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
- Bowel Preparation SolutionsColonoscopy
- Interventions
- Drug: 4L Klean Prep®Drug: 1L Klean prep® and 2 sachets Picoprep®
- Registration Number
- NCT04474002
- Lead Sponsor
- Queen Elizabeth Hospital, Hong Kong
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 158
- Patient who mentally capable to consent for participating the trial
- 18 - 65 years old
- Scheduled for 1st colonoscopy
- Elective outpatient colonoscopy
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 4L Klean Prep® 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 1L Klean prep® and 2 sachets Picoprep® 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
- Primary Outcome Measures
Name Time Method Boston Bowel Preparation Score (BBPS) Up to 24 weeks Adequate bowel preparation is defined as a total BPPS score \>/= 6 in which all three segments had score \>/=2
- Secondary Outcome Measures
Name Time Method Patient tolerability to bowel preparation using Likert scale 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.
Patient compliance towards bowel preparation Till the day of procedure Proportion of patient able to complete the whole bowel preparation as instructed by protocol
Proportion of patient requiring repeat colonoscopy 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
Incidence of treatment related adverse events Up to 24 weeks Patient will be monitored after colonoscopy for any complications
Trial Locations
- Locations (1)
Queen Elizabeth Hospital
🇭🇰Kowloon, Hong Kong