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)

Queen Elizabeth Hospital, Hong Kong

Status and phase: Completed; Phase 4

Conditions: Bowel Preparation Solutions; Colonoscopy

Treatments: Drug: 1L Klean prep® and 2 sachets Picoprep®; Drug: 4L Klean Prep®

Study type: Interventional

Funder types: Other

Identifiers

NCT04474002

PICO-PEG trial

Details and patient eligibility

About

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.

Full 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.

Enrollment: 158 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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 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 or antidiarrhoeal agents
8. Hypersensitivity to PEG or SPMC solution
9. Pregnant or breastfeeding women
10. Inability to give informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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158 participants in 2 patient groups

4L Klean Prep®

Active Comparator group

Description:

Drug: 59g polyethylene glycol, 5.685g Na sulphate, 1.685g Na bicarbonate, 1.465g NaCl, 0.7425g KCl and aspartame 0.0494g

Treatment:

Drug: 4L Klean Prep®

1L Klean prep® and 2 sachets Picoprep®

Experimental group

Description:

Drug: 59g polyethylene glycol, 5.685g Na sulphate, 1.685g Na bicarbonate, 1.465g NaCl, 0.7425g KCl, aspartame 0.0494g, sodium picosulfate 0.01g, magnesium oxide 3.5g, citric acid 12.0g

Treatment:

Drug: 1L Klean prep® and 2 sachets Picoprep®