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Cilostazol	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Other antiplatelet drugs	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Warfarin	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Direct oral anticoagulants	3 Participants n=5 Participants	7 Participants n=7 Participants	10 Participants n=5 Participants
NSAIDs	14 Participants n=5 Participants	16 Participants n=7 Participants	30 Participants n=5 Participants
Hemodynamic instability	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Hemoglobin	11.4 g/dL STANDARD_DEVIATION 2.7 • n=5 Participants	11.3 g/dL STANDARD_DEVIATION 2.3 • n=7 Participants	11.3 g/dL STANDARD_DEVIATION 2.5 • n=5 Participants
Upper GI endoscopy before colonoscopy	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Expert endoscopist	48 Participants n=5 Participants	48 Participants n=7 Participants	96 Participants n=5 Participants
Cecal insertion	77 Participants n=5 Participants	77 Participants n=7 Participants	154 Participants n=5 Participants
Cecal insertion time	9.6 minutes STANDARD_DEVIATION 19.2 • n=5 Participants	9.0 minutes STANDARD_DEVIATION 6.5 • n=7 Participants	9.3 minutes STANDARD_DEVIATION 6.5 • n=5 Participants
Total procedure time	35.8 minutes STANDARD_DEVIATION 19.2 • n=5 Participants	31.3 minutes STANDARD_DEVIATION 15.1 • n=7 Participants	33.6 minutes STANDARD_DEVIATION 17.4 • n=5 Participants
Bleeding source Diverticular bleeding (definite)	10 participants n=5 Participants	16 participants n=7 Participants	26 participants n=5 Participants
Bleeding source Diverticular bleeding (presumptive)	37 participants n=5 Participants	36 participants n=7 Participants	73 participants n=5 Participants
Bleeding source Colorectal cancer	3 participants n=5 Participants	2 participants n=7 Participants	5 participants n=5 Participants
Bleeding source Ischemic colitis	9 participants n=5 Participants	5 participants n=7 Participants	14 participants n=5 Participants
Bleeding source Infectious colitis	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Bleeding source Radiation colitis	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Bleeding source Colonic ulcer	0 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants
Bleeding source Hemorrhoid	1 participants n=5 Participants	2 participants n=7 Participants	3 participants n=5 Participants
Bleeding source Other	7 participants n=5 Participants	4 participants n=7 Participants	11 participants n=5 Participants
Bleeding source Unknown	13 participants n=5 Participants	13 participants n=7 Participants	26 participants n=5 Participants
Bleeding source Upper GI bleeding	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants

PRIMARY outcome

Timeframe: 0-4 day

Population: 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

Outcome measures

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 day

Population: 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

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 day

Additional endoscopic examinations will be defined as examinations to achieve hemostasis.

Outcome measures

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 day

It will be defined as radiology intervention to achieve hemostasis.

Outcome measures

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 day

It will be defined as surgery to achieve hemostasis.

Outcome measures

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 day

Population: 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

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 hospitalization

It will be defined as the numbers of patients who will need transfusion.

Outcome measures

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 day

It will be defined as length of stay to cure acute lower gastrointestinal bleeding.

Outcome measures

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 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.

Outcome measures

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 day

Number of Participants with Thirty-day death Events from enrollment

Outcome measures

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 day

Preparation-related adverse events will include nausea, vomiting, abdominal pain, volume overload, aspiration pneumonia, hemorrhagic shock, exacerbation bleeding, and ileus

Outcome measures

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 day

Colonoscopy-related adverse events will include hemorrhagic shock, and perforation.

Outcome measures

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

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

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

Dr. Ryota Niikura

Tokyo University

Phone: +81-3-3815-5411

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place