Evidence map›Paper›PMID 30903329›Full record

Trial reportEuropean radiology2019

A novel volume-reduced CT colonography regimen using hypertonic laxative (polyethylene glycol with ascorbic acid): randomized controlled trial.

Kenichi Utano, Daisuke Takayanagi, Koichi Nagata, Masato Aizawa, Shungo Endo, Tetsutaro Nemoto, Daiki Nemoto, Noriyuki Isohata, Alan Kawarai Lefor, Kazutomo Togashi

Abstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in European radiology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.3field-weighted citation impact, top 38% 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

2 citing papers in PubMed, 7 citations in OpenAlex.

  1. Trial
  2. 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

10 authors at 2 institutions in 1 country.

Kenichi UtanoDepartment of Coloproctology, Aizu Medical Center, Fukushima Medical University, 21-2 Maeda, Tanisawa, Kawahigashi, Aizuwakamatsu City, Fukushima, 969-3492, Japan.
Daisuke TakayanagiDepartment of Coloproctology, Aizu Medical Center, Fukushima Medical University, 21-2 Maeda, Tanisawa, Kawahigashi, Aizuwakamatsu City, Fukushima, 969-3492, Japan.
Koichi NagataDivision of Screening Technology, National Cancer Center, Tokyo, Japan.
Masato AizawaDepartment of Coloproctology, Aizu Medical Center, Fukushima Medical University, 21-2 Maeda, Tanisawa, Kawahigashi, Aizuwakamatsu City, Fukushima, 969-3492, Japan.
Shungo EndoDepartment of Coloproctology, Aizu Medical Center, Fukushima Medical University, 21-2 Maeda, Tanisawa, Kawahigashi, Aizuwakamatsu City, Fukushima, 969-3492, Japan.
Tetsutaro NemotoDepartment of Coloproctology, Aizu Medical Center, Fukushima Medical University, 21-2 Maeda, Tanisawa, Kawahigashi, Aizuwakamatsu City, Fukushima, 969-3492, Japan.
Daiki NemotoDepartment of Coloproctology, Aizu Medical Center, Fukushima Medical University, 21-2 Maeda, Tanisawa, Kawahigashi, Aizuwakamatsu City, Fukushima, 969-3492, Japan.
Noriyuki IsohataDepartment of Coloproctology, Aizu Medical Center, Fukushima Medical University, 21-2 Maeda, Tanisawa, Kawahigashi, Aizuwakamatsu City, Fukushima, 969-3492, Japan.
Alan Kawarai LeforDepartment of Surgery, Jichi Medical University, Shimotsuke, Tochigi, Japan.
Kazutomo TogashiDepartment of Coloproctology, Aizu Medical Center, Fukushima Medical University, 21-2 Maeda, Tanisawa, Kawahigashi, Aizuwakamatsu City, Fukushima, 969-3492, Japan. togashik@fmu.ac.jp.ORCID http://orcid.org/0000-0002-4080-5335
Fukushima Medical University · JPJichi Medical University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesThe aim of this study is to investigate the feasibility of bowel preparation using a hypertonic laxative (polyethylene glycol with ascorbic acid, PEG + Asc) for CT colonography (CTC) and to examine the volume limit of laxative.

methodsIn one institution, patients who met the indications for CTC were enrolled and randomly assigned to CTC with regimen A (800 ml PEG + Asc), B (600 ml PEG + Asc), or C (400 ml PEG + Asc). Sodium diatrizoate was given orally for fecal tagging. On the previous day, patients ate low-residue meals and took the assigned lavage solution after dinner. A reader blinded to the preparation graded residual stool/fluid and fecal tagging quality in six segments of the colorectum. The primary outcome was a proportion of colon segments without stool. One hundred twenty segments in 20 patients with each regimen were needed to show a non-inferiority margin of 15%, assuming 85% of no stool.

resultsA total of 360 segments in 60 patients were analyzed. There were 83% of segments with no stool in regimen A, 89% in regimen B, and 88% in regimen C. Using the delta method, the 95% confidence interval of the risk difference (6.7%) between regimens A and B was - 2.2% to 15.6%, and the risk difference (5.0%) between regimens A and C was - 4.1% to 14%, both within the non-inferiority margin. Residual fluid and fecal tagging quality were also within the non-inferiority margin. No adverse events occurred.

conclusionsA novel CTC regimen using hypertonic laxative demonstrated optimal colon cleansing effectiveness even with the lowest volume of laxative (UMIN000022851). KEY POINTS: • A novel CTC regimen using a hypertonic laxative is feasible. • The lowest volume of laxative provides excellent colon imaging. • However, the lowest volume of laxative did not improve patient acceptance.

Indexed as

AdultAgedAscorbic AcidClinical ProtocolsColonography, Computed TomographicColonoscopyFeasibility StudiesFecesFemaleHumansHypertonic SolutionsLaxativesMaleMiddle AgedPolyethylene GlycolsProspective StudiesAscorbic AcidHypertonic SolutionsLaxativespolyethylene glycol 400Polyethylene GlycolsComputed tomographic colonographyLaxativesPolyethylene glycols

Identifiers

PMID30903329
OpenAlexW2924257057

What OpenQuestion holds

Textmetadata
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.