Evidence map›Paper›PMID 29615078›Full record

ArticleTrials2018

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.

Ryota Niikura, Naoyoshi Nagata, Atsuo Yamada, Hisashi Doyama, Yasutoshi Shiratori, Tsutomu Nishida, Shu Kiyotoki, Tomoyuki Yada, Tomoki Fujita, Tetsuya Sumiyoshi and 12 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03098173 (A Multi-center, Randomized Controlled Trial Comparing Early Versus Elective Colonoscopy in Outpatients With Acute Lower Gastrointestinal Bleeding), which is not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03098173 nacompletednot on this map

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

TypeinterventionalSponsorTokyo UniversityRan2016 to 2019Enrolled162ConditionsAcute Lower Gastrointestinal BleedingArmsEarly colonoscopy, Elective colonoscopy
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Early Colonoscopy Does Not Improve Outcomes of Patients With Lower Gastrointestinal Bleeding: Systematic Review of Randomized Trials.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2020
    Pooled it
  2. Article
  3. Initial management for acute lower gastrointestinal bleeding.World journal of gastroenterology · 2019
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

22 authors.

Ryota NiikuraDepartment of Gastroenterology, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 1138655, Japan. rniikura@triton.ocn.ne.jp.
Naoyoshi NagataDepartment of Gastroenterology and Hepatology, National Center for Global Health and Medicine, Shinjuku-ku, Tokyo, Japan.
Atsuo YamadaDepartment of Gastroenterology, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 1138655, Japan. yamada-a@umin.ac.jp.
Hisashi DoyamaDepartment of Gastroenterology, Ishikawa Prefectural Central Hospital, Kanazawa-shi, Ishikawa, Japan.
Yasutoshi ShiratoriDepartment of Gastroenterology, St. Luke's International Hospital, Chuo-ku, Tokyo, Japan.
Tsutomu NishidaDepartment of Gastroenterology, Toyonaka Municipal Hospital, Toyonaka-shi, Osaka, Japan.
Shu KiyotokiDepartment of Gastroenterology, Shuto General Hospital, Yanai-shi, Yamaguchi, Japan.
Tomoyuki YadaDepartment of Gastroenterology and Hepatology, National Center for Global Health and Medicine Kohnodai Hospital, Ichikawa-shi, Chiba, Japan.
Tomoki FujitaDepartment of Gastroenterology, Otaru Ekisaikai Hospital, Otaru-shi, Hokkaido, Japan.
Tetsuya SumiyoshiThe Center for Digestive Disease, Tonan Hospital, Sapporo-shi, Hokkaido, Japan.
Kenkei HasataniDepartment of Gastroenterology, Fukui Prefectural Hospital, Fukui-shi, Fukui, Japan.
Tatsuya MikamiDivision of Endoscopy, Hirosaki University Hospital, Hirosaki-shi, Aomori, Japan.
Tetsuro HondaDepartment of Gastroenterology, Nagasaki Harbor Medical Center City Hospital, Nagasaki-shi, Nagasaki, Japan.
Katsuhiro MabeDepartment of Gastroenterology, National Hospital Organization Hakodate Hospital, Hakodate-shi, Hokkaido, Japan.
Kazuo HaraDepartment of Gastroenterology, Aichi Cancer Center Hospital, Nagoya-shi, Aichi, Japan.
Katsumi YamamotoDepartment of Gastroenterology, Japan Community Healthcare Organization Osaka Hospital, Osaka-shi, Osaka, Japan.
Mariko TakedaClinical Research Support Center, The University of Tokyo Hospital, Bunkyo-ku, Tokyo, Japan.
Munenori TakataClinical Research Support Center, The University of Tokyo Hospital, Bunkyo-ku, Tokyo, Japan.
Mototsugu TanakaClinical Research Support Center, The University of Tokyo Hospital, Bunkyo-ku, Tokyo, Japan.
Tomohiro ShinozakiDepartment of Biostatistics, School of Public Health, The University of Tokyo, Bunkyo-ku, Tokyo, Japan.
Mitsuhiro FujishiroDepartment of Gastroenterology, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 1138655, Japan.
Kazuhiko KoikeDepartment of Gastroenterology, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 1138655, Japan.

Funding

The Japanese Gastroenterological Association 2016-1
6 · The paper itself

Abstract

backgroundThe clinical benefit of early colonoscopy within 24 h of arrival in patients with severe acute lower gastrointestinal bleeding (ALGIB) remains controversial. This trial will compare early colonoscopy (performed within 24 h) versus elective colonoscopy (performed between 24 and 96 h) to examine the identification rate of stigmata of recent hemorrhage (SRH) in ALGIB patients. We hypothesize that, compared with elective colonoscopy, early colonoscopy increases the identification of SRH and subsequently improves clinical outcomes.

methodsThis trial is an investigator-initiated, multicenter, randomized, open-label, parallel-group trial examining the superiority of early colonoscopy over elective colonoscopy (standard therapy) in ALGIB patients. The primary outcome measure is the identification of SRH. Secondary outcomes include 30-day rebleeding, success of endoscopic treatment, need for additional endoscopic examination, need for interventional radiology, need for surgery, need for transfusion during hospitalization, length of stay, 30-day thrombotic events, 30-day mortality, preparation-related adverse events, and colonoscopy-related adverse events. The sample size will enable detection of a 9% SRH rate in elective colonoscopy patients and a SRH rate of ≥ 26% in early colonoscopy patients with a risk of type I error of 5% and a power of 80%. DISCUSSION: This trial will provide high-quality data on the benefits and risks of early colonoscopy in ALGIB patients.

trial registrationUMIN-CTR Identifier, UMIN000021129 . Registered on 21 February 2016; ClinicalTrials.gov Identifier, NCT03098173 . Registered on 24 March 2017.

Indexed as

ColonoscopyAmbulatory CareEarly DiagnosisEquivalence Trials as TopicGastrointestinal HemorrhageHemostasis, EndoscopicHumansJapanMulticenter Studies as TopicPredictive Value of TestsRecurrenceTime FactorsTreatment OutcomeAcute lower gastrointestinal bleedingEarly colonoscopyElective colonoscopyHemostasisRebleedingStigmata of recent hemorrhage

Identifiers

PMID29615078
PMCPMC5883587

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.