RecruitingACTRN12613000765729

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


Sponsor

Alfred Hospital

Enrollment

250 participants

Start Date

May 20, 2013

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 99 Yearss

Plain Language Summary

Simplified for easier understanding

This study is comparing two ways of preparing the bowel before a morning colonoscopy. One method uses a low-volume laxative called Picosalax together with a simple white (low-residue) diet the day before. The other method uses currently standard full bowel preparation regimens. Researchers want to find out if the simpler, lower-volume preparation cleans the bowel just as well but is easier for patients to tolerate. You may be eligible if: - You are 18 years or older - You are having an outpatient colonoscopy for a clinically accepted reason (e.g., bowel cancer screening, polyp surveillance, unexplained symptoms, investigation of inflammatory bowel disease) You may NOT be eligible if: - You have suspected bowel perforation, severe colitis, or bowel blockage - You are pregnant or breastfeeding - You have severe kidney failure (eGFR below 30) or severe heart failure - You have phenylketonuria or G6PD deficiency - You have a known allergy to any component of the bowel preparation solutions Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 4

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


Locations(1)

The Alfred - Prahran

VIC, Australia

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ACTRN12613000765729