This is a study to test the non-inferiority of bowel cleansing with 100 g Mannitol against standard Plenvu® same-day dosing regimen. The 50% of the subjects will receive Mannitol, while the remaining part will receive Plenvu®.
Not provided
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
412
Participants should self administer the preparation within 45 minutes, dissolving 100g of powder in 1L of water
Self administration of the same day preparation according to the on lable instruction for use. The first dose consists in dissolving Dose 1 in 500ml of water, followed by another 500ml of water, all within 1 hour. After a 1 hour wait from the end of the first dose, the participant should self administer the Dose 2 consisting in dissolving one sachetA and one sachetB in 500ml of water, followed by another 500ml of water; all within 1 hour.
Hopital Erasme
Anderlecht, Belgium
RECRUITINGProportion of subjects with adequate bowel cleansing defined by the Boston Bowel Preparation Scale (BBPS) total score
Proportion of subjects with adequate bowel cleansing, defined as BBPS total score ≥ 6, with a score for each of the three colon segments (right; transverse, including flexures; and left, including sigmoid and rectum) ≥ 2 after standard washing and air or CO2 insufflation for luminal distension.
Time frame: During colonoscopy (visit4), maximum 28 days after signing the informed consent form)
Adenoma detection rate
Adenoma detection rate, defined as the proportion of subjects ≥ 50 years old undergoing colonoscopy who have at least one lesion detected.
Time frame: During colonoscopy (visit4), maximum 28 days after signing the informed consent form)
Caecal intubation rate
Caecal intubation rate, defined as the proportion of subjects undergoing colonoscopy with ileocecal junction appendiceal orifice visible to the endoscopist.
Time frame: During colonoscopy (visit4), maximum 28 days after signing the informed consent form)
Proportion of subjects undergoing colonoscopy who have to repeat the procedure
Proportion of subjects undergoing colonoscopy who have to repeat the procedure due to inadequate intestinal cleansing to resolve, at the discretion of the endoscopist, the clinical issue underlying the request for colonoscopy.
Time frame: During colonoscopy (visit4), maximum 28 days after signing the informed consent form)
Proportion of subjects undergoing colonoscopy with presence of colonic bubbles
Proportion of subjects undergoing colonoscopy with presence of colonic bubbles assessed through the Colon Endoscopic Bubble Scale (CEBuS).
Time frame: During colonoscopy (visit4), maximum 28 days after signing the informed consent form)
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Katholieke Universiteit te Leuven
Leuven, Belgium
RECRUITINGAlgemeen Ziekenhuis Damiaan Oostende
Ostend, Belgium
RECRUITINGAzienda Unita Sanitaria Locale Di Modena - Ospedale Ramazzini di Carpi
Carpi, Modena, Italy
RECRUITINGCentro Di Riferimento Oncologico Di Aviano
Aviano, Pordenone, Italy
RECRUITINGIRCCS Ospedale Sacro Cuore Don Calabria
Negrar, Verona, Italy
RECRUITINGAzienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Bologna, Italy
RECRUITINGFondazione Poliambulanza
Brescia, Italy
RECRUITINGCongregazione Delle Suore Infermiere Dell'Addolorata - Ospedale Valduce
Como, Italy
RECRUITINGFondazione IRCCS Cà Granda Ospedale Policlinico
Milan, Italy
RECRUITING...and 8 more locations