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)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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)

Conditions
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Colonoscopy, Bowel Preparation Solutions

Intervention / Treatment
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* Drug: 4L Klean Prep®
* Drug: 1L Klean prep® and 2 sachets Picoprep®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 4L Klean Prep®<br>Drug: 59g polyethylene glycol, 5.685g Na sulphate, 1.685g Na bicarbonate, 1.465g NaCl, 0.7425g KCl and aspartame 0.0494g | Drug: 4L Klean Prep®<br>* 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.<br>|
| Experimental: 1L Klean prep® and 2 sachets Picoprep®<br>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 | Drug: 1L Klean prep® and 2 sachets Picoprep®<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Boston Bowel Preparation Score (BBPS) | Adequate bowel preparation is defined as a total BPPS score >/= 6 in which all three segments had score >/=2 | Up to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient tolerability to bowel preparation using Likert scale | 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. | Up to 24 weeks | 
| Patient compliance towards bowel preparation | Proportion of patient able to complete the whole bowel preparation as instructed by protocol | Till the day of procedure | 
| Proportion of patient requiring repeat colonoscopy | Proportion of incomplete colonoscopy due to inadequate bowel preparation Patient will be attended by physicians and blood taking will be arranged | Up to 24 weeks | 
| Incidence of treatment related adverse events | Patient will be monitored after colonoscopy for any complications | Up to 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Polyethylene glycol, Picoprep, Cathartics, Bowel preparation solution, Colonoscopy