Phase IV clinical trial for evaluating the utility in clinical practice of a predictive system of incorrect colonic preparation in patients derived for ambulatory colonoscopy

INTERVENTION: Trade Name: moviprep Product Name: moviprep Product Code: 68125 Pharmaceutical Form: Coated granules in sachet INN or Proposed INN: MACROGOL 3350 CAS Number: 25322‐68‐3 Current Sponsor code: MACROGOL 3350 Other descriptive name: MACROGOL 3350 Concentration unit: g gram(s) Concentration type: equal Concentration number: 100‐ Trade Name: Casenglicol Product Name: casenglicol Pharmaceutical Form: Coated granules in sachet INN or Proposed INN: MACROGOL 4000 CAS Number: 25322‐68‐3 Current Sponsor code: MACROGOL 4000 Other descriptive name: MACROGOL 4000 Concentration unit: g gram(s) Concentration type: range Concentration number: 14.97‐59.9 Trade Name: dulcolaxo Pharmaceutical Form: Cachet INN or Proposed INN: BISACODYL CAS Number: 603‐50‐9 Current Sponsor code: BISACODYL Other descriptive name: BISACODYL Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5‐ CONDITION: Colonoscopia ambulatoria Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] ‐ Diagnosis [E01] PRIMARY OUTCOME: Main Objective: To compare teh efficacy of two stategies of colonic preparation Primary end point(s): colonic preparation with Boston scale Secondary Objective: 1) Evaluate the utility of a system to allocate strategies for colonic preparation for colonoscopy; 2) To compare the level of tolerance between two types of colonic preparation; 3) To compare the rate of detection of different types of polyps with two types of preparation Timepoint(s) of evaluation of this end point: during coloscopy SECONDARY OUTCOME: Secondary end point(s): tolerance, predisposition to repeat, swelling difficulties, detection of colonic lesions Timepoint(s) of evaluation of this end point: colonoscopy INCLUSION CRITERIA: Patients 18‐85 years old Ambulatory candidates to colonoscopy Informe consent signed Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100