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.
Established diagnosis of cirrhosis, scheduled for elective outpatient total colonoscopy
Age ≥ 18 years
Ability to follow verbal and written instructions in Portuguese
Urgent procedures
Colonoscopies not intended to reach the caecum
History of any colonic surgery
Absolute contraindication to bowel preparation or colonoscopy
Parallel
2-L PEG plus bisacodyl plus 3-day low fibre diet
Drug2-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
2-L PEG plus 1-day low fibre diet
Drug2-L split-dose polyethylene glycol bowel preparation combined with a 1-day low-fibre diet and clear liquids the afternoon before colonoscopy
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.
Total Boston Bowel Preparation Scale score
Mean total Boston Bowel Preparation Scale (BBPS) score. The BBPS ranges from 0 to 9, with higher scores indicating better bowel cleansing.
Polyp detection rate
Proportion of colonoscopies in which at least one colorectal polyp is detected.
Adenoma detection rate
Proportion of colonoscopies in which at least one histologically confirmed adenoma is detected.
Advanced adenoma detection rate
Proportion of colonoscopies with detection of at least one advanced adenoma, defined as adenoma ≥ 10 mm, villous histology or high-grade dysplasia.
Adverse events
Incidence of adverse events related to bowel preparation or colonoscopy. Expected non-serious symtoms related to bowel preparation include: * nausea; * vomiting; * abdominal fullness; * bloating; * abdominal cramps/pain; * diarrhea; Adverse events wil be classified according to: * severity (mild, moderate, severe); * causality (unrelated, possible, probable, highly probable); * outcome (resolved, resolving, unresolved, death, unknown). Serious adverse events include: * hepatic decompensation with severe hepatic encephalopathy; * clinically significant electrolyte disturbances; * bowel preparation-related hospitalization; * procedure-related complications.
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