Comparing to see if picosalax in combination with low residue diet is as good for bowel cleanliness and better tolerated than current bowel preparations used for morning colonoscopies.

A Single-blind, randomised non inferiority study of the effectiveness and tolerability of picosalax and low residue diet compared to standard bowel preparation prior to morning colonoscopy

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000765729

Enrollment

250

Registered

2013-07-09

Start date

2013-05-20

Completion date

2014-02-09

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

Primary purpose of the study is to examine if a low volume bowel preparation in conjunction with a white diet will have the same cleansing effect as current bowel preparations.

Interventions

Picosalax bowel preparation in combination to low residue diet Picosalax Two sachets, each to be mixed in 250ml of water *One to be taken 9pm the day prior to the colonoscopy *One to be taken 4am on the day of the colonoscopy The low residue diet is to start 2 days prior to the colonoscopy and cease when bowel preparation starts * Examples include : *Milk (regular, low fat, skim), water, lemonade, soda or mineral water, clear (not coloured) Gatorade or other sports drinks *Regular white bread/toast, rice bubbles, white rice, regular pasta, potatoes (peeled), rice noodles, plain rice crackers, white flour, sugar *Eggs, Chicken breast (no skin), white fish fillet (no skin) *Plain cream cheese, cheddar cheese, ricotta, fetta, cottage, parmesan or mozzarella cheese, white sauce *White coloured yoghurt (no added fruit or inulin), mayonnaise, cream, sour cream, butter and margarine, oil for cooking *White chocolate, vanilla ice cream, lemonade icypole, clear jelly, custard, “milk bottles”(confectionery Adherence will be assessed through a food diary that the patient fills up during the two days prior to the colonoscopy

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Diagnosis

Masking

Blinded (masking used) (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to 99 Years

Healthy volunteers

Inclusion criteria

Consenting adult patients (aged 18 years and greater) undergoing outpatient colonoscopy for clinically accepted indications. Clinically accepted indications generally include but are not restricted to iron deficiency anaemia, surveillance of bowel polyps, colorectal cancer screening, assessment of symptoms such as abdominal pain, diarrhoea and constipation, assessment or investigation of inflammatory bowel disease.

Exclusion criteria

Exclusion criteria are conditions generally considered as exclusions to colonoscopy in normal clinical practice. They are suspected bowel perforation, gastric outlet obstruction, toxic megacolon, severe colitis, and pregnancy or lactation. For additional safety, will also exclude patients with the relative contraindications of significant renal failure (eGFR<30) significant heart failure (New York Heart Association Class III or IV). Prep-Kit C is contraindicated in individuals with phenylketonuria, due to the presence of aspartame and patients with Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency given it contains ascorbic acid (vitamin C) which is an oxidant. Any person with a known hypersensitivity to a constituent of Picoprep, Glycoprep or Picosalax will also be excluded.

Outcome results