Evidence map›Paper›PMID 33793636›Full record

Trial reportPloS one2021

A randomized controlled trial of high volume simethicone to improve visualization during capsule endoscopy.

Michael Sey, Brian Yan, Cassandra McDonald, Dan Segal, Joshua Friedland, Klajdi Puka, Vipul Jairath

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in PloS one, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02334631 (A Double Blind Randomized Controlled Trial of High Volume Simethicone to Improve Visualization During Capsule Endoscopy), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
2.3field-weighted citation impact, top 11% 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.

NCT02334631 phase4completednot on this map

A Double Blind Randomized Controlled Trial of High Volume Simethicone to Improve Visualization During Capsule Endoscopy

TypeinterventionalSponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sRan2017 to 2019Enrolled159ConditionsSmall Bowel DiseasesArmsHigh Volume Simethicone, Standard Volume Simethicone
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 16 citations in OpenAlex.

  1. Trial
  2. Article
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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

7 authors at 4 institutions in 1 country.

Michael SeyDivision of Gastroenterology, Department of Medicine, Western University, London, Ontario, Canada.ORCID 0000-0002-0337-2366
Brian YanDivision of Gastroenterology, Department of Medicine, Western University, London, Ontario, Canada.
Cassandra McDonaldLawson Health Research Institute, London Health Sciences Centre, London, Ontario, Canada.
Dan SegalNiagara Health System, McMaster University, Hamilton, Ontario, Canada.
Joshua FriedlandDepartment of Medicine, University of Toronto, Toronto, Ontario, Canada.
Klajdi PukaDepartment of Epidemiology and Biostatistics, Western University, London, Ontario, Canada.
Vipul JairathDivision of Gastroenterology, Department of Medicine, Western University, London, Ontario, Canada.
Western University · CALawson Health Research Institute · CANiagara Health System · CAUniversity of Toronto · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe optimal dose of simethicone before capsule endoscopy is unknown. Prior studies have reported inconsistent cleansing, with some showing improved visualization only in the proximal small intestine. We hypothesized a higher volume of simethicone may improve cleansing and diagnostic yield, especially in the distal small bowel.

methodsA phase III randomized controlled trial was conducted comparing high volume (1125 mg simethicone in 750 ml water) versus standard volume (300 mg simethicone in 200 ml water) solutions, both at 1.5 mg/ml. The primary outcome was adequate bowel preparation, defined as a KOrea-CanaDA (KODA) score >2.25, overall and stratified by the proximal and distal half of the small bowel. Secondary outcomes included mean KODA score, diagnostic yield, completion rate, and adverse events. All analyses were intention-to-treat.

resultsA total of 167 patients were randomized (mean (SD) age 58.7 (15.7), 54% female) and the most common indication was obscure gastrointestinal bleeding (71.7%). Adequate cleansing was achieved in 39 (50%) patients in the high volume group and in 39 (48%) patients in the standard volume group (RR 1.04, 95% CI 0.76-1.43, p = 0.82), with no differences observed in the proximal half (71% vs 64%, p = 0.40) or the distal half -of the small bowel (36% vs. 37%, p = 0.88). There was no differences in the mean (SD) KODA score (2.20 (0.41) vs. 2.18 (0.44), p = 0.73), diagnostic yields (53% vs. 56%, p = 0.71), or completion rates (both 95%). One adverse event, nausea, occurred in the control group.

conclusionHigh volume simethicone does not improve visualization during capsule endoscopy. CLINICAL

trial registrationClinical trial: NCT02334631.

Indexed as

Capsule EndoscopyAdultAgedCatharticsFemaleGastrointestinal HemorrhageHumansMaleMiddle AgedNauseaSimethiconeTreatment OutcomeCatharticsSimethicone

Identifiers

PMID33793636
PMCPMC8016230
OpenAlexW3148553192

What OpenQuestion holds

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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.