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Completed

NCT Number: NCT04474002

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)

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.

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Key information

Conditions

Bowel Preparation Solutions Colonoscopy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Queen Elizabeth Hospital

Kowloon, Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient who mentally capable to consent for participating the trial
  • 18 - 65 years old
  • Scheduled for 1st colonoscopy
  • Elective outpatient colonoscopy

Exclusion criteria

  • Prior colorectal or abdominal-pelvic surgery
  • Inflammatory bowel disease
  • Active bowel condition eg intestinal obstruction
  • Gastrointestinal disorders eg active ulcer, gastric outlet obstruction, gastroparesis and hypomotility syndrome
  • Recent myocardial infarction, congestive heart failure, uncontrolled hypertension
  • Renal dysfunction, hepatic disease
  • Patient on long term tranquilizer, anti-spasmodic, prokinetic, laxative or antidiarrhoeal agents
  • Hypersensitivity to PEG or SPMC solution
  • Pregnant or breastfeeding women
  • Inability to give informed consent

Treatment and study plan

4L Klean Prep®

Drug

Patients allocated to the control group shall mix two sachets of PEG in 2L water. At 6pm the evening before examination, they shall consume 250ml solution every 15mins, and finish in 2hours. At 7am the day of examination, drink another 2L Klean-prep in 2 hours.

1L Klean prep® and 2 sachets Picoprep®

Drug

Patients allocated to the study group shall mix each sachet of Picoprep® in 150ml warm water. The patient shall take the 1st dose at 4pm the day before procedure followed by at least five 250ml drinks of clear fluid before the next dose. The 2nd dose shall be taken approximately 6hrs later and followed by at least three 250ml drinks of clear fluid before bed. On 7am the day of procedure, they shall take 1L PEG in 1 hour.

Primary outcomes

  1. Boston Bowel Preparation Score (BBPS)

    Time frame: Up to 24 weeks

    Adequate bowel preparation is defined as a total BPPS score >/= 6 in which all three segments had score >/=2

Secondary outcomes

  1. Patient tolerability to bowel preparation using Likert scale

    Time frame: Up to 24 weeks

    Patient are requested to fill in questionnaire on the day of colonoscopy. Candidate are asked to rate the frequency of complications between 'none', 'mild', 'moderate' and 'severe'. 'None' being the best outcome and 'severe' being the worst outcome.

  2. Patient compliance towards bowel preparation

    Time frame: Till the day of procedure

    Proportion of patient able to complete the whole bowel preparation as instructed by protocol

  3. Proportion of patient requiring repeat colonoscopy

    Time frame: Up to 24 weeks

    Proportion of incomplete colonoscopy due to inadequate bowel preparation Patient will be attended by physicians and blood taking will be arranged

  4. Incidence of treatment related adverse events

    Time frame: Up to 24 weeks

    Patient will be monitored after colonoscopy for any complications

Sponsors and collaborators

Lead sponsor

Queen Elizabeth Hospital, Hong Kong

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jul 16, 2020
Registry last updated
Aug 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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