Colon Preparation With 2L PEG in Combination With Lubiprostone vs 4L PEG

Summary

Colonoscopy is the current standard method for examination of the colon. Bowel cleansing prior to colonoscopy is the essential prerequisite to ensure complete mucosal visualization and lesion identification.(1,2) Suboptimal preparations are associated with missed diagnoses, longer procedure times and increased costs related to the repeat procedures and shortened intervals between procedures.(3-5) Inadequate preparations have been noted in around 25 % cases in the US.(4,6) This has been attributed primarily to poor patient tolerance to the standard colon preparations. Osmotically balanced polyethylene glycol (PEG) electrolyte bowel lavage solutions were introduced in 1980.(7) These PEG based solutions are the most commonly used bowel preparations today.(7) They have high efficacy, are safe and are associated with minimal fluid and electrolyte imbalance. However the major drawback of these preparations is the taste and the large volumes required with associated nausea, cramping and vomiting.(8) This often results in poor compliance and tolerance with resultant poor preparation and improper visualization. A pooled analysis of 15 trials found that at least 29 % of patients were unable to complete their PEG solution.(9) Lubiprostone (LB) is a locally acting selective Type 2 chloride channel activator which causes intestinal fluid secretion. This results in increased softened stool and increased intestinal transit without the loss of either net intravascular fluid or electrolytes.(10) Peak plasma levels occur approximately 1.14 h after oral administration of a single 24 microgram dose, and the half-life of lubiprostone (t½) has been estimated at approximately 3 h.(11,12) LB is currently approved for the treatment of chronic idiopathic constipation and is generally well tolerated with an excellent side effect profile. Even long term usage has not shown clinically significant changes in electrolyte levels.(10,13) Our hypothesis was that administration of LB in addition to low volume (2-L) split-dose PEG would improve the adequacy of the bowel preparation as comparable as standard 4-L split-dose PEG regimens. Additionally, it could improve patient tolerability and decreased side effects related to the large volume of PEG regimens. Accordingly, we conducted this prospective, single-blind, randomized controlled trial.

Timeline

Start

2019-12-01

Primary completion

2021-06-30

Completion

2021-07-30

Publications

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• Results Seeff LC, Nadel MR, Klabunde CN, Thompson T, Shapiro JA, Vernon SW, Coates RJ. Patterns and predictors of colorectal cancer test use in the adult U.S. population. Cancer. 2004 May 15;100(10):2093-103. doi: 10.1002/cncr.20276.
• Results Froehlich F, Wietlisbach V, Gonvers JJ, Burnand B, Vader JP. Impact of colonic cleansing on quality and diagnostic yield of colonoscopy: the European Panel of Appropriateness of Gastrointestinal Endoscopy European multicenter study. Gastrointest Endosc. 2005 Mar;61(3):378-84. doi: 10.1016/s0016-5107(04)02776-2.
• Results 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 May;78(5 Pt 1):991-5.
• Results Adamcewicz M, Bearelly D, Porat G, Friedenberg FK. Mechanism of action and toxicities of purgatives used for colonoscopy preparation. Expert Opin Drug Metab Toxicol. 2011 Jan;7(1):89-101. doi: 10.1517/17425255.2011.542411.
• Results Tan JJ, Tjandra JJ. Which is the optimal bowel preparation for colonoscopy - a meta-analysis. Colorectal Dis. 2006 May;8(4):247-58. doi: 10.1111/j.1463-1318.2006.00970.x.
• Results Lacy BE, Levy LC. Lubiprostone: a chloride channel activator. J Clin Gastroenterol. 2007 Apr;41(4):345-51. doi: 10.1097/01.mcg.0000225665.68920.df.
• Results Lacy BE, Levy LC. Lubiprostone: a novel treatment for chronic constipation. Clin Interv Aging. 2008;3(2):357-64. doi: 10.2147/cia.s2938.
• Results Owen RT. Lubiprostone--a novel treatment for irritable bowel syndrome with constipation. Drugs Today (Barc). 2008 Sep;44(9):645-52. doi: 10.1358/dot.2008.44.9.1269852.
• Results Grigg E, Schubert MC, Hall J, Rahhal F, Raina D, Sridhar S, Chamberlain SM. Lubiprostone used with polyethylene glycol in diabetic patients enhances colonoscopy preparation quality. World J Gastrointest Endosc. 2010 Jul 16;2(7):263-7. doi: 10.4253/wjge.v2.i7.263.
• Results Lai EJ, Calderwood AH, Doros G, Fix OK, Jacobson BC. The Boston bowel preparation scale: a valid and reliable instrument for colonoscopy-oriented research. Gastrointest Endosc. 2009 Mar;69(3 Pt 2):620-5. doi: 10.1016/j.gie.2008.05.057. Epub 2009 Jan 10.
• Results Calderwood AH, Jacobson BC. Comprehensive validation of the Boston Bowel Preparation Scale. Gastrointest Endosc. 2010 Oct;72(4):686-92. doi: 10.1016/j.gie.2010.06.068.
• Results Stengel JZ, Jones DP. Single-dose lubiprostone along with split-dose PEG solution without dietary restrictions for bowel cleansing prior to colonoscopy: a randomized, double-blind, placebo-controlled trial. Am J Gastroenterol. 2008 Sep;103(9):2224-30. doi: 10.1111/j.1572-0241.2008.02053.x. Epub 2008 Aug 5.

Drugs

Indications

No indication recorded.