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

Starting soon · Phase 3

Conditions studied: Cirrhosis, Bowel Preparation

In brief

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 facts

Study ID

NCT07668778

Run by

Hospital do Divino Espírito Santo de Ponta Delgada

People needed

252

Starts

2026-08-01

Expected to finish

2027-10-30

Last updated by the study team

2026-06-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Hospital Central do Funchal, SESARAM — Funchal, Madeira, Portugal
• Hospital do Divino Espírito Santo de Ponta Delgada — Ponta Delgada, São Miguel, Portugal
• ULS de Coimbra — Coimbra, Portugal
• ULS da Arrábida — Setúbal, Portugal

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.