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

Sponsor
Hospital do Divino Espírito Santo de Ponta Delgada
Study ID
NCT07668778
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Bowel Preparation
  • Cirrhosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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
  • 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

Study Details

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.

Key Dates

First listed
Jun 25, 2026
Start date
Aug 1, 2026
Status verified
Jun 2026
Primary completion
Aug 1, 2027
Completion
Oct 30, 2027

Study Design

Enrollment
252 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Regimen A
    2-L split-dose PEG + 1-day low-fibre diet + clear liquids on the afternoon before colonoscopy
  • Experimental: Regimen B
    2-L split-dose PEG + 15 mg bisacodyl + 3-day low fibre diet + clear liquids on the day before colonoscopy

Primary Outcome Measure

Adequate bowel preparation [ Time Frame: Periprocedural ]

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