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Not yet recruitingPhase 3

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

Key facts

Who runs it
Hospital do Divino Espírito Santo de Ponta Delgada
Where
Portugal4 sites in 1 countryChoose a country to see its sites
Trial code
Status
Not yet recruiting
Phase
Phase 3
People taking part
252 people, planned
Started
1 Aug 2026
Expected to end
30 Oct 2027
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • 2-L PEG plus bisacodyl plus 3-day low fibre diet
  • 2-L PEG plus 1-day low fibre diet
Record updated
25 June 2026

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 11 criteriaShow less

Who can take part

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

Who cannot take part

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

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

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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.

The 2 groups in the trial

  • Regimen AExisting treatment, for comparison

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

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

  • Regimen BTreatment being tested

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

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

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Evaluation of a Modified Bowel Preparation Regimen in Cirrhotic Patients Undergoing Colonoscopy: a Multicentre Randomized Controlled Trial
Record updated
25 June 2026