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Comparing Early Versus Elective Colonoscopy
NA trial testing Early colonoscopy in Acute Lower Gastrointestinal Bleeding in 162 participants. Completed in 4 January 2019.
| Lead sponsor | Tokyo University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 162 |
| Start date | 29 January 2016 |
| Primary completion | 24 August 2018 |
| Estimated completion | 4 January 2019 |
| Sites | 15 locations across Japan |
Tokyo University
20 and older, any sex, with Acute Lower Gastrointestinal Bleeding. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Early Colonoscopy | 17 | |
| Elective Colonoscopy | 17 |
Success rate will be defined as the number achieving hemostasis per total number of attempts at endoscopic hemostasis during colonoscopy examination.
| Group | Value | 95% CI |
|---|---|---|
| Early Colonoscopy | 14 | |
| Elective Colonoscopy | 15 |
Additional endoscopic examinations will be defined as examinations to achieve hemostasis.
| Group | Value | 95% CI |
|---|---|---|
| Elective Colonoscopy | 31 | |
| Early Colonoscopy | 23 |
It will be defined as radiology intervention to achieve hemostasis.
| Group | Value | 95% CI |
|---|---|---|
| Early Colonoscopy | 1 | |
| Elective Colonoscopy | 0 |
It will be defined as surgery to achieve hemostasis.
| Group | Value | 95% CI |
|---|---|---|
| Early Colonoscopy | 0 | |
| Elective Colonoscopy | 0 |
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 peri
| Group | Value | 95% CI |
|---|---|---|
| Early Colonoscopy | 11 | |
| Elective Colonoscopy | 5 |
It will be defined as the numbers of patients who will need transfusion.
| Group | Value | 95% CI |
|---|---|---|
| Early Colonoscopy | 30 | |
| Elective Colonoscopy | 26 |
It will be defined as length of stay to cure acute lower gastrointestinal bleeding.
| Group | Value | 95% CI |
|---|---|---|
| Early Colonoscopy | 7.1 | ± 5.7 |
| Elective Colonoscopy | 7.6 | ± 6.0 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Early Colonoscopy | 1 | |
| Elective Colonoscopy | 0 |
Number of Participants with Thirty-day death Events from enrollment
| Group | Value | 95% CI |
|---|---|---|
| Early Colonoscopy | 0 | |
| Elective Colonoscopy | 0 |
Preparation-related adverse events will include nausea, vomiting, abdominal pain, volume overload, aspiration pneumonia, hemorrhagic shock, exacerbation bleeding, and ileus
| Group | Value | 95% CI |
|---|---|---|
| Early Colonoscopy | 36 | |
| Elective Colonoscopy | 28 |
Colonoscopy-related adverse events will include hemorrhagic shock, and perforation.
| Group | Value | 95% CI |
|---|---|---|
| Early Colonoscopy | 1 | |
| Elective Colonoscopy | 0 |
Time frame: 30 day. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Early Colonoscopy | Elective Colonoscopy |
|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | — | — |
| Bacterial cellulitis | Infections and infestations | — | — |
| Reaction | System | Early Colonoscopy | Elective Colonoscopy |
|---|---|---|---|
| Vagal reflex | Nervous system disorders | — | — |
| Pyrexia | Infections and infestations | — | — |
| Hypoxemia | General disorders | — | — |
| Rash | Skin and subcutaneous tissue disorders | — | — |
| Upper respiratory inflammation | Infections and infestations | — | — |
| Pseudogout | Musculoskeletal and connective tissue disorders | — | — |
| Acute prostatitis | Renal and urinary disorders | — | — |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | — | — |
| Hypoglycemia | Metabolism and nutrition disorders | — | — |
| Headache | Nervous system disorders | — | — |
| Arthritis pain | Musculoskeletal and connective tissue disorders | — | — |
| Abdominal bloating | Gastrointestinal disorders | — | — |
Most-reported serious reactions: Acute myocardial infarction, Bacterial cellulitis.
Data from ClinicalTrials.gov NCT03098173 adverse events section.
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.
2 peer-reviewed publications reference this trial (live from Europe PMC):
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Trials by the same sponsor.
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