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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital do Divino Espírito Santo de Ponta Delgada

About this trial

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.

Eligibility criteria

Qualifiers

Established diagnosis of cirrhosis, scheduled for elective outpatient total colonoscopy

Age ≥ 18 years

Ability to follow verbal and written instructions in Portuguese

Disqualifiers

Urgent procedures

Colonoscopies not intended to reach the caecum

History of any colonic surgery

Absolute contraindication to bowel preparation or colonoscopy

Trial design

Treatments tested in this trial

  • 2-L PEG plus bisacodyl plus 3-day low fibre diet
  • 2-L PEG plus 1-day low fibre diet

Treatment groups

252 Participants
are divided into 2 treatment groups