Kenichi Utano1, Daisuke Takayanagi1, Koichi Nagata2, Masato Aizawa1, Shungo Endo1, Tetsutaro Nemoto1, Daiki Nemoto1, Noriyuki Isohata1, Alan Kawarai Lefor3, Kazutomo Togashi4. 1. Department of Coloproctology, Aizu Medical Center, Fukushima Medical University, 21-2 Maeda, Tanisawa, Kawahigashi, Aizuwakamatsu City, Fukushima, 969-3492, Japan. 2. Division of Screening Technology, National Cancer Center, Tokyo, Japan. 3. Department of Surgery, Jichi Medical University, Shimotsuke, Tochigi, Japan. 4. Department of Coloproctology, Aizu Medical Center, Fukushima Medical University, 21-2 Maeda, Tanisawa, Kawahigashi, Aizuwakamatsu City, Fukushima, 969-3492, Japan. togashik@fmu.ac.jp.
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.
RCT Entities:
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.
Authors: D Heresbach; M Djabbari; F Riou; C Marcus; A Le Sidaner; M A Pierredon-Foulogne; T Ponchon; M Boudiaf; J A Seyrig; H Laumonier; D Luet; M Giraud-Cohen; A L Pelletier; A Charachon; F Ramaholimihaso; P Bouillet; M Veyrac; S Ficarelli; K Vahedi; J Keruhel; H Lamouliatte; C Ridereau-Zins; Y Bouhnik; M Tissier; B Diris; A M Zagdanski; J M Josselin; S Hamonic; Y Gandon Journal: Gut Date: 2011-01-25 Impact factor: 23.059
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