Efficacy, Safety and Tolerability of Split-dose of PEG Compared With NaP Solution for Colonoscopy Preparation: A Randomized, Controlled Trial
Condition: Bowel Preparation, Efficacy, Tolerability, Safety
Study type: Interventional
Phase: Phase 3

Summary: 
      : In several studies comparing of sodium phosphate solutions versus PEG, both regimen had
      similar efficacy of bowel cleansing and sodium phosphate solutions are more acceptable to
      patients because patient are required to consume smaller volume. But sodium phosphate
      solutions are associated with fluid and electrolyte disturbances, so use of sodium phosphate
      solution in routine medical check-up of outpatients is problematic. PEG can provide a rapid
      peroral approach to colon lavage without causing fluid and electrolyte disturbance. However,
      the need to ingest a large volume of fluid reduces patient compliance, and results in
      suboptimal bowel preparation. In order to overcome this disadvantage, several studies proved
      that split dose of PEG regimens were better quality preparation and more acceptable than
      single dose regimens. In Korea, need for outpatient or screening colonoscopy without
      laboratory test is increasing and split dose of PEG is used more frequently than other
      country in bowel preparation because of safety. But, superiority of split dose of PEG to
      sodium phosphate solution has not been demonstrated. The study was not yet existed about
      comparison of split dose PEG solution with sodium phosphate solution for bowel cleansing and
      tolerability in colonoscopy preparation. To use split dose of PEG in bowel preparation with
      medical evidence, we want to demonstrate split dose bowel preparation with PEG compared to
      sodium phosphate solutions provide a better colon cleansing efficacy and similar
      tolerability.
    

Detailed description: 
      Study design: Investigator-blinded, prospective, randomized controlled trial

      Subjects

        1. Entry criteria: Adult outpatients(at least 18 years of age, under 65 years) who undergo
           scheduled colonoscopy for screening, cancer surveillance or want procedure with/without
           non-specific gastrointestinal symptoms.

        2. Exclusion criteria:

      age under 18 years, elderly patients(>65 yrs), pregnancy, breast feeding, patient with bowel
      obstruction, and other structural intestinal disorders, gut hypomotility(chronic
      constipation(< 2 bowel movement/week for 1yr), hypomotility syndrome, megacolon, idiopathic
      pseudoobstruction), renal failure, congestive heart failure, liver failure, pre-existing
      electrolyte disturbance(hypercalcemia, hyperphosphatemia); refusal of consent to participate
      in the study.

      Sampling design: Consecutive recruitment of consenting patients

      Variables Predictor: split dose of PEG and sodium phosphate Primary Outcome: Quality of bowel
      preparation (Ottawa scale) Secondary Outcome: Tolerability (preparation completion, side
      effect) Confounding variables: age, gender, BMI, experience of colonoscopy, surgical history,
      bowel movement, comorbidity, indication, presence of GI symptoms, medication

      Statistical issues

      Hypothesis: Split dose bowel preparation with PEG will provide a better quality preparation
      and similar tolerability than that with sodium phosphate for morning colonoscopy.

      Sample size.: Improving rate 20% in bowel cleansing efficacy(Ottawa scale), study power 80%,
      alpha-error(level of significance, P-value) 5%, mean value scale=5, effect size 1, SD=2.5->
      sample size= 100/100
    

Intervention name(s): Polyethylene glycol; Sodium phosphate(NaP) solution
Intervention type(s): Drug; Drug
Intervention description(s): Group 1 (split-dose PEG regimen; Colyte, Taejoon Pharmaceuticals, Seoul, Korea; 236g PEG, 22.74g Na2SO4, 6.74g NaHCO3, 5.86g NaCl, and 2.97g KCl) ingested 2 liters of PEG at 6 PM on the day before the procedure and the remaining 2 liters in the early morning at least 2 hours prior to the procedure. Patients were instructed to take PEG 250 ml every ten minutes. Group 2 (NaP regimen; Solin Oral, Korea Pharma., Seoul, Korea; 48g NaH2PO4 monosodium phosphate, 18g Na2HPO4 disodium phosphate) ingested 45ml NaP solution at 6 PM on the day before the procedure and remaining 45ml of NaP solution, separated temporally by minimum of 10 to 12 hours, at least 2 hours prior to the colonoscopy on the day of the procedure.; Group 2 (NaP regimen; Solin Oral, Korea Pharma., Seoul, Korea; 48g NaH2PO4 monosodium phosphate, 18g Na2HPO4 disodium phosphate) ingested 45ml NaP solution at 6 PM on the day before the procedure and remaining 45ml of NaP solution, separated temporally by minimum of 10 to 12 hours, at least 2 hours prior to the colonoscopy on the day of the procedure. Patients taking NaP solution were instructed to drink a minimum 1L of clear liquids during the evening on the day before the procedure and were encouraged to consume additional clear liquids.
Other intervention name(s): Colyte(Taejoon Pharmaceuticals, Seoul, Korea); Solin Oral (Korea Pharma., Seoul, Korea)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Diagnostic
Keywords: Polyethylene Glycol, Sodium Phosphate, Bowel preparation, Efficacy