A Multi-centre Study Comparing the Polyp Detection Rate of Two Different Types of Bowel Preparation: a 2-litre Solution (MOVIPREP®) Versus a Hyperosmotic and Stimulant Combined Low Volume Bowel Preparation (Sodium Picosulfate and Magnesium Citrate)

Study Overview
=================
Brief Summary
-----------------
To compare the polyp and adenoma detection rate of MOVIPREP versus an oral Sodium Picosulfate/Magnesium Citrate solution.

Official Title
-----------------
A Multi-centre, Randomised, Investigator-blinded Study Comparing the Polyp Detection Rate of Two Different Types of Bowel Preparation: a 2-litre Solution (MOVIPREP®) Versus a Hyperosmotic and Stimulant Combined Low Volume Bowel Preparation (Sodium Picosulfate and Magnesium Citrate)

Conditions
-----------------
Colorectal Cancer

Intervention / Treatment
-----------------
* Drug: MOVIPREP
* Drug: CitraFleet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient's written informed consent must be obtained prior to inclusion. Male or female outpatients or inpatients aged 40 to 80 years with an indication for complete colonoscopy. Willing to undergo a colonoscopy for diagnostic or surveillance purposes Patients with a known personal of familial risk of colon neoplasia, willing to undergo a screening colonoscopy Willing, able and competent to complete the entire procedure and to comply with study instructions. Females of childbearing potential must employ an adequate method of contraception. Exclusion Criteria: History of gastric emptying disorders. History of ileus, toxic megacolon, gastrointestinal obstruction and colonic perforation. History of phenylketonuria. Known glucose-6-phosphate dehydrogenase deficiency. Known hypersensitivity to macrogol 3350, sodium sulphate or ascorbic acid/sodium ascorbate. History of colonic resection. Requirement for permanent medication and associated stable serum concentrations (e.g. neuroleptic drugs). Presence of congestive heart failure (NYHA III + IV). Acute life-threatening cardiovascular disease. Documented history of severe renal insufficiency (creatinine clearance <30 ml/min). Other contraindication described in the summary of product characteristics (SmPC) of either preparation. Patient has a condition, clinically significant laboratory results, or is in a situation which, in the investigator's opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly. Application of any unlicensed medication within the previous 3 months or participation in any other research study in the last 3 months. Females who are pregnant, nursing or planning a pregnancy. Patients who, in the opinion of the investigator, may not be compliant with the study requirements. Previous participation in this clinical study.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CitraFleet<br>Administration of CitraFleet | Drug: CitraFleet<br> <br> |
| Experimental: MOVIPREP<br>Administration of MOVIPREP | Drug: MOVIPREP<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Polyp detection rate | Polyp detection rate defined as number of patients with at least one polyp or flat lesion as recorded by the endoscopist | At colonoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adenoma Detection Rate (ADR) | ADR, (including flat lesions) defined as number of patients with at least one adenoma as recorded by the pathologist in relation to the total analysis population | At the Colonoscopy | 
| ADR and PDR by location | ADR and PDR by location: left sided (rectum, colon sigmoideum, colon decendens, left half of colon transversum right-sided (right half of colon transversum, colon ascendens, caecum | at the colonoscopy | 
| Cancer detection rate | Cancer detection rate, defined as number of patients with at least one malignancy in relation to the total analysis population | at the colonoscopy | 
| Flat lesion only detection rate | Flat lesion only detection of the patients | at the colonoscopy | 
| Advanced risk lesion detection rate | Advanced risk lesion detection rate (lesions >1 cm, low grade and/or villous | at the colonoscopy | 
| Colonoscopy completion rate | The rate of colonoscopy completion | at the colonoscopy | 
| Colon cleansing quality | Colon cleansing quality as reported by the gastroenterologist, according to the Harefield Cleansing Scale© | at the colonoscopy | 
| Acceptability and tolerability of medication using patient questionnaires | The acceptability and tolerability of the study medication taken by the patients throughout the study using specified patient questionnaires | Throughout the study |