Effect of Lactulose and/or Polyethylene Glycol Solution for Bowel Preparation for Colonscopy Procedures
Condition: Colonoscopy
Study type: Interventional
Phase: Phase 3

Summary: 
      Colonoscopy is the most useful exam used to evaluate colorectal diseases, like colorectal
      polyps and cancer. The appropriate bowel preparation is indispensable for colonoscopy
      procedures. Polyethylene glycol solution (PEG) is the most frequent laxative medication.
      However, the taste is poor, and patients need to drink a lot of liquids to obtain adequate
      visualization of the mucosal surface. In fact, no laxative has all the characteristics of an
      ideal medication. Lactulose is an osmotic laxative which widely used in cirrhosis and
      constipation patients, and could inhibit bacterial in the colon to increase colon cleanliness
      and prolong the effect time of PEG. Previous study demonstrate PEG combined with lactulose
      has a significant improvement in the quality of bowel preparation compared with PEG alone.
      The present study aim to assess the efficacy of lactulose with or without PEG in bowel
      preparation to improve mucosal visualization, reduced volume of fluid consumed, and
      preparation intolerance.
    

Detailed description: 
      This study will conduct in 5 clinical central. 1000 participants who were scheduled for
      colonoscopy age between 18 and 80 years were enrolled in the study. Exclusion criteria were
      patients with uncontrolled acute or recurrent chronic intestinal infections, with active
      gastrointestinal bleeding or gastrointestinal stricture or intestinal obstruction, with
      severity coronary heart disease or heart failure or renal failure and liver failure or severe
      electrolyte metabolism disorder, with pregnant or lactating or metal diseases or refuse to
      colonoscopy examination. Central stratification and block randomization is achieved via a
      computer-generated random-sequence table by using R software. The participants will be
      assigned into one of four groups at a ratio of 1 : 1, and received a single 3 L dose of
      either PEG or 200ml dose of lactulose, 100ml lactulose combined with 1L PEG, 100ml lactulose
      combined with 2L PEG. The following parameters were then obtained: time of the first
      defecation, defecation frequency, the overall drink liquid volume, the taste of the
      preparation, the tolerance evaluation, the cleansing quality of the bowel preparations and
      adverse reaction.
    

Intervention name(s): 100 ml lactulose combined with 1 L PEG; 100 ml lactulose combined with 2 L PEG; 200 ml lactulose; 3 L Polyethylene glycol solution
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): the participants were instructed to consume 100 ml lactulose combined with 1000 mL of PEG solution; the participants were instructed to consume 100 ml lactulose combined with 2000 mL of PEG solution; the participants were instructed to consume 200 ml lactulose alone; the participants were instructed to consume 3000 mL of PEG solution
Other intervention name(s): lactulose and 1 L PEG group; lactulose and 2 L PEG group; lactulose group; control group; PEG group
Intervention MeSH terms: Lactulose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Polyethylene Glycols; Colonoscopy; Laxatives; Lactulose