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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]
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Abstract:<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]
ISSN:09387994
DOI:10.1007/s00330-019-06127-6