NCT03098173

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
162

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 29, 2016

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 26, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 31, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 24, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 4, 2019

Completed
10 months until next milestone

Results Posted

Study results publicly available

November 8, 2019

Completed
Last Updated

November 8, 2019

Status Verified

October 1, 2019

Enrollment Period

2.6 years

First QC Date

March 26, 2017

Results QC Date

September 26, 2019

Last Update Submit

October 21, 2019

Conditions

Acute Lower Gastrointestinal Bleeding

Keywords

Early colonoscopyStigmata of recent hemorrhageRebleeding

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • Success Rate of Endoscopic Treatment; Number of Participants Achieving Hemostasis With Endoscopic Treatment

    0-4 day

  • Need for Additional Endoscopic Examinations

    0-34 day

  • Need for Interventional Radiology

    0-34 day

  • Need for Surgery

    0-34 day

  • Thirty-day Rebleeding Rates

    30 day

  • +6 more secondary outcomes

Study Arms (2)

Early colonoscopy

EXPERIMENTAL

Performance of prepared colonoscopy within 24 h of arrival

Procedure: Early colonoscopy

Elective colonoscopy

ACTIVE COMPARATOR

Performance of prepared colonoscopy between 24 and 96 h after arrival

Procedure: Elective colonoscopy

Interventions

Early colonoscopyPROCEDURE

Performance of prepared colonoscopy within 24 h of arrival

Early colonoscopy
Elective colonoscopyPROCEDURE

Performance of prepared colonoscopy between 24 and 96 h after arrival

Elective colonoscopy

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • Provision of signed and dated informed consent form.
  • Stated willingness to comply with all study procedures and availability for the duration of the study.

You may not qualify if:

  • An individual who meets any of the following criteria will be excluded from participation in this study:
  • Patients with hematemesis, black vomiting, or melena.
  • Patients with upper gastrointestinal bleeding, diagnosed by nasogastric tube or upper endoscopy.
  • Patients who have impossible consumed the oral bowel preparation solution.
  • Patients who have undergone computed tomography.
  • Patients who have been diagnosed with peptic ulcer diseases within the previous 10 days.
  • Ulcerative colitis or Crohn's disease patients.
  • Patients who have undergone abdominal surgery within the previous 10 days.
  • Patients who have undergone polypectomy, endoscopic mucosal resection, or endoscopic submucosal dissection of the lower gastrointestinal tract within the previous 10 days.
  • Patients with suspected perforation or peritonitis.
  • Patients with suspected intestinal obstruction.
  • Patients with hemorrhagic shock refractory to infusion or blood transfusion.
  • Patients who have undergone total colectomy.
  • Patients with suspected disseminated intravascular coagulation.
  • Patients with end-stage malignant disease.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Aichi Cancer Center Hospital

Nagoya, Aichi-ken, Japan

Location

Hirosaki University Hospital

Hirosaki-shi, Aomori, Japan

Location

National Center for Global Health and Medicine kohnodai hospital

Ichikawa-shi, Chiba, Japan

Location

Fukui prefectural hospital

Fukui-shi, Fukui, Japan

Location

National Hospital Organization Hakodate Hospital

Hakodate-shi, Hokkaido, Japan

Location

Otaru Ekisaikai Hospital

Otaru-shi, Hokkaido, Japan

Location

Tonan Hospital

Sapporo, Hokkaido, Japan

Location

Ishikawa prefectural central hospital

Kanazawa, Ishikawa-ken, Japan

Location

Nagasaki Harbor Medical Center City Hospital

Nagasaki, Nagasaki, Japan

Location

Japan Community Healthcare Organization Osaka Hospital

Fukushima-shi, Osaka, Japan

Location

Toyonaka Municipal Hospital

Toyonaka-shi, Osaka, Japan

Location

The University of Tokyo

Bunkyo-ku, Tokyo, Japan

Location

St. Luke's International Hospital

Chuo-ku, Tokyo, Japan

Location

National Center for Global Health and Medicine center hospital

Shinjuku-ku, Tokyo, Japan

Location

Shuto General Hospital

Yanai-shi, Yamaguchi, Japan

Location

Related Publications (3)

  • 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.

    PMID: 28042393BACKGROUND

  • 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.

    PMID: 31563627DERIVED

  • 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.

    PMID: 29615078DERIVED

Limitations and Caveats

Non blinding

Results Point of Contact

Title
Dr. Ryota Niikura
Organization
Tokyo University
niikura-dky@umin.ac.jp
+81-3-3815-5411

Study Officials

  • Atsuo Yamada, MD

    Tokyo University

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel, randomized, superiority trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Gastroenterology

Study Record Dates

First Submitted

March 26, 2017

First Posted

March 31, 2017

Study Start

January 29, 2016

Primary Completion

August 24, 2018

Study Completion

January 4, 2019

Last Updated

November 8, 2019

Results First Posted

November 8, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

JP(15)