N/A
N=162
Comparing Early Versus Elective Colonoscopy
Acute Lower Gastrointestinal Bleeding
Bottom Line
View on ClinicalTrials.gov: NCT03098173 ↗Enrolled (actual)
162
Serious AEs
1.3%
Results posted
Nov 2019
Primary outcome: Primary: Stigmata of Recent Hemorrhage (SRH) Identification Rate — 17; 17 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Early colonoscopy (Procedure); Elective colonoscopy (Procedure)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Tokyo University
- Primary completion
- Aug 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Stigmata of Recent Hemorrhage (SRH) Identification Rate |
17; 17 | — |
| SECONDARY Success Rate of Endoscopic Treatment; Number of Participants Achieving Hemostasis With Endoscopic Treatment |
14; 15 | — |
| SECONDARY Need for Additional Endoscopic Examinations |
31; 23 | — |
| SECONDARY Need for Interventional Radiology |
1; 0 | — |
| SECONDARY Need for Surgery |
0; 0 | — |
| SECONDARY Thirty-day Rebleeding Rates |
11; 5 | — |
| SECONDARY Need for Transfusion During Hospitalization |
30; 26 | — |
| SECONDARY Length of Stay |
7.1; 7.6 | — |
| SECONDARY Number of Participants With Thirty-day Thrombosis Events |
1; 0 | — |
| SECONDARY Number of Participants With Thirty-day Death Events |
0; 0 | — |
| SECONDARY Number of Participants With Preparation-related Adverse Events |
36; 28 | — |
| SECONDARY Number of Participants With Colonoscopy-related Adverse Events |
1; 0 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03098173). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.