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Completed

NCT Number: NCT03098173

Comparing Early Versus Elective Colonoscopy

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aichi Cancer Center Hospital, Nagoya, Aichi-ken, Japan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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.
  • Patients with severe cardiac failure.
  • Patients with active thrombosis.
  • Patients with severe respiratory failure.
  • Pregnant patients.

Treatment and study plan

Early colonoscopy

Procedure

Performance of prepared colonoscopy within 24 h of arrival

Elective colonoscopy

Procedure

Performance of prepared colonoscopy between 24 and 96 h after arrival

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Tokyo University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Mar 31, 2017
Registry last updated
Nov 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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