Clinical trial 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)
Official title: 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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Bowel Preparation Solutions
Colonoscopy
Keywords: Polyethylene glycol
Picoprep
Cathartics
Bowel preparation solution
Colonoscopy
Lead sponsor: Queen Elizabeth Hospital, Hong Kong
Sponsor class: OTHER
First posted: 2020-07-16
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Boston Bowel Preparation Score (BBPS)
timeFrame: Up to 24 weeks
Secondary outcomes:
measure: Patient tolerability to bowel preparation using Likert scale
timeFrame: Up to 24 weeks
measure: Patient compliance towards bowel preparation
timeFrame: Till the day of procedure
measure: Proportion of patient requiring repeat colonoscopy
timeFrame: Up to 24 weeks
measure: Incidence of treatment related adverse events
timeFrame: Up to 24 weeks
Other outcomes:
Locations:
city: Kowloon
country: Hong Kong
facility: Queen Elizabeth Hospital
Study officials:
affiliation: Queen Elizabeth Hospital, Hospital Authority
name: Yau Kan Tso
role: PRINCIPAL_INVESTIGATOR
References: