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)
NCT ID: NCT04474002
Last Updated: 2025-08-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
158 participants
INTERVENTIONAL
2020-12-07
2022-12-31
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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4L Klean Prep®
Drug: 59g polyethylene glycol, 5.685g Na sulphate, 1.685g Na bicarbonate, 1.465g NaCl, 0.7425g KCl and aspartame 0.0494g
4L Klean Prep®
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: 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
1L Klean prep® and 2 sachets Picoprep®
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.
Interventions
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4L Klean Prep®
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®
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.
Eligibility Criteria
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Inclusion Criteria
2. 18 - 65 years old
3. Scheduled for 1st colonoscopy
4. Elective outpatient colonoscopy
Exclusion Criteria
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
18 Years
65 Years
ALL
Yes
Sponsors
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Queen Elizabeth Hospital, Hong Kong
OTHER
Responsible Party
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Tso Yau Kan
Resident
Principal Investigators
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Yau Kan Tso
Role: PRINCIPAL_INVESTIGATOR
Queen Elizabeth Hospital, Hospital Authority
Locations
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Queen Elizabeth Hospital
Kowloon, , Hong Kong
Countries
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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PICO-PEG trial
Identifier Type: -
Identifier Source: org_study_id
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