A Randomized Prospective Trial Comparing Polyethylene Glycol and Sodium Picosulphate With Magnesium Citrate
Condition: Colorectal Cancer; Colon Adenoma
MeSH terms: Adenoma
Study type: Interventional
Phase: Phase 3

Summary: 
      Adequate bowel cleansing is important for a completeness of colonoscopy and detection of
      colon polyps. Inadequate bowel preparation leads to longer duration of colonoscopy and
      obscured mucosal visualization resulting in missed lesions.

      Bowel cleansing agents are simply classified into the large volume, iso-osmotic polyethylene
      glycol (PEG) based solutions or the small volume osmotically active agents, such as sodium
      picosulphate with magnesium citrate (SPMC).

      There are rare reports that compare directly conventional polyethylene glycol (PEG) solution
      and sodium picosulphate with magnesium citrate (SPMC) for bowel preparation in korea.

      The aim of this study is to compare the efficacy, safety, and tolerability of different
      regimens of SPMC and PEG solution.
    

Detailed description: 
      1. Study design: endoscopist-blinded, prospective, randomized controlled trial

        2. Subjects

             1. Entry criteria: Male or female patients, aged between18 and 75 years undergoing
                elective outpatient colonoscopy were eligible for the study.

             2. Exclusion criteria:

           gastrointestinal obstruction or perforation, toxic megacolon, severe uncontrolled
           inflammatory bowel disease, previous colorectal resection, congestive heart failure,
           recent acute myocardial infarction or unstable angina, uncontrolled arterial
           hypertension, renal insufficiency with glomerular filtration rate < 60 ml/minute/1.73
           m2, liver cirrhosis or ascites, pregnancy, lactation, and history of hypersensitivity to
           any bowel cleansing agents.

        3. Sampling design: Consecutive recruitment of consenting patients

        4. Variables Predictor

             1. group 1 (same day PEG) received 4 L of PEG at 6 hours before procedure on the day
                of the colonoscopy

             2. group 2 (split PEG) received 2 L of PEG at 6:00 p.m the evening before colonoscopy
                and 2 L of PEG at 4-6 hours before procedure

             3. group 3 (SPMC 2) received one sachet of SPMC at 6 p.m the evening before
                colonoscopy and another sachet of SPMC at 4-6 hours before procedure;

             4. group 4 (SPMC 3) received one sachet of SPMC at 6 p.m and the other sachet at 9 p.m
                the evening before colonoscopy and another sachet at 4-6 hours before procedure.

        5. Primary Outcome: Quality of bowel preparation (Ottawa scale)

        6. Secondary Outcome: Tolerability, palatability, side effect of the cleansing agents
    

Intervention name(s): Polyethylene glycol; Polyethylene glycol; Sodium picosulphate with magnesium citrate; Sodium picosulphate with magnesium citrate
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): -group 1 (same day PEG) received 4 L of PEG at 6 hours before procedure on the day of the colonoscopy; -group 2 (split PEG, N=50) received 2 L of PEG at 6:00 p.m the evening before colonoscopy and 2 L of PEG at 4-6 hours before procedure; -group 3 (SPMC 2) received one sachet of SPMC at 6 p.m the evening before colonoscopy and another sachet of SPMC at 4-6 hours before procedure; -group 4 (SPMC 3) received one sachet of SPMC at 6 p.m and the other sachet at 9 p.m the evening before colonoscopy and another sachet at 4-6 hours before procedure.
Other intervention name(s): Colyte(Taejoon Pharmaceuticals, Seoul, Korea); Colyte(Taejoon Pharmaceuticals, Seoul, Korea); Picolight(Pharmbio korea, Seoul, Korea); Picolight(Pharmbio korea, Seoul, Korea)
Intervention MeSH terms: Magnesium citrate; Picosulfate sodium; Citric Acid; Sodium Citrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Supportive Care
Keywords: Bowel preparation; Polyethylene glycol; Sodium picosulphate