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

NCT07668778 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: 1640/CES-HDESPD/2026
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Cirrhosis; Bowel Preparation

Keywords

Inadequate bowel preparation; Cirrhosis

Outcome Measures

Primary Outcomes (1)

• Adequate bowel preparation

  Proportion of participants with adequate bowel preparation, defined as a Boston Bowel Preparation Scale (BBPS) total score of 6 or higher, with a score of at least 2 in each colonic segment. The BBPS ranges from 0 to 9, with higher scores indicating better bowel cleansing.

  Periprocedural

Secondary Outcomes (11)

• Total Boston Bowel Preparation Scale score

  Periprocedural

• Polyp detection rate

  Periprocedural

• Adenoma detection rate

  Up to 30 days after colonoscopy

• Advanced adenoma detection rate

  Up to 30 days after colonoscopy

• Colorectal cancer detection rate

  Up to 30 days after colonoscopy

Other Outcomes (1)

• Adverse events

  From bowel preparation initiation until 30 days after colonoscopy

Study Arms (2)

Regimen A

ACTIVE COMPARATOR

2-L split-dose PEG + 1-day low-fibre diet + clear liquids on the afternoon before colonoscopy

Drug: 2-L PEG plus 1-day low fibre diet

Regimen B

EXPERIMENTAL

2-L split-dose PEG + 15 mg bisacodyl + 3-day low fibre diet + clear liquids on the day before colonoscopy

Drug: 2-L PEG plus bisacodyl plus 3-day low fibre diet

Interventions

2-L PEG plus 1-day low fibre diet DRUG

2-L split-dose polyethylene glycol bowel preparation combined with a 1-day low-fibre diet and clear liquids the afternoon before colonoscopy

Also known as: Cleansia

Regimen A

2-L PEG plus bisacodyl plus 3-day low fibre diet DRUG

2-L split-dose polyethylene glycol combined with 15 mg bisacodyl the afternoon before colonoscopy, a 3-day low-fibre diet, and clear liquids the day before colonoscopy

Also known as: Bisacodyl, Cleansia

Regimen B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Established diagnosis of cirrhosis, scheduled for elective outpatient total colonoscopy
• Age ≥ 18 years
• Ability to follow verbal and written instructions in Portuguese

You may not qualify if:

• Urgent procedures
• Colonoscopies not intended to reach the caecum
• History of any colonic surgery
• Absolute contraindication to bowel preparation or colonoscopy
• Active hepatic encephalopathy (West Haven grade ≥2) at the time of enrolment
• Refractory ascites, defined as ascites unresponsive to maximum diuretic therapy or requiring repeated large-volume paracentesis
• Severe hyponatraemia (serum sodium \<125 mEq/L) at the time of enrolment
• Subject refusal or inability to comprehend the trial

Sponsors & Collaborators

• Hospital do Divino Espírito Santo de Ponta Delgada: lead

Study Sites (4)

Hospital Central do Funchal, SESARAM

Funchal, Madeira, 9004-514, Portugal

Location

Hospital do Divino Espírito Santo de Ponta Delgada

Ponta Delgada, São Miguel, 9500-370, Portugal

Location

ULS de Coimbra

Coimbra, 3004-561, Portugal

Location

ULS da Arrábida

Setúbal, 2910-446, Portugal

Location

Related Publications (12)

• 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.

  PMID: 40047732 RESULT

• 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.

  PMID: 25151257 RESULT

• 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.

  PMID: 35670896 RESULT

• 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.

  PMID: 32512591 RESULT

• 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.

  PMID: 28584525 RESULT

• 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.

  PMID: 27423053 RESULT

• 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.

  PMID: 28826680 RESULT

• 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.

  PMID: 31295746 RESULT

• 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.

  PMID: 27257916 RESULT

• 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.

  PMID: 25135006 RESULT

• 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.

  PMID: 28003719 RESULT

• 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.

  PMID: 38567898 RESULT

MeSH Terms

Conditions

Fibrosis

Interventions

Bisacodyl

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cresols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 31, 2026
• First Posted: June 25, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): October 30, 2027
• Last Updated: June 25, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

PT (4)