Comparing Early Versus Elective Colonoscopy

Tokyo University

Status: Completed

Conditions: Acute Lower Gastrointestinal Bleeding

Treatments: Procedure: Early colonoscopy; Procedure: Elective colonoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT03098173

UMIN000021129 (Other Identifier)

P2015034-11Y

Details and patient eligibility

About

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.

Full description

All patients will receive early colonoscopy or elective colonoscopy, but they do so by different timing.

Early colonoscopy will be performed within 24 h of the initial visit. Elective colonoscopy will be performed between 24 and 96 h after the initial visit.

Enrollment: 162 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Males or females aged ≥ 20 years, presenting with moderate-to-severe hematochezia or melena within 24 h of arrival, defined as (i) more than three occurrences of hematochezia within 8 h, (ii) hemorrhagic shock, or (iii) requiring transfusion.
2. Provision of signed and dated informed consent form.
3. Stated willingness to comply with all study procedures and availability for the duration of the study.

Exclusion criteria

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Patients with hematemesis, black vomiting, or melena.
2. Patients with upper gastrointestinal bleeding, diagnosed by nasogastric tube or upper endoscopy.
3. Patients who have impossible consumed the oral bowel preparation solution.
4. Patients who have undergone computed tomography.
5. Patients who have been diagnosed with peptic ulcer diseases within the previous 10 days.
6. Ulcerative colitis or Crohn's disease patients.
7. Patients who have undergone abdominal surgery within the previous 10 days.
8. Patients who have undergone polypectomy, endoscopic mucosal resection, or endoscopic submucosal dissection of the lower gastrointestinal tract within the previous 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 have undergone 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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162 participants in 2 patient groups

Early colonoscopy

Experimental group

Description:

Performance of prepared colonoscopy within 24 h of arrival

Treatment:

Procedure: Early colonoscopy

Elective colonoscopy

Active Comparator group

Description:

Performance of prepared colonoscopy between 24 and 96 h after arrival

Treatment:

Procedure: Elective colonoscopy