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Randomised Controlled Trial of Evening Before Bowel Preparation With Loperamide Versus Split Bowel Preparation in Colonoscopy Patients

Randomised Controlled Trial of Evening Before Bowel Preparation With Loperamide Versus Split Bowel Preparation in Colonoscopy Patients - A Non-inferiority Study

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618001388202
Enrollment
90
Registered
2018-08-17
Start date
2018-11-01
Completion date
2020-07-01
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The quality of bowel preparation (cleanliness of the colon) is important in determining the effectiveness of colonoscopy. Superior cleansing improves the quality of the colonoscopy. Bowel preparation regimes can be administered as either split dose (where bowel preparation regime is divided between the day before and day of colonoscopy) or evening before with loperamide (whole regime is given the evening before colonoscopy and a drug named loperamide is given to help keep the cleansed bowel clean). This study is aimed at identifying which regime would produce a cleaner bowel for colonoscopy. Split dose bowel preparation is gold standard and used around the world. Loperamide is a drug that has been shown to prevent further movement of bowel contents from the upper bowel into the colon. Hence it is possible the addition of loperamide to an evening before regime (not gold standard) will produce a similar if not better outcome than the gold standard (split dose) regime.

Interventions

Split Dose Prep (Prep 1): • 1 Picosalax sachet mixed with 150ml warm water. Administer at 1900hrs day before procedure followed by at least 5 x 250ml drinks of clear liquids spread over several hours • Bisacodyl tablets 5mg x3 (total 15mg). Administer at 1900hrs day before procedure. • 1 Picosalax sachet mixed with 150ml warm water. Administer at 0500hrs day before procedure followed by at least 2x250ml drinks of clear liquids until 0600. Adherence to this process will be monitored with a part

Split Dose Prep (Prep 1): • 1 Picosalax sachet mixed with 150ml warm water. Administer at 1900hrs day before procedure followed by at least 5 x 250ml drinks of clear liquids spread over several hours • Bisacodyl tablets 5mg x3 (total 15mg). Administer at 1900hrs day before procedure. • 1 Picosalax sachet mixed with 150ml warm water. Administer at 0500hrs day before procedure followed by at least 2x250ml drinks of clear liquids until 0600. Adherence to this process will be monitored with a participant diary which will be reviewed upon arrival for a colonoscopy. This diary will ask patients to document the medication, time and dose taken of the prescribed regime.

Sponsors

Dr Sameer Memon
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

Patients referred for colonoscopy on a specific single endoscopist nurse led sedation endoscopy list

Exclusion criteria

1. Patients with previous bowel resection. 2. Patients with previous incomplete colonoscopy. 3. Patients requiring extended bowel preparation (history of constipation, previous incomplete prep). 4. Patients requiring inpatient bowel preparation. 5. Patients <18 years old or >75 years old. 6. Patients with a history of hypersensitivity or allergy to Loperamide or Picosalax or Bisacodyl. 7. Patients with active bowel inflammation. 8. Patients pregnant or breastfeeding

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026