Evaluation of a Modified Bowel Preparation Regimen in Cirrhotic Patients Undergoing Colonoscopy: a Multicentre Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 252
- 试验地点
- 4
研究概览
简要总结
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.
详细描述
BACKGROUND AND RATIONALE
Optimal diagnostic yield in colonoscopy is critically dependent on the quality of bowel preparation. Inadequate bowel preparation, observed in up to 25% of colonoscopies, adversely impacts procedural performance and diagnostic accuracy, with significantly reduced detection rates of adenomas and advanced adenomas, increased risk of undetected colorectal cancer, longer procedure times, and need for repeat colonoscopy.
Cirrhosis has been consistently identified as an independent predictor of inadequate bowel preparation, with studies reporting suboptimal cleansing in 29.8-49% of cirrhotic patients undergoing colonoscopy. Proposed mechanisms include impaired gastrointestinal motility related to autonomic dysfunction, metabolic derangements, small intestinal bacterial overgrowth, and increased bacterial translocation, serving as a potential trigger for several complications associated with chronic liver disease.
Suboptimal bowel preparation may be particularly detrimental in patients with cirrhosis as chronic liver diseases may place patients at increased risk of colorectal cancer, making adequate bowel preparation essential to maximize the efficacy of screening with colonoscopy.
Studies that have reported on modified strategies for individuals with previous inadequate bowel preparation include prolonged low-fibre diets, the addition of promotility agents and/or the use of high-volume bowel preparation regimens. Recently, the US Multi-Society Task Force (USMSTF) developed a consensus statement addressing bowel preparation regimens for individuals at high risk for inadequate bowel preparation, suggesting a split-dose high volume PEG formulation plus 15 mg bisacodyl the afternoon before the colonoscopy, along with a low-fibre diet 2 to 3 days before colonoscopy, changing to clear-liquid diet the day before colonoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Established diagnosis of cirrhosis, scheduled for elective outpatient total colonoscopy
- •Age ≥ 18 years
- •Ability to follow verbal and written instructions in Portuguese
排除标准
- •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
研究者
Nadine Amaral
Principal Investigator
Hospital do Divino Espírito Santo de Ponta Delgada