Clinical trial NCT03098173: Comparing Early Versus Elective Colonoscopy
Official title: A Multi-center, Randomized Controlled Trial Comparing Early Versus Elective Colonoscopy in Outpatients With Acute Lower Gastrointestinal Bleeding
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Lower Gastrointestinal Bleeding
Keywords: Early colonoscopy
Stigmata of recent hemorrhage
Rebleeding
Lead sponsor: Tokyo University
Sponsor class: OTHER
First posted: 2017-03-31
Enrollment: 162
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel, randomized, superiority trial
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Stigmata of Recent Hemorrhage (SRH) Identification Rate
timeFrame: 0-4 day
Secondary outcomes:
measure: Success Rate of Endoscopic Treatment; Number of Participants Achieving Hemostasis With Endoscopic Treatment
timeFrame: 0-4 day
measure: Need for Additional Endoscopic Examinations
timeFrame: 0-34 day
measure: Need for Interventional Radiology
timeFrame: 0-34 day
measure: Need for Surgery
timeFrame: 0-34 day
measure: Thirty-day Rebleeding Rates
timeFrame: 30 day
measure: Need for Transfusion During Hospitalization
timeFrame: During hospitalization
measure: Length of Stay
timeFrame: 0-34 day
measure: Number of Participants With Thirty-day Thrombosis Events
timeFrame: 30 day
measure: Number of Participants With Thirty-day Death Events
timeFrame: 30 day
measure: Number of Participants With Preparation-related Adverse Events
timeFrame: 0-4 day
measure: Number of Participants With Colonoscopy-related Adverse Events
timeFrame: 0-4 day
Other outcomes:
Locations:
city: Nagoya-shi
country: Japan
facility: Aichi Cancer Center Hospital
state: Aichi
city: Hirosaki-shi
country: Japan
facility: Hirosaki University Hospital
state: Aomori
city: Ichikawa-shi
country: Japan
facility: National Center for Global Health and Medicine kohnodai hospital
state: Chiba
city: Fukui-shi
country: Japan
facility: Fukui prefectural hospital
state: Fukui
city: Hakodate-shi
country: Japan
facility: National Hospital Organization Hakodate Hospital
state: Hokkaido
city: Otaru-shi
country: Japan
facility: Otaru Ekisaikai Hospital
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Tonan Hospital
state: Hokkaido
city: Kanazawa city
country: Japan
facility: Ishikawa prefectural central hospital
state: Ishikawa
city: Nagasaki-shi
country: Japan
facility: Nagasaki Harbor Medical Center City Hospital
state: Nagasaki
city: Fukushima-shi
country: Japan
facility: Japan Community Healthcare Organization Osaka Hospital
state: Osaka
city: Toyonaka-shi
country: Japan
facility: Toyonaka Municipal Hospital
state: Osaka
city: Bunkyo-ku
country: Japan
facility: The University of Tokyo
state: Tokyo
city: Chuo-ku
country: Japan
facility: St. Luke's International Hospital
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: National Center for Global Health and Medicine center hospital
state: Tokyo
city: Yanai-shi
country: Japan
facility: Shuto General Hospital
state: Yamaguchi
Study officials:
affiliation: Tokyo University
name: Atsuo Yamada, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.