Evaluation of a Modified Bowel Preparation Regimen in Cirrhotic Patients Undergoing Colonoscopy

Summary

Inadequate bowel preparation compromises colonoscopy quality and diagnostic accuracy, and cirrhosis is a recognized independent predictor of poor bowel cleansing. However, no bowel preparation regimen has been prospectively validated or specifically tailored for cirrhotic patients. This multicenter, prospective, randomized, single-blind controlled clinical trial will evaluate whether the addition of adjunctive measures as an intensified bowel preparation protocol improves bowel cleansing quality in adult patients with cirrhosis undergoing elective outpatient colonoscopy. Participants will be randomized 1:1 to receive either a standard bowel preparation protocol, consisting of a 2-litre split-dose polyethylene glycol (PEG) regimen combined with a one-day low-residue diet and clear liquids the afternoon before the procedure (control), or the same split-dose regimen with the assigned adjunctive measures: 15 mg bisacodyl, a 3-day low-residue diet, and clear liquids the day before colonoscopy (intervention). The primary outcome is the proportion of patients achieving adequate bowel preparation, defined as a Boston Bowel Preparation Scale (BBPS) total score ≥6 with no individual segment score \<2. Secondary outcomes include polyp, adenoma, advanced adenoma and colorectal cancer detection rates, caecal intubation rate, patient compliance, tolerability, and adverse events. Pre-specified subgroup analyses will evaluate the influence of etiology and severity of cirrhosis and portal hypertension complications. By addressing a critical and unmet clinical need, this trial aims to generate high-quality evidence to optimize bowel preparation strategies in patients with cirrhosis, improve colonoscopy quality, and ultimately enhance colorectal cancer screening outcomes in this vulnerable population.

Timeline

Start

2026-08-01

Primary completion

2027-08-01

Completion

2027-10-30

Publications

• Results Jacobson BC, Anderson JC, Burke CA, Dominitz JA, Gross SA, May FP, Patel SG, Shaukat A, Robertson DJ. Optimizing Bowel Preparation Quality for Colonoscopy: Consensus Recommendations by the US Multi-Society Task Force on Colorectal Cancer. Gastroenterology. 2025 Apr;168(4):798-829. doi: 10.1053/j.gastro.2025.02.002. Epub 2025 Mar 4.
• Results Jeschek P, Ferlitsch A, Salzl P, Heinze G, Gyori G, Reinhart K, Waldmann E, Britto-Arias M, Trauner M, Ferlitsch M. A greater proportion of liver transplant candidates have colorectal neoplasia than in the healthy screening population. Clin Gastroenterol Hepatol. 2015 May;13(5):956-62. doi: 10.1016/j.cgh.2014.08.018. Epub 2014 Aug 20.
• Results Kugelmas M, Zapata I, Tawil J, Pessetto A, Taglienti M, Kugelmas M. Liver Cirrhosis Increases the Risk of Developing Advanced Colon Polyps. Dig Dis Sci. 2023 Mar;68(3):931-938. doi: 10.1007/s10620-022-07561-1. Epub 2022 Jun 7.
• Results Gundling F, Luxi M, Seidel H, Schepp W, Schmidt T. Small intestinal dysmotility in cirrhotic patients: correlation with severity of liver disease and cirrhosis-associated complications. Z Gastroenterol. 2021 Jun;59(6):540-550. doi: 10.1055/a-1162-0357. Epub 2020 Jun 8.
• Results Theocharidou E, Dhar A, Patch D. Gastrointestinal Motility Disorders and Their Clinical Implications in Cirrhosis. Gastroenterol Res Pract. 2017;2017:8270310. doi: 10.1155/2017/8270310. Epub 2017 May 11.
• Results Clayton DB, Palmer WC, Robison SW, Heckman MG, Chimato NT, Harnois DM, Francis DL. Colonoscopy bowel preparation quality improvement for patients with decompensated cirrhosis undergoing evaluation for liver transplantation. Clin Transplant. 2016 Oct;30(10):1236-1241. doi: 10.1111/ctr.12809.
• Results Gandhi K, Tofani C, Sokach C, Patel D, Kastenberg D, Daskalakis C. Patient Characteristics Associated With Quality of Colonoscopy Preparation: A Systematic Review and Meta-analysis. Clin Gastroenterol Hepatol. 2018 Mar;16(3):357-369.e10. doi: 10.1016/j.cgh.2017.08.016. Epub 2017 Aug 18.
• Results Hassan C, East J, Radaelli F, Spada C, Benamouzig R, Bisschops R, Bretthauer M, Dekker E, Dinis-Ribeiro M, Ferlitsch M, Fuccio L, Awadie H, Gralnek I, Jover R, Kaminski MF, Pellise M, Triantafyllou K, Vanella G, Mangas-Sanjuan C, Frazzoni L, Van Hooft JE, Dumonceau JM. Bowel preparation for colonoscopy: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - Update 2019. Endoscopy. 2019 Aug;51(8):775-794. doi: 10.1055/a-0959-0505. Epub 2019 Jul 11.
• Results Sulz MC, Kroger A, Prakash M, Manser CN, Heinrich H, Misselwitz B. Meta-Analysis of the Effect of Bowel Preparation on Adenoma Detection: Early Adenomas Affected Stronger than Advanced Adenomas. PLoS One. 2016 Jun 3;11(6):e0154149. doi: 10.1371/journal.pone.0154149. eCollection 2016.
• Results Clark BT, Rustagi T, Laine L. What level of bowel prep quality requires early repeat colonoscopy: systematic review and meta-analysis of the impact of preparation quality on adenoma detection rate. Am J Gastroenterol. 2014 Nov;109(11):1714-23; quiz 1724. doi: 10.1038/ajg.2014.232. Epub 2014 Aug 19.
• Results Anam AK, Karia K, Jesudian AB, Bosworth BP. Cirrhotic Patients Have Worse Bowel Preparation at Screening Colonoscopy than Chronic Liver Disease Patients without Cirrhosis. J Clin Exp Hepatol. 2016 Dec;6(4):297-302. doi: 10.1016/j.jceh.2016.08.009. Epub 2016 Aug 31.
• Results Gow-Lee B, Gaumnitz J, Alsadhan M, Garg G, Amoafo L, Zhang Y, Fang J, Rodriguez E. Cirrhosis and Portal Hypertension Worsen Bowel Preparation for Screening Colonoscopy. J Clin Gastroenterol. 2025 Jan 1;59(1):82-89. doi: 10.1097/MCG.0000000000001990.

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