Low volume bowel preparation for colonoscopy: randomized, endoscopist-blinded trial of liquid sodium phosphate versus tablet sodium phosphate

Balaban, David H.; Leavell, Byrd S.; Oblinger, Michael J.; Thompson, William O.; Bolton, Nancy D.; Pambianco, Daniel J.

doi:10.1111/j.1572-0241.2003.07380.x

Cited by 40 publications

(14 citation statements)

References 16 publications

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“…A lower RSS indicated better colon cleansing. The RSS grading system has been demonstrated to have a high degree of statistical correlation with the GPA (r = -0.76, P \ 0.001) [14].…”

Section: Evaluation Methodsmentioning

confidence: 99%

“…The bowel cleansing scoring system was similar to that previously described [14,15,20]. Examining endoscopists recorded a global preparation assessment (GPA) based on the following definitions: excellent = small or no volume of clear liquid, good = moderate or large volume of clear to semi-clear liquid, fair = some semi-solid stool that could be suctioned or washed away, or poor = some semisolid or solid stool that could not be suctioned or washed away.…”

Section: Evaluation Methodsmentioning

confidence: 99%

“…Fleet Co., Lynchburg, VA) is marketed as an over-the-counter laxative in the USA and as a bowel preparation worldwide. Because of the relatively small volume required, NaP has been extensively utilized and shown to be an effective cathartic for bowel cleansing prior to colonoscopy, radiographic procedures, and surgery [13][14][15][16][17][18][19][20]. The most commonly used dosage is a split regimen of two 45-ml doses separated by 6-12 h (45/45 ml).…”

Section: Introductionmentioning

confidence: 99%

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Randomized Study Comparing Two Regimens of Oral Sodium Phosphates Solution Versus Low-Dose Polyethylene Glycol and Bisacodyl

et al. 2008

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“…A lower RSS indicated better colon cleansing. The RSS grading system has been demonstrated to have a high degree of statistical correlation with the GPA (r = -0.76, P \ 0.001) [14].…”

Section: Evaluation Methodsmentioning

confidence: 99%

Section: Evaluation Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Randomized Study Comparing Two Regimens of Oral Sodium Phosphates Solution Versus Low-Dose Polyethylene Glycol and Bisacodyl

et al. 2008

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“…Secondly, the scale used to evaluate bowel cleansing is not fully validated. However, this scale has been subjected to construct validity and inter-observer reliability assessments [22,23]. Additionally, using pooled data from 477 subjects in three separate studies, colon polyps were detected in 48.7% of adequate preparations versus 37% of inadequate preparations (p=0.055).…”

Section: Discussionmentioning

confidence: 99%

Superiority of a Split-dose Regimen of Sodium Picosulfate/ Magnesium Citrate (SPMC) in Comparison to a Prior-day Schedule (AM/PM) for Colonoscopy Preparation. A Randomized Single-blinded Study

Schulz

Müller²,

Sauter

et al. 2016

JGLD

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Background & Aims: Split-dose regimens are generally recommended for bowel cleansers. However, other regimens still remain in the summary of product characteristics of some bowel cleansers in Europe. The aim of this study is to compare the efficacy and safety of a split-dose regimen of sodium picosulfate/magnesium citrate (SPMC) with a prior-day schedule (AM/PM). Methods: Multicenter, randomized (EudraCT no. 2013-001620-20), endoscopist-blinded, parallel study, carried out in subjects 18 years or older undergoing elective colonoscopy. The primary endpoint was the bowel cleansing assessment using a binary transformation (adequate/inadequate) of the Global Preparation Assessment (GPA) scale. Additional parameters analyzed were the segmental assessment of bowel cleansing (RSS), the adenoma detection rate and safety evaluations. Results: 315 subjects comprised the ITT set. A significantly higher proportion of patients in the split-dose regimen had an adequate bowel preparation (AM/PM: 30.8% vs split-dose: 79.9%; p<0.0001). The mean global RSS was significantly lower in the split-dose group (AM/PM: 5.0 [SD: 2.91] vs split-dose: 2.6 [SD: 2.14]; p<0.0001). Flat polyps were detected in a higher proportion of subjects in the split-dose group compared with the AM/PM group (AM/PM: 16.0% vs split-dose: 22.0%). Both regimens were equally safe and well tolerated, with no serious treatment-emergent adverse events or discontinuations due to adverse events. Conclusion: A split-dose regimen of SPMC is superior to the AM/PM regimen administered the day before colonoscopy. Split regimen of SPMC should be considered the standard of use. Abbreviations: CTCAE: Common Terminology Criteria for Adverse Events; eGFR: Glomerular filtration rate; mITT: modified intent-to-treat; RSS: Residual Stool Score; SA: safety analysis; SAE: serious adverse event; SmPC: summary of product characteristics; SPMC: sodium picosulfate-magnesium citrate.

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“…Th is scale does not separately record cleansing effi cacy in distinct segments of the colon as do a variety of other published scales that off er a more complete description of bowel cleansing (12,13) . Further, the scale permits the presence of residual formed stool ( " small amounts of feces or fl uid not interfering with the exam " ) even in " good " preparations.…”

Section: Conflict Of Interestmentioning

confidence: 99%

Editorial: A Light Breakfast, a Jug of Salt Water and Bowel

Balaban¹

2009

Am J Gastroenterol

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Successful colonoscopy is predicated on achieving adequate colon cleansing. An ideal bowel preparation would be low in volume, acceptable to patients, reliable in cleansing effi cacy, and safe. The study by Di Palma et al. in this issue shows that a novel, low-volume (960 ml) preparation of mixed sulfate salts can achieve excellent bowel cleansing with acceptable tolerability and minimal electrolyte shifts. A split-dosing strategy, with a proportion of the preparation administered on the day of colonoscopy, achieved a 97.2 % preparation success rate vs. 82.4 % using a regimen provided entirely the day before colonoscopy. These results were comparable with control groups using a commercially available polyethylene glycol solution. Endoscopists and patients alike should be encouraged by the trend toward lower-dose bowel cleansing regimens that achieve equivalent effi cacy compared with large-volume preparations. Am J Gastroenterol 2009; 104:2285-2287 doi: 10.1038/ajg.2009 It could be argued that there is no medication more commonly prescribed by a busy endoscopist than a bowel preparation. Yet, the volume of scientifi c literature on the pharmacokinetics, efficacy, and side eff ects of bowel cleansing agents used for colonoscopy and other medical procedures is scant when compared with other agents used for digestive health. Th e importance of bowel preparation before colonoscopy cannot be understated. Inadequate colon cleansing is associated with lower endoscopic yield for adenomas (1,2) , decreased fi nd rates for fl at lesions (3), and longer examinations (2) . Unfortunately, bowel preparation is oft en inadequate to permit complete examination of the colon (1) , necessitating shorter screening and surveillance intervals. Perhaps most importantly, patients report that the bowel preparation is both the leading deterrent to undergoing screening colonoscopy (4) and the most diffi cult part of the examination (5) .In this issue of the American Journal of Gastroenterology , Di Palma et al . report the results of a randomized, multicenter, industry-sponsored, endoscopist-blinded trial of a novel oral sulfate solution for pre-colonoscopic bowel preparation (6) . Study subjects were randomized to one of two therapeutic dosing strategies: same-day (PM before examination) vs. split-dose (PM / AM) preparation. Case subjects used two 480-ml doses of a solution comprised of sodium, potassium, and magnesium sulfate salts. Controls used two 1-L doses of a commercially available polyethylene glycol solution with electrolytes and ascorbic acid (PEG-EA, MoviPrep, Salix Pharmaceuticals, Morrisville, NC). Th e primary endpoint was bowel preparation success defi ned as a score of " excellent " or " good " using a previously published scale (7,8) . Tolerability was assessed using a questionnaire administered on the date of the examination.Th e intention-to-treat analysis included 387 subjects randomized to the same-day dosing strategy (194 sulfate, and 364 subjects in the split-dose strategy (181 sulfate, 183 PEG-EA). Bowel preparati...

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Low volume bowel preparation for colonoscopy: randomized, endoscopist-blinded trial of liquid sodium phosphate versus tablet sodium phosphate

Abstract: Liquid sodium phosphate is better tolerated and more effective at colon cleansing when compared with sodium phosphate in tablet form.

Cited by 40 publications

References 16 publications

Randomized Study Comparing Two Regimens of Oral Sodium Phosphates Solution Versus Low-Dose Polyethylene Glycol and Bisacodyl

Randomized Study Comparing Two Regimens of Oral Sodium Phosphates Solution Versus Low-Dose Polyethylene Glycol and Bisacodyl

Superiority of a Split-dose Regimen of Sodium Picosulfate/ Magnesium Citrate (SPMC) in Comparison to a Prior-day Schedule (AM/PM) for Colonoscopy Preparation. A Randomized Single-blinded Study

Editorial: A Light Breakfast, a Jug of Salt Water and Bowel

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