Comparing Early Versus Elective Colonoscopy

Acute Lower Gastrointestinal Bleeding Clinical Trial

Official title:

A Multi-center, Randomized Controlled Trial Comparing Early Versus Elective Colonoscopy in Outpatients With Acute Lower Gastrointestinal Bleeding

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03098173
• Other study ID #: P2015034-11Y
• Secondary ID: UMIN000021129
• Status: Completed
• Phase: N/A
• Start date: January 29, 2016
• Est. completion date: January 4, 2019

Study information

• Verified date: October 2019
• Source: Tokyo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: January 4, 2019
• Est. primary completion date: August 24, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Lower Gastrointestinal Bleeding
• Gastrointestinal Hemorrhage
• Hemorrhage

Intervention

Procedure:
• Early colonoscopy
Performance of prepared colonoscopy within 24 h of arrival
• Elective colonoscopy
Performance of prepared colonoscopy between 24 and 96 h after arrival

Locations

Country	Name	City	State
Japan	The University of Tokyo	Bunkyo-ku	Tokyo
Japan	St. Luke's International Hospital	Chuo-ku	Tokyo
Japan	Fukui prefectural hospital	Fukui-shi	Fukui
Japan	Japan Community Healthcare Organization Osaka Hospital	Fukushima-shi	Osaka
Japan	National Hospital Organization Hakodate Hospital	Hakodate-shi	Hokkaido
Japan	Hirosaki University Hospital	Hirosaki-shi	Aomori
Japan	National Center for Global Health and Medicine kohnodai hospital	Ichikawa-shi	Chiba
Japan	Ishikawa prefectural central hospital	Kanazawa city	Ishikawa
Japan	Nagasaki Harbor Medical Center City Hospital	Nagasaki-shi	Nagasaki
Japan	Aichi Cancer Center Hospital	Nagoya-shi	Aichi
Japan	Otaru Ekisaikai Hospital	Otaru-shi	Hokkaido
Japan	Tonan Hospital	Sapporo-shi	Hokkaido
Japan	National Center for Global Health and Medicine center hospital	Shinjuku-ku	Tokyo
Japan	Toyonaka Municipal Hospital	Toyonaka-shi	Osaka
Japan	Shuto General Hospital	Yanai-shi	Yamaguchi

Sponsors (1)

Lead Sponsor	Collaborator
Tokyo University

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Niikura R, Nagata N, Doyama H, Ota R, Ishii N, Mabe K, Nishida T, Hikichi T, Sumiyama K, Nishikawa J, Uraoka T, Kiyotoki S, Fujishiro M, Koike K. Current state of practice for colonic diverticular bleeding in 37 hospitals in Japan: A multicenter questionnaire study. World J Gastrointest Endosc. 2016 Dec 16;8(20):785-794. doi: 10.4253/wjge.v8.i20.785. — View Citation

Outcome

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

External Links

•   Early versus Elective Colonoscopy Trial