Evidence map›Paper›PMID 38310266›Full record

ArticleBMC gastroenterology2024

Comparison of the efficacy and tolerability of elobixibat plus sodium picosulfate with magnesium citrate and split-dose 2-L polyethylene glycol with ascorbic acid for bowel preparation before outpatient colonoscopy: a study protocol for the multicentre, randomised, controlled E-PLUS trial.

Kinichi Hotta, Yosuke Otake, Daisuke Yamaguchi, Yuichi Shimodate, Norihiro Hanabata, Hiroaki Ikematsu, Yohei Yabuuchi, Yasushi Sano, Ryo Shimoda, Shinya Sugimoto and 14 more

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC gastroenterology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.8field-weighted citation impact, top 25% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 3 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
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

24 authors at 10 institutions in 1 country.

Kinichi HottaDivision of Endoscopy, Shizuoka Cancer Center, 1007 Shimonagakubo, Nagaizumi-Cho, Sunto-Gun, Shizuoka, 411-8777, Japan. k.hotta@scchr.jp.ORCID http://orcid.org/0000-0001-5608-0968
Yosuke OtakeDepartment of Gastroenterology, Subaru Health Insurance Society Ota Memorial Hospital, Ota, Japan.
Daisuke YamaguchiDepartment of Gastroenterology, National Hospital Organization Ureshino Medical Center, Ureshino, Japan.
Yuichi ShimodateDepartment of Gastroenterology and Hepatology, Kurashiki Central Hospital, Kurashiki, Japan.
Norihiro HanabataDepartment of Gastroenterology, Aomori Prefectural Central Hospital, Aomori, Japan.
Hiroaki IkematsuEndoscopy Division, National Cancer Center Hospital East, Kashiwa, Japan.
Yohei YabuuchiDepartment of Gastroenterology, Kobe City Medical Center General Hospital, Kobe, Japan.
Yasushi SanoGastrointestinal Center, Sano Hospital, Kobe, Japan.
Ryo ShimodaDepartment of Internal Medicine, Division of Gastroenterology, Faculty of Medicine, Saga University, Saga, Japan.
Shinya SugimotoDepartment of Gastroenterology, Japanese Red Cross Ise Hospital, Ise, Japan.
Mari ObaNational Center of Neurology and Psychiatry, Tokyo, Japan.
Hiroyuki TakamaruEndoscopy Division, National Cancer Center Hospital, Tokyo, Japan.
Kouichiro KimuraDepartment of Gastroenterology, Subaru Health Insurance Society Ota Memorial Hospital, Ota, Japan.
Yoshihiro KishidaDivision of Endoscopy, Shizuoka Cancer Center, 1007 Shimonagakubo, Nagaizumi-Cho, Sunto-Gun, Shizuoka, 411-8777, Japan.
Kazunori TakadaDivision of Endoscopy, Shizuoka Cancer Center, 1007 Shimonagakubo, Nagaizumi-Cho, Sunto-Gun, Shizuoka, 411-8777, Japan.
Sayo ItoDivision of Endoscopy, Shizuoka Cancer Center, 1007 Shimonagakubo, Nagaizumi-Cho, Sunto-Gun, Shizuoka, 411-8777, Japan.
Kenichiro ImaiDivision of Endoscopy, Shizuoka Cancer Center, 1007 Shimonagakubo, Nagaizumi-Cho, Sunto-Gun, Shizuoka, 411-8777, Japan.
Kazuya HosotaniDepartment of Gastroenterology, Kobe City Medical Center General Hospital, Kobe, Japan.
Tatsuro MuranoEndoscopy Division, National Cancer Center Hospital East, Kashiwa, Japan.
Masayoshi YamadaEndoscopy Division, National Cancer Center Hospital, Tokyo, Japan.
Kensuke ShinmuraEndoscopy Division, National Cancer Center Hospital East, Kashiwa, Japan.
Rio TakezawaDepartment of Gastroenterology and Hepatology, Kurashiki Central Hospital, Kurashiki, Japan.
Michito TomonagaDepartment of Internal Medicine, Division of Gastroenterology, Faculty of Medicine, Saga University, Saga, Japan.
Yutaka SaitoEndoscopy Division, National Cancer Center Hospital, Tokyo, Japan.
National Cancer Center Hospital East · JPShizuoka Cancer Center · JPFuji Heavy Industries Health Insurance Society Ota Memorial Hospital · JPKobe City Medical Center General Hospital · JPKurashiki Central Hospital · JPSaga University · JPAomori Prefectural Central Hospital · JPIse Red Cross Hospital · JPNational Center of Neurology and Psychiatry · JPNational Hospital Organization · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSodium picosulfate (SP)/magnesium citrate (MC) and polyethylene glycol (PEG) plus ascorbic acid are recommended by Western guidelines as laxative solutions for bowel preparation. Clinically, SP/MC has a slower post-dose defaecation response than PEG and is perceived as less cleansing; therefore, it is not currently used for major bowel cancer screening preparation. The standard formulation for bowel preparation is PEG; however, a large dose is required, and it has a distinctive flavour that is considered unpleasant. SP/MC requires a small dose and ensures fluid intake because it is administered in another beverage. Therefore, clinical trials have shown that SP/MC is superior to PEG in terms of acceptability. We aim to compare the novel bowel cleansing method (test group) comprising SP/MC with elobixibat hydrate and the standard bowel cleansing method comprising PEG plus ascorbic acid (standard group) for patients preparing for outpatient colonoscopy.

methodsThis phase III, multicentre, single-blind, noninferiority, randomised, controlled, trial has not yet been completed. Patients aged 40-69 years will be included as participants. Patients with a history of abdominal or pelvic surgery, constipation, inflammatory bowel disease, or severe organ dysfunction will be excluded. The target number of research participants is 540 (standard group, 270 cases; test group, 270 cases). The primary endpoint is the degree of bowel cleansing (Boston Bowel Preparation Scale [BBPS] score ≥ 6). The secondary endpoints are patient acceptability, adverse events, polyp/adenoma detection rate, number of polyps/adenomas detected, degree of bowel cleansing according to the BBPS (BBPS score ≥ 8), degree of bowel cleansing according to the Aronchik scale, and bowel cleansing time. DISCUSSION: This trial aims to develop a "patient-first" colon cleansing regimen without the risk of inadequate bowel preparation by using both elobixibat hydrate and SP/MC.

trial registrationJapan Registry of Clinical Trials (jRCT; no. s041210067; 9 September 2021; https://jrct.niph.go.jp/ ), protocol version 1.5 (May 1, 2023).

Indexed as

CitratesCitric AcidDipeptidesOrganometallic CompoundsPicolinesPolyethylene GlycolsPolypsThiazepinesAscorbic AcidCatharticsClinical Trials, Phase III as TopicColonoscopyEquivalence Trials as TopicHumansMulticenter Studies as TopicOutpatientsAscorbic AcidCatharticsCitratesCitric AcidDipeptideselobixibatmagnesium citrateOrganometallic CompoundsPicolinespicosulfate sodiumPolyethylene GlycolsThiazepinesBoston bowel preparation scaleBowel preparationColonoscopyElobixibatPolyethylene glycolSodium picosulfate magnesium citrate

Identifiers

PMID38310266
PMCPMC10837887
OpenAlexW4391512863

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.