Efficacy, Tolerance and Safety of Split Dose Bowel Preparation for Colonoscopy: 4L Polyethylene Glycol (PEG) Versus 1L Polyethylene Glycol Plus Sodium Picosulfate-magnesium Citrate (SPMC)

Last updated: August 23, 2025
Sponsor: Queen Elizabeth Hospital, Hong Kong
Overall Status: Completed

Phase

4

Condition

Colon Cancer Screening

Treatment

4L Klean Prep®

1L Klean prep® and 2 sachets Picoprep®

Clinical Study ID

NCT04474002
PICO-PEG trial
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

4L split dose PEG is the gold standard for bowel preparation, however it comes with poor tolerability and poor compliance. Combination of PEG with different agent is useful in reducing total volume, improving compliance and tolerance of patient.

The objective of this study is to demonstrate that combination bowel preparation, PEG plus SPMC solution, has similar efficacy and safety profile whereas with a better tolerance when compared to large volume PEG.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patient who mentally capable to consent for participating the trial

  2. 18 - 65 years old

  3. Scheduled for 1st colonoscopy

  4. Elective outpatient colonoscopy

Exclusion

Exclusion Criteria:

  1. Prior colorectal or abdominal-pelvic surgery

  2. Inflammatory bowel disease

  3. Active bowel condition eg intestinal obstruction

  4. Gastrointestinal disorders eg active ulcer, gastric outlet obstruction,gastroparesis and hypomotility syndrome

  5. Recent myocardial infarction, congestive heart failure, uncontrolled hypertension

  6. Renal dysfunction, hepatic disease

  7. Patient on long term tranquilizer, anti-spasmodic, prokinetic, laxative orantidiarrhoeal agents

  8. Hypersensitivity to PEG or SPMC solution

  9. Pregnant or breastfeeding women

  10. Inability to give informed consent

Study Design

Total Participants: 158
Treatment Group(s): 2
Primary Treatment: 4L Klean Prep®
Phase: 4
Study Start date:
December 07, 2020
Estimated Completion Date:
December 31, 2022

Study Description

This is a prospective, randomized, single-center, single-blinded, non-inferiority trial.

Participants with out patient colonoscopy arranged will be included and randomized in a 1:1 ratio to receive either a split dose of 4L PEG + Electrolyte (Klean-prep® ) or 1L Klean-prep® plus 2 sachets SPMC (Picoprep®).

Trained endoscopists will be using the Boston Bowel Preparation Scale (BBPS) to assess the quality of bowel preparation. Patient would also rate the tolerance, compliance and adverse effect by filling the questionnaire before the colonoscopy.

Connect with a study center

  • Queen Elizabeth Hospital

    Kowloon,
    Hong Kong

    Site Not Available

  • Queen Elizabeth Hospital

    Kowloon 1819609,
    Hong Kong

    Site Not Available

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