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A randomized controlled trial which aim at establishment of standard diagnosis and treatment for colonic diverticular bleeding

A randomized controlled trial which aim at establishment of standard diagnosis and treatment for colonic diverticular bleeding - A randomized controlled trial for standard diagnosis and treatment for colonic diverticular bleeding (eCT-DivBleed)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000026865
Enrollment
240
Registered
2017-04-10
Start date
2017-04-10
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

Colonic diverticular bleeding

Interventions

Urgent colonoscopy with a prior contrast-enhanced CT examination Urgent colonoscopy alone

Sponsors

National Hospital Organization Tokyo Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients who visited the study institution with hematochezia without accompanying abdominal pain within 24 hours after the last hematochezia, and whose colon diverticula were confirmed by non-contrast-enhanced CT examinations. (*Confirmation by a non-contrast-enhanced CT examination is not required, if existence of diverticula can be confirmed by a past image examination.) 2) 20-84 years old patients at time of acquisition of informed consent. 3) Patients who provided written consents for this study by themselves.

Exclusion criteria

Exclusion criteria: 1) Patients with hemorrhagic shock accompanying severe disturbance of consciousness at the time of visit. 2) Patients who do not improve from hemorrhagic shock even after infusion or transfusion. 3) Patients with confirmed melena. 4) Patients who have renal insufficiency and are determined to be inappropriate for use of contrast medium. 5) Patients taking antidiabetes drug of biguanide type. 6) Patients who are diagnosed as inflammatory bowel disease. 7) Patients with suspected hemorrhoidal bleeding. 8) Patients with performance status of grade2 or more. 9) Patients with contrast medium allergies. 10) Patients who are pregnant, or who are possibly pregnant. 11) Patients who have participated in this study in the past. 12) Patients who the principal investigator or other investigators decided not suitable for participation in this study.

Design outcomes

Primary

MeasureTime frame
Identification rate of colonic diverticular bleeding points.

Secondary

MeasureTime frame
Success rate of endoscopic hemostasis, time from last hematochezia to hemostasis, hemostatic rate classified by time from last hematochezia to colonoscopy, completion rate of colonoscopy, observed rate of extravasation of contrast medium on CT, hospitalization period, re-bleeding rate, additional colonoscopy rate and consequential hemostasis rate, rate of interventional radiology treatment required and consequential hemostasis rate, additional surgery rate and consequential hemostasis rate, incidence rate of adverse event, final diagnosis for cause of hematochezia.

Countries

Japan

Contacts

Public ContactToshio Uraoka

National Hospital Organization Tokyo Medical Center Department of Gastroenterolog

turaoka@ntmc-hosp.jp03-3411-0111

Outcome results

None listed

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