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

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Title: A novel volume-reduced CT colonography regimen using hypertonic laxative (polyethylene glycol with ascorbic acid): randomized controlled trial.
Authors: Utano, Kenichi1, Takayanagi, Daisuke1, Nagata, Koichi2, Aizawa, Masato1, Endo, Shungo1, Nemoto, Tetsutaro1, Nemoto, Daiki1, Isohata, Noriyuki1, Lefor, Alan Kawarai3, Togashi, Kazutomo1 togashik@fmu.ac.jp
Source: European Radiology. Oct2019, Vol. 29 Issue 10, p5236-5246. 11p. 4 Diagrams, 5 Charts, 1 Graph.
Subjects: Virtual colonoscopy, Polyethylene glycol, Vitamin C, Randomized controlled trials, Bowel preparation (Procedure), Laxatives, Therapeutic use of vitamin C, Therapeutic use of hypertonic solutions, Medical protocols, Evaluation research, Feces, Pilot projects, Longitudinal method, Research methodology, Research, Comparative studies, Colonoscopy
Abstract: Objectives: The 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.Methods: In 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.Results: A 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.Conclusions: A 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. [ABSTRACT FROM AUTHOR]
Copyright of European Radiology is the property of Springer Nature and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
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  Data: A novel volume-reduced CT colonography regimen using hypertonic laxative (polyethylene glycol with ascorbic acid): randomized controlled trial.
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  Data: <searchLink fieldCode="AR" term="%22Utano%2C+Kenichi%22">Utano, Kenichi</searchLink><relatesTo>1</relatesTo><br /><searchLink fieldCode="AR" term="%22Takayanagi%2C+Daisuke%22">Takayanagi, Daisuke</searchLink><relatesTo>1</relatesTo><br /><searchLink fieldCode="AR" term="%22Nagata%2C+Koichi%22">Nagata, Koichi</searchLink><relatesTo>2</relatesTo><br /><searchLink fieldCode="AR" term="%22Aizawa%2C+Masato%22">Aizawa, Masato</searchLink><relatesTo>1</relatesTo><br /><searchLink fieldCode="AR" term="%22Endo%2C+Shungo%22">Endo, Shungo</searchLink><relatesTo>1</relatesTo><br /><searchLink fieldCode="AR" term="%22Nemoto%2C+Tetsutaro%22">Nemoto, Tetsutaro</searchLink><relatesTo>1</relatesTo><br /><searchLink fieldCode="AR" term="%22Nemoto%2C+Daiki%22">Nemoto, Daiki</searchLink><relatesTo>1</relatesTo><br /><searchLink fieldCode="AR" term="%22Isohata%2C+Noriyuki%22">Isohata, Noriyuki</searchLink><relatesTo>1</relatesTo><br /><searchLink fieldCode="AR" term="%22Lefor%2C+Alan+Kawarai%22">Lefor, Alan Kawarai</searchLink><relatesTo>3</relatesTo><br /><searchLink fieldCode="AR" term="%22Togashi%2C+Kazutomo%22">Togashi, Kazutomo</searchLink><relatesTo>1</relatesTo><i> togashik@fmu.ac.jp</i>
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  Data: <searchLink fieldCode="JN" term="%22European+Radiology%22">European Radiology</searchLink>. Oct2019, Vol. 29 Issue 10, p5236-5246. 11p. 4 Diagrams, 5 Charts, 1 Graph.
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  Data: <searchLink fieldCode="DE" term="%22Virtual+colonoscopy%22">Virtual colonoscopy</searchLink><br /><searchLink fieldCode="DE" term="%22Polyethylene+glycol%22">Polyethylene glycol</searchLink><br /><searchLink fieldCode="DE" term="%22Vitamin+C%22">Vitamin C</searchLink><br /><searchLink fieldCode="DE" term="%22Randomized+controlled+trials%22">Randomized controlled trials</searchLink><br /><searchLink fieldCode="DE" term="%22Bowel+preparation+%28Procedure%29%22">Bowel preparation (Procedure)</searchLink><br /><searchLink fieldCode="DE" term="%22Laxatives%22">Laxatives</searchLink><br /><searchLink fieldCode="DE" term="%22Therapeutic+use+of+vitamin+C%22">Therapeutic use of vitamin C</searchLink><br /><searchLink fieldCode="DE" term="%22Therapeutic+use+of+hypertonic+solutions%22">Therapeutic use of hypertonic solutions</searchLink><br /><searchLink fieldCode="DE" term="%22Medical+protocols%22">Medical protocols</searchLink><br /><searchLink fieldCode="DE" term="%22Evaluation+research%22">Evaluation research</searchLink><br /><searchLink fieldCode="DE" term="%22Feces%22">Feces</searchLink><br /><searchLink fieldCode="DE" term="%22Pilot+projects%22">Pilot projects</searchLink><br /><searchLink fieldCode="DE" term="%22Longitudinal+method%22">Longitudinal method</searchLink><br /><searchLink fieldCode="DE" term="%22Research+methodology%22">Research methodology</searchLink><br /><searchLink fieldCode="DE" term="%22Research%22">Research</searchLink><br /><searchLink fieldCode="DE" term="%22Comparative+studies%22">Comparative studies</searchLink><br /><searchLink fieldCode="DE" term="%22Colonoscopy%22">Colonoscopy</searchLink>
– Name: Abstract
  Label: Abstract
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  Data: <bold>Objectives: </bold>The 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.<bold>Methods: </bold>In 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.<bold>Results: </bold>A 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.<bold>Conclusions: </bold>A novel CTC regimen using hypertonic laxative demonstrated optimal colon cleansing effectiveness even with the lowest volume of laxative (UMIN000022851).<bold>Key Points: </bold>• 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. [ABSTRACT FROM AUTHOR]
– Name: AbstractSuppliedCopyright
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  Data: <i>Copyright of European Radiology is the property of Springer Nature and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
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      – Type: doi
        Value: 10.1007/s00330-019-06127-6
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        Text: English
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      – SubjectFull: Virtual colonoscopy
        Type: general
      – SubjectFull: Polyethylene glycol
        Type: general
      – SubjectFull: Vitamin C
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      – SubjectFull: Randomized controlled trials
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      – SubjectFull: Bowel preparation (Procedure)
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      – SubjectFull: Laxatives
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      – SubjectFull: Therapeutic use of vitamin C
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      – SubjectFull: Therapeutic use of hypertonic solutions
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      – SubjectFull: Medical protocols
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      – SubjectFull: Evaluation research
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      – SubjectFull: Feces
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      – SubjectFull: Pilot projects
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      – SubjectFull: Longitudinal method
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      – SubjectFull: Research methodology
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      – SubjectFull: Colonoscopy
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              Text: Oct2019
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