Comparing Early Versus Elective Colonoscopy

Not Applicable

Completed

• Conditions: Acute Lower Gastrointestinal Bleeding
• Interventions: Procedure: Early colonoscopy; Procedure: Elective colonoscopy

• Registration Number: NCT03098173
• Lead Sponsor: Tokyo University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2016-01-29
• Study First Submitted: 2017-03-26
• Study First Submitted QC: 2017-03-27
• Study First Posted: 2017-03-31
• Primary Completion: 2018-08-24
• Study Completion: 2019-01-04
• Results First Submitted: 2019-09-26
• Status Verified: 2019-10
• Results First Submitted QC: 2019-10-21
• Last Update Submitted: 2019-10-21
• Results First Posted: 2019-11-08
• Last Update Posted: 2019-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 162

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early colonoscopy	Early colonoscopy	Performance of prepared colonoscopy within 24 h of arrival
Elective colonoscopy	Elective colonoscopy	Performance of prepared colonoscopy between 24 and 96 h after arrival

Primary Outcome Measures

Name	Time	Method
Stigmata of Recent Hemorrhage (SRH) Identification Rate	0-4 day	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.

Secondary Outcome Measures

Name	Time	Method
Need for Additional Endoscopic Examinations	0-34 day	Additional endoscopic examinations will be defined as examinations to achieve hemostasis.
Need for Surgery	0-34 day	It will be defined as surgery to achieve hemostasis.
Success Rate of Endoscopic Treatment; Number of Participants Achieving Hemostasis With Endoscopic Treatment	0-4 day	Success rate will be defined as the number achieving hemostasis per total number of attempts at endoscopic hemostasis during colonoscopy examination.
Need for Transfusion During Hospitalization	During hospitalization	It will be defined as the numbers of patients who will need transfusion.
Number of Participants With Colonoscopy-related Adverse Events	0-4 day	Colonoscopy-related adverse events will include hemorrhagic shock, and perforation.
Need for Interventional Radiology	0-34 day	It will be defined as radiology intervention to achieve hemostasis.
Number of Participants With Thirty-day Death Events	30 day	Number of Participants with Thirty-day death Events from enrollment
Number of Participants With Preparation-related Adverse Events	0-4 day	Preparation-related adverse events will include nausea, vomiting, abdominal pain, volume overload, aspiration pneumonia, hemorrhagic shock, exacerbation bleeding, and ileus
Thirty-day Rebleeding Rates	30 day	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.
Length of Stay	0-34 day	It will be defined as length of stay to cure acute lower gastrointestinal bleeding.
Number of Participants With Thirty-day Thrombosis Events	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.

Trial Locations

Locations (15)

Fukui prefectural hospital; 🇯🇵 Fukui-shi, Fukui, Japan

Otaru Ekisaikai Hospital; 🇯🇵 Otaru-shi, Hokkaido, Japan

Nagasaki Harbor Medical Center City Hospital; 🇯🇵 Nagasaki-shi, Nagasaki, Japan

Ishikawa prefectural central hospital; 🇯🇵 Kanazawa city, Ishikawa, Japan

Hirosaki University Hospital; 🇯🇵 Hirosaki-shi, Aomori, Japan

National Hospital Organization Hakodate Hospital; 🇯🇵 Hakodate-shi, Hokkaido, Japan

Shuto General Hospital; 🇯🇵 Yanai-shi, Yamaguchi, Japan

National Center for Global Health and Medicine center hospital; 🇯🇵 Shinjuku-ku, Tokyo, Japan

Toyonaka Municipal Hospital; 🇯🇵 Toyonaka-shi, Osaka, Japan

National Center for Global Health and Medicine kohnodai hospital; 🇯🇵 Ichikawa-shi, Chiba, Japan

Tonan Hospital; 🇯🇵 Sapporo-shi, Hokkaido, Japan

Japan Community Healthcare Organization Osaka Hospital; 🇯🇵 Fukushima-shi, Osaka, Japan

St. Luke's International Hospital; 🇯🇵 Chuo-ku, Tokyo, Japan

Aichi Cancer Center Hospital; 🇯🇵 Nagoya-shi, Aichi, Japan

The University of Tokyo; 🇯🇵 Bunkyo-ku, Tokyo, Japan