None listed
Conditions
Brief summary
The study aim is to compare the efficacy and patient tolerability of PLENVU®, a new low volume bowel preparation which has demonstrated safety and overall bowel cleansing success in three European and American trials, with the current standard bowel preparation at Alfred for patients undergoing colonoscopy for clinically accepted reasons, which uses Prepkit-C®. PLENVU is a registered trademark of the Norgine Group of companies. Who is it for? You may be eligible for this study if you are aged 18 or over and undergoing an outpatient colonoscopy. Study details Participants in this study will be randomly assigned (by chance) to receive one of two bowel preparation methods, either PLENVU or Prepkit-C. Participants will use the kits before their procedure according to the instructions provided by Alfred Hospital. The effectiveness of the two kits in preparing the bowels for colonoscopy will be compared using two validated scoring methods to assess quality of bowel preparation for colonoscopy. Participants will be asked to complete a brief (10 minute) questionnaire on the day of the colonoscopy, in the waiting area, ahead of going through for their procedure. The questionnaire will ask about their experience in taking the bowel preparation they received. The study will aim to determine whether PLENVU leads to a similar quality of bowel cleanliness as Prepkit-C and also whether patients' tolerance, acceptance and compliance is similar between the two bowel preparations.
Interventions
PLENVU is a novel, low volume (1L) polyethylene glycol based bowel preparation that has demonstrated a good safety profile and an overall bowel cleansing success in two European and one American phase 3 trials,.
Consenting patients who are to undergo routine colonoscopy will be randomised to receive PLENVU or the standard bowel preparation at Alfred Hospital using Prepkit-C.
Participants will be provided instruction sheets for taking the preparation to which they are allocated. To assess accept
PLENVU is a novel, low volume (1L) polyethylene glycol based bowel preparation that has demonstrated a good safety profile and an overall bowel cleansing success in two European and one American phase 3 trials,. Consenting patients who are to undergo routine colonoscopy will be randomised to receive PLENVU or the standard bowel preparation at Alfred Hospital using Prepkit-C. Participants will be provided instruction sheets for taking the preparation to which they are allocated. To assess acceptance and tolerance, participants will be asked to complete a questionnaire on the day of and ahead of the procedure.
Sponsors
The Alfred Hospital
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 No maximum
Healthy volunteers
No
Inclusion criteria
Consenting adult patients (minimum age 18 years) 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 such as suspected bowel perforation, gastric outlet obstruction, toxic megacolon, severe colitis, pregnancy or lactation. For additional safety, we will also exclude patients with relative contraindications such as significant renal failure (eGFR <30) and significant heart failure (New York Heart Association Class III or IV). We will exclude patients with phenylketonuria, due to the presence of aspartame and patients with Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency given that these bowel preparation regimens contain ascorbic acid (vitamin C) which is an oxidant. Patients with a known hypersensitivity to a constituent of Prepkit-C® or PLENVU® will also be excluded. Patients who require an extended bowel preparation for type I diabetes mellitus, cystic fibrosis or due to having had a previous colonoscopy with inadequate bowel preparation. We will also exclude patients with previous major colonic resection as this will impact on the bowel cleaning scoring system that we are using for this study.
Outcome results
None listed