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A multi-center, randomized controlled trial comparing early versus elective colonoscopy in outpatients with acute lower gastrointestinal bleeding

A multi-center, randomized controlled trial comparing early versus elective colonoscopy in outpatients with acute lower gastrointestinal bleeding - Early colonoscopy trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000021129
Enrollment
162
Registered
2016-02-21
Start date
2016-07-13
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute lower gastrointestinal bleeding

Interventions

Early colonoscopy: performing prepared colonoscopy within 24 h on arrival. Elective colonoscopy: performing prepared colonoscopy between 24 and 96 h on arrival.

Sponsors

Graduate School of Medicine, The University of Tokyo
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Inclusion criteria 1.Adults aged>=20 years presenting moderate to severe hematochezia or melena within 24 h on arrival, defined as (i) more than 3 bloody bowel movements within 8 h; (ii) hemorrhagic shock; or (iii) requiring transfusion. 2.All patients were able to provide informed consent.

Exclusion criteria

Exclusion criteria: Exclusion criteria 1.Patients with hematemesis, black vomiting, or melena. 2.Upper gastrointestinal bleeding patients who diagnosed by nasogastric tube or upper endoscopy. 3.Patients who had impossible consumed the oral bowel preparation solution. 4.Patients who received computed tomography. 5.Patients who diagnosed peptic ulcer diseases within 10 days. 6.Ulcerative colitis, or Crohn diseases patients. 7.Patients who received abdominal surgery. 8.Patients who received polypectomy, endoscopic mucosal resection, or endoscopic submucosal dissection of the colon within 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 received 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.

Design outcomes

Primary

MeasureTime frame
Stigmata recent of hemorrhage rate in lower gastrointestinal tract

Secondary

MeasureTime frame
Success rate of endoscopic treatment, need for additional endoscopic examination, need for interventional radiology, need for surgery, 30 day rebleeding rates, length of stay, 30 day thrombosis events, 30 day mortality, preparation related adverse events (nausea, vomitting, abdominal pain, volume overload, aspiration pnumonia, hemorrhagic shock, exacerbation bleeding, and ileus), and colonoscopy related adverse events (hemorrhagic shock, and perforation).

Countries

Japan

Contacts

Public ContactRyota Niikua

Graduate School of Medicine, The University of Tokyo Department of Gastroenterology

rniikura@triton.ocn.ne.jp03-3815-5411

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026