Rapid Colonoscopy Preparation Using Bolus Lukewarm Saline Combined with Sequential Posture Changes: A Randomized Controlled Trial
In this randomized clinical trial, we have compared the Shudh™ colon cleanse (SCC) with HalfLytely® colon prep (HCP) to evaluate the efficacy, bowel preparation time (BPT), adverse events, electrolyte abnormalities and patient acceptability.
Patients were randomized to receive either SCC (n = 65) or HCP (n = 68). All colonoscopies were performed by a single, blinded endoscopist. Colon prep was evaluated on a 5 point grading scale. Statistical non-inferiority was pre-defined as a difference of <15 % in the lower limit of the 95.5 % confidence interval for the treatment difference. Data that were collected include bowel prep score, BPT, adverse events, electrolyte abnormalities and patient acceptability.
Bowel preparation efficacy was rated as “successful” for 59/65 (90.7 %) in SCC versus 66/68 (97.1 %) in HCP. This gave a success difference of −6.4 % with a 1-sided 95 % lower confidence limit (LCI) for the difference = −13.3 % (non-inferiority p = 0.25). This difference fell within the predefined limit for non-inferiority. The average BPT for SCC was 1.9 h versus 10.9 in HCP (p < 0.001). No serious adverse events were reported in either group. None of the patients in either group had any clinically significant electrolyte imbalance. Patient ratings for palatability and willingness to repeat were significantly better for SCC (p < 0.05).
SCC was found to not be inferior to PEG with regards to the quality of bowel preparation. It is worth highlighting that a major advantage of SCC is shorter BPT. (Clinical trial registration number: NCT01547130).
- Cummings LC. Colorectal cancer screening: update 2011. Semin Oncol.. 2011;38:483–489. CrossRef
- Winawer SJ, Zauber AG, Ho MN, et al. Prevention of colorectal cancer by colonoscopic polypectomy. The National Polyp Study Workgroup. N Engl J Med. 1993;329:1977–1981. CrossRef
- National Center for Health Statistics. National Health Interview Survey, 2005. Hyattsville, Maryland: Public Health Service. Available at fttp://cdc.gov/pub/Health_Statistics/NCHS/Dataset_Documentation/NHIS/2005/cancerxx_freq.pdf; 2005 Accessed September 28, 2006.
- Holden DJ. Enhancing the use and quality of colorectal cancer screening. Evid Rep Technol Assess. (Full Rep) 2010 Feb;(190):1–195.
- Rex DK, Johnson DA, Anderson JC, Schoenfeld PS, Burke CA, Inadomi JM. American College of Gastroenterology guidelines for colorectal cancer screening 2009 [corrected]. Am J Gastroenterol. 2009;104:739–750. CrossRef
- Strul H, Arber N. Screening techniques for prevention and early detection of colorectal cancer in the average-risk population. Gastrointest Cancer Res. 2007;1:98–106.
- Harewood GC, Sharma VK, de Garmo P. Impact of colonoscopy preparation quality on detection of suspected colonic neoplasia. Gastrointest Endosc. 2003;58:76–79. CrossRef
- Lebwohl B, Kastrinos F, Glick M, Rosenbaum AJ, Wang T, Neugut AI. The impact of suboptimal bowel preparation on adenoma miss rates and the factors associated with early repeat colonoscopy. Gastrointest Endosc. 2011 June;73(6):1207–1214.
- Kastenberg D, Barish C, Burack H, et al. Tolerability and patient acceptance of sodium phosphate tablets compared with 4-L PEG solution in colon cleansing: combined results of 2 identically designed, randomized, controlled, parallel group, multicenter phase 3 trials. J Clin Gastroenterol. 2007;41:54–61. CrossRef
- Parente F, Marino B, Crosta C. Bowel preparation before colonoscopy in the era of mass screening for colo-rectal cancer: a practical approach. Dig Liver Dis. 2009;41:87–95. CrossRef
- Belsey J, Epstein O, Heresbach D. Systematic review: oral bowel preparation for colonoscopy. Aliment Pharmacol Ther. 2007;25:373–384. CrossRef
- Barnes PM, Powell-Griner E, McFann K, et al. Complementary and alternative medicine use among adults: United States, 2002. Adv Data. 2004;343:1–19.
- Barnes PM, Bloom B. Complementary and alternative medicine use among adults: United States, 2007. National Health Statistics (CDC). Natl Health Stat Rep. 2008;12:1–23.
- Lin M, Nahin R, Gershwin E, Longhurst J, et al. State of complementary and alternative medicine in cardiovascular, lung, and blood research: executive summary of a workshop. Circulation. 2001;103:2038–2041. CrossRef
- Galantino ML, Bzdewka TM, Eissler-Russo JL, et al. The impact of modified Hatha Yoga on chronic low back pain: a pilot study. Altern Ther. 2004;10:56–59.
- Walton K, Schneider R, Nidich S. Review of controlled research on the transcendental meditation program and cardiovascular disease. Risk factors, morbidity, and mortality. Cardiol Rev. 2004;12:262–266. CrossRef
- Yogendra J, Yogendra HJ, Ambardekar S, et al. Beneficial effects of yoga lifestyle on reversibility of ischaemic heart disease: caring heart project of International Board of Yoga. J Assoc Physicians India. 2004;52:283–289.
- Jacobs TL, Epel ES, Lin J, et al. Intensive meditation training, immune cell telomerase activity, and psychological mediators. Psychoneuroendocrinology. 2011;36:664–681. CrossRef
- Grant JA, Courtemanche J, Duerden EG, Duncan GH, Rainville P. Cortical thickness and pain sensitivity in zen meditators. Emotion. 2010;10:43–53. CrossRef
- Arya V, Gupta KA, Arya S. Efficacy of bolus lukewarm saline and yoga postures as a colonoscopy preparation: a pilot study. J Altern Complement Med. 2010;16:1269–1277. CrossRef
- Metabolic Equivalent (MET) values for activities in American time use survey (ATUS). National Cancer Institute, Accessed 09/15/2010. http://riskfactor.cancer.gov/tools/atus-met/met.php.
- McHugh PR, Moran TH. Calories and gastric emptying: a regulatory capacity with implications for feeding. Am Physiol Soc. 1979;236:R254–R260.
- Hunt JN, Macdonald I. The influence of volume on gastric emptying. J Physiol. 1954;126:459–474.
- Hunt JN, Stubbs DF. The volume and energy content of meals as determinants of gastric emptying. J Physiol. 1975;245:209–225.
- Erskine L, Hunt JN. The gastric emptying of small volumes given in quick succession. J Physiol. 1981;313:335–341.
- Tansy MF, Kendall FM. Experimental and clinical aspects of gastrocolic reflexes. Am J Dig Dis. 1973;18:521–531. CrossRef
- Mayer EA, Raybould HE. Role of visceral afferent mechanisms in functional bowel disorders. Gastroenterology. 1990;99:1688–1704.
- Jerath R, Edry JW, Barnes VA, Jerath V. Physiology of long pranayamic breathing: neural respiratory elements may provide a mechanism that explains how slow deep breathing shifts the autonomic nervous system. Med Hypotheses. 2006;67:566–571. CrossRef
- Sun WM, Houghton LA, Read NW, et al. Effect of meal temperature on gastric emptying of liquids in man. Gut. 1988;29:302–305. CrossRef
- Bateman DN. Effects of meal temperature and volume on the emptying of liquid from the human stomach. J Physiol. 1982;331:461–467.
- Dapoigny M, Sarna SK. Effects of physical exercise on colonic motor activity. Gastrointest Liver Physiol. 1991;260:G646–G652.
- Burn-Murdoch R, Fisher MA, et al. Does lying on the right side increase the rate of gastric emptying? J Physiol. 1980;302:395–398.
- Anvari M, Horowitz M, Fraser R, et al. Effects of posture on gastric emptying of nonnutrient liquids and antropyloroduodenal motility. Am Physiol Soc Am J Physiol. 1995;268:G868–G871.
- Amidon GL, DeBrincat GA, Najib N. Effects of gravity on gastric emptying, intestinal transit, and drug absorption. J Clin Pharmacol. 1991;31:968–973. CrossRef
- Gaylord SA, Palsson OS, Garland EL, et al. Mindfulness training reduces the severity of irritable bowel syndrome in women: results of a randomized controlled trial. Am J Gastroenterol. 2011;106:1678–1688. CrossRef
- Harvey RF, Read AE. Saline purgatives act by releasing cholecystokinin. Lancet. 1973;2:185–187. CrossRef
- American Society of Anesthesiologists Task Force on Sedation and Analgesia by Non-Anesthesiologists: Gross JB. Practice guidelines for sedation and analgesia by non-anesthesiologists. Anesthesiology. 2002 Apr;96(4):1004–1017.
- Lichtenstein DR, Jagannath S, Baron TH, et al. Sedation and anesthesia in GI endoscopy. Gastrointest Endosc. 2008;68:815–826. CrossRef
- Jonas DE, Russell LB, Sandler RS, Chou J, Pignone M. Patient time requirements for screening colonoscopy. Am J Gastroenterol. 2007;102:2401–2410. CrossRef
- Jonas DE, Russell LB, Sandler RS, Chou J, Pignone M. Value of patient time invested in the colonoscopy screening process: time requirements for colonoscopy study. Med Decis Making. 2008;28:56–65. CrossRef
- DiPalma JA, Wolff BG, Meagher A, et al. Comparison of reduced volume versus four liters sulfate-free electrolyte lavage solutions for colonoscopy colon cleansing. Am J Gastroenterol. 2003;98:2187–2191. CrossRef
- Matro R, Shnitser A, Spodik M, et al. Efficacy of morning-only compared with split-dose polyethylene glycol electrolyte solution for afternoon colonoscopy: a randomized controlled single-blind study. Am J Gastroenterol. 2010;105:1954–1961. CrossRef
- Ell C, Fischbach W, Bronisch HJ, et al. Randomized trial of low-volume PEG solution versus standard PEG + electrolytes for bowel cleansing before colonoscopy. Am J Gastroenterol. 2008;103:883–893. CrossRef
- Rex DK, Di Palma JA, Rodriguez R, McGowan J, Cleveland M. A randomized clinical study comparing reduced-volume oral sulfate solution with standard 4-liter sulfate-free electrolyte lavage solution as preparation for colonoscopy. Gastrointest Endosc. 2010;72:328–336. CrossRef
- Spiller RC, Trotman IF, Higgins BE, et al. The ileal brake—inhibition of jejunal motility after ileal fat perfusion in man. Gut. 1984;25:365–374. CrossRef
- Kim HS, Park DH, Kim JW, et al. Effectiveness of walking exercise as a bowel preparation for colonoscopy: a randomized controlled trial. Am J Gastroenterol. 2005;100:1964–1969. CrossRef
- Siddiqui AA, Yang K, Spechler SJ, et al. Duration of the interval between the completion of bowel preparation and the start of colonoscopy predicts bowel-preparation quality. Gastrointest Endosc. 2009;69:700–706. CrossRef
- Parra-Blanco A, Nicolas-Perez D, Gimeno-Garcia A, et al. The timing of bowel preparation before colonoscopy determines the quality of cleansing, and is a significant factor contributing to the detection of flat lesions: a randomized study. World J Gastroenterol. 2006;12:6161–6166.
- Gurudu SR, Ratuapli S, Heigh R, DiBaise J, Leighton J, Crowell M. Quality of bowel cleansing for afternoon colonoscopy is influenced by time of administration. Am J Gastroenterol. 2010;105:2318–2322. CrossRef
- Coremans G, Vos R, Margaritis V, Ghoos Y, Janssens J. Small doses of the unabsorbable substance polyethylene glycol 3350 accelerate oro-caecal transit, but slow gastric emptying in healthy patients. Dig Liver Dis. 2005;37:97–101. CrossRef
- Hewitt J, Reeve J, Rigby J et al. Whole-gut irrigation in preparation for large-bowl surgery. Lancet. 1973 Aug 18;2(7825):337–340.
- Levy AG, Benson JW, Hewlett EL, et al. Saline lavage: a rapid, effective, and acceptable method for cleansing the gastrointestinal tract. Gastroenterology. 1976;70:157–161.
- Postuma R. Whole bowel irrigation in pediatric patients. J Pediatr Surg. 1982;17:350–352. CrossRef
- Chattopadhyay A, Prakash B, Vepakomma D, et al. A prospective comparison of two regimes of bowel preparation for pediatric colorectal procedure: normal saline with added potassium vs. polyethylene glycol. Pediatric Surg Int. 2004;20:127–129. CrossRef
- Davis GR, Santa Ana CA, Morawski SG, Fordtran JS. Development of a lavage solution associated with minimal water and electrolyte absorption or secretion. Gastroenterology. 1980;78:991–995.
- Dong MH, Kalmaz D, Savides TJ. Missed work related to mid-week screening colonoscopy. Dig Dis Sci. 2011;56:2114–2119. CrossRef
- Di Palma JA, Rodriguez R, McGowan J, Cleveland MV. A randomized clinical study evaluating the safety and efficacy of a new, reduced-volume, oral sulfate colon-cleansing preparation for colonoscopy. Am J Gastroenterol. 2009;104:2275–2284. CrossRef
- Rapid Colonoscopy Preparation Using Bolus Lukewarm Saline Combined with Sequential Posture Changes: A Randomized Controlled Trial
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Digestive Diseases and Sciences
Volume 58, Issue 8 , pp 2156-2166
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- 1. 75-54 Metropolitan Ave, Midldle Village, NY, 11379, USA
- 2. Weill Medical College of Cornell University, Newyork, NY, USA
- 3. Division of Gastroenterology/Hepatobiliary Diseases, Wyckoff Heights Medical Center, Brooklyn, NY, USA
- 4. Brooklyn Hospital, Brooklyn, NY, USA
- 5. North Shore University Hospital, Manhasset, NY, USA
- 6. Methodist Hospital, Brooklyn, NY, USA
- 7. Wyckoff Heights Medical Center, Brooklyn, NY, USA
- 8. Cornell University, Ithaca, NY, USA
- 10. Department of Molecular Medicine, Hofstra North Shore-LIJ School of Medicine, New Hyde Park, NY, USA
- 11. Department of Population Health, Hofstra North Shore-LIJ School of Medicine, New Hyde Park, NY, USA
- 9. Biostatistics Unit, Feinstein Institute for Medical Research, Manhasset, NY, USA