Comparing Early Versus Elective Colonoscopy

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Lower Gastrointestinal Bleeding
• Intervention / Treatment: Procedure: Early colonoscopy; Procedure: 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 Type: Interventional
• Enrollment (Actual): 162
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

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

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Need for Additional Endoscopic Examinations	Additional endoscopic examinations will be defined as examinations to achieve hemostasis.	0-34 day
Need for Interventional Radiology	It will be defined as radiology intervention to achieve hemostasis.	0-34 day
Need for Surgery	It will be defined as surgery to achieve hemostasis.	0-34 day
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
Need for Transfusion During Hospitalization	It will be defined as the numbers of patients who will need transfusion.	During hospitalization
Length of Stay	It will be defined as length of stay to cure acute lower gastrointestinal bleeding.	0-34 day
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
Number of Participants With Thirty-day Death Events	Number of Participants with Thirty-day death Events from enrollment	30 day
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
Number of Participants With Colonoscopy-related Adverse Events	Colonoscopy-related adverse events will include hemorrhagic shock, and perforation.	0-4 day

Collaborators and Investigators

• Sponsor: Tokyo University
• Investigators: Study Director: Atsuo Yamada, MD, Tokyo University

Publications and helpful links

General 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.
• 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.

Helpful Links

• Early versus Elective Colonoscopy Trial

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2016
• Primary Completion (Actual): August 24, 2018
• Study Completion (Actual): January 4, 2019

Study Registration Dates

• First Submitted: March 26, 2017
• First Submitted That Met QC Criteria: March 27, 2017
• First Posted (Actual): March 31, 2017

Study Record Updates

• Last Update Posted (Actual): November 8, 2019
• Last Update Submitted That Met QC Criteria: October 21, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Rebleeding; Stigmata of recent hemorrhage; Early colonoscopy
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Hemorrhage; Gastrointestinal Hemorrhage
• Other Study ID Numbers: P2015034-11Y; UMIN000021129 (Other Identifier: University hospital Medical Information Network)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Study Data/Documents

1. Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No