Comparing Early Versus Elective Colonoscopy

• ClinicalTrials.gov Identifier: NCT03098173
• Recruitment Status: Completed
• First Posted: March 31, 2017
• Results First Posted: November 8, 2019
• Last Update Posted: November 8, 2019
• Sponsor: Tokyo University
• Information provided by (Responsible Party): Atsuo Yamada, Tokyo University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Acute Lower Gastrointestinal Bleeding	Procedure: Early colonoscopy; Procedure: Elective colonoscopy	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 162 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Parallel, randomized, superiority trial
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Multi-center, Randomized Controlled Trial Comparing Early Versus Elective Colonoscopy in Outpatients With Acute Lower Gastrointestinal Bleeding
• Actual Study Start Date: January 29, 2016
• Actual Primary Completion Date: August 24, 2018
• Actual Study Completion Date: January 4, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Early colonoscopy; Performance of prepared colonoscopy within 24 h of arrival	Procedure: Early colonoscopy; Performance of prepared colonoscopy within 24 h of arrival
Active Comparator: Elective colonoscopy; Performance of prepared colonoscopy between 24 and 96 h after arrival	Procedure: Elective colonoscopy; Performance of prepared colonoscopy between 24 and 96 h after arrival

Outcome Measures

Primary Outcome Measures :

1. Stigmata of Recent Hemorrhage (SRH) Identification Rate [ Time Frame: 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 :

1. Success Rate of Endoscopic Treatment; Number of Participants Achieving Hemostasis With Endoscopic Treatment [ Time Frame: 0-4 day ]
   Success rate will be defined as the number achieving hemostasis per total number of attempts at endoscopic hemostasis during colonoscopy examination.
2. Need for Additional Endoscopic Examinations [ Time Frame: 0-34 day ]
   Additional endoscopic examinations will be defined as examinations to achieve hemostasis.
3. Need for Interventional Radiology [ Time Frame: 0-34 day ]
   It will be defined as radiology intervention to achieve hemostasis.
4. Need for Surgery [ Time Frame: 0-34 day ]
   It will be defined as surgery to achieve hemostasis.
5. Thirty-day Rebleeding Rates [ Time Frame: 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.

6. Need for Transfusion During Hospitalization [ Time Frame: During hospitalization ]
   It will be defined as the numbers of patients who will need transfusion.
7. Length of Stay [ Time Frame: 0-34 day ]
   It will be defined as length of stay to cure acute lower gastrointestinal bleeding.
8. Number of Participants With Thirty-day Thrombosis Events [ Time Frame: 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.
9. Number of Participants With Thirty-day Death Events [ Time Frame: 30 day ]
   Number of Participants with Thirty-day death Events from enrollment
10. Number of Participants With Preparation-related Adverse Events [ Time Frame: 0-4 day ]
    Preparation-related adverse events will include nausea, vomiting, abdominal pain, volume overload, aspiration pneumonia, hemorrhagic shock, exacerbation bleeding, and ileus
11. Number of Participants With Colonoscopy-related Adverse Events [ Time Frame: 0-4 day ]
    Colonoscopy-related adverse events will include hemorrhagic shock, and perforation.

Eligibility Criteria

• Ages Eligible for Study: 20 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

Japan

Aichi Cancer Center Hospital

Nagoya-shi, Aichi, Japan

Hirosaki University Hospital

Hirosaki-shi, Aomori, Japan

National Center for Global Health and Medicine kohnodai hospital

Ichikawa-shi, Chiba, Japan

Fukui prefectural hospital

Fukui-shi, Fukui, Japan

National Hospital Organization Hakodate Hospital

Hakodate-shi, Hokkaido, Japan

Otaru Ekisaikai Hospital

Otaru-shi, Hokkaido, Japan

Tonan Hospital

Sapporo-shi, Hokkaido, Japan

Ishikawa prefectural central hospital

Kanazawa city, Ishikawa, Japan

Nagasaki Harbor Medical Center City Hospital

Nagasaki-shi, Nagasaki, Japan

Japan Community Healthcare Organization Osaka Hospital

Fukushima-shi, Osaka, Japan

Toyonaka Municipal Hospital

Toyonaka-shi, Osaka, Japan

The University of Tokyo

Bunkyo-ku, Tokyo, Japan

St. Luke's International Hospital

Chuo-ku, Tokyo, Japan

National Center for Global Health and Medicine center hospital

Shinjuku-ku, Tokyo, Japan

Shuto General Hospital

Yanai-shi, Yamaguchi, Japan

Sponsors and Collaborators

Tokyo University

Investigators

• Study Director: Atsuo Yamada, MD; Tokyo University

  Study Documents (Full-Text)

Documents provided by Atsuo Yamada, Tokyo University:

Study Protocol and Statistical Analysis Plan  [PDF] January 9, 2018

More Information

Additional Information:

Early versus Elective Colonoscopy Trial 

Study Data/Documents: Study Protocol 

Publications:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Niikura R, Nagata N, Yamada A, Honda T, Hasatani K, Ishii N, Shiratori Y, Doyama H, Nishida T, Sumiyoshi T, Fujita T, Kiyotoki S, Yada T, Yamamoto K, Shinozaki T, Takata M, Mikami T, Mabe K, Hara K, Fujishiro M, Koike K. Efficacy and Safety of Early vs Elective Colonoscopy for Acute Lower Gastrointestinal Bleeding. Gastroenterology. 2020 Jan;158(1):168-175.e6. doi: 10.1053/j.gastro.2019.09.010. Epub 2019 Sep 26.

Niikura R, Nagata N, Yamada A, Doyama H, Shiratori Y, Nishida T, Kiyotoki S, Yada T, Fujita T, Sumiyoshi T, Hasatani K, Mikami T, Honda T, Mabe K, Hara K, Yamamoto K, Takeda M, Takata M, Tanaka M, Shinozaki T, Fujishiro M, Koike K. A multicenter, randomized controlled trial comparing the identification rate of stigmata of recent hemorrhage and rebleeding rate between early and elective colonoscopy in outpatient-onset acute lower gastrointestinal bleeding: study protocol for a randomized controlled trial. Trials. 2018 Apr 3;19(1):214. doi: 10.1186/s13063-018-2558-y.

• Responsible Party: Atsuo Yamada, Department of Gastroenterology, Tokyo University
• ClinicalTrials.gov Identifier: NCT03098173
• Other Study ID Numbers: P2015034-11Y; UMIN000021129 ( Other Identifier: University hospital Medical Information Network )
• First Posted: March 31, 2017
• Results First Posted: November 8, 2019
• Last Update Posted: November 8, 2019
• Last Verified: October 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Atsuo Yamada, Tokyo University:

Early colonoscopy; Stigmata of recent hemorrhage; Rebleeding

Additional relevant MeSH terms:

Gastrointestinal Hemorrhage; Hemorrhage; Pathologic Processes; Gastrointestinal Diseases; Digestive System Diseases