preparation in patients with inflammatory bowel disease who will undergo an endoscopy
Conditions
Interventions
Trade Name: Moviprep Sabor Naranja
Pharmaceutical Form: Powder for oral solution
INN or Proposed INN: MACROGOL 3350
CAS Number: 25322-68-3
Sponsors
Hospital Universitario La Paz
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients between 18 and 90 years old. - Patients with established diagnosis of Inflammatory Bowel Disease to whom a complete colonoscopy is requested for diagnostic purposes. 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 24 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: - Pregnant women. - Previous colonic resection surgeries. - Endoscopies performed for therapeutic purposes (eg, polyps resection already objectified in previous studies). - Poor preparation in recent endoscopy (12 months prior). - Patients not trained to understand the nature of the study, the procedures to follow or who is not authorized to sign an informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the degree of preparation with Movipreep vs Citrafleet in fractionated doses in patients with IBD.;Primary end point(s): Boston scale. ANNEX III.;Timepoint(s) of evaluation of this end point: at the end of endoscopy; Secondary Objective: 1. To assess the tolerability and safety of the fractionated dose preparation with Moviprep vs Citrafleet in our center in patients with IBD. 2. Evaluate the satisfaction of the patient with IBD with Moviprep vs Citrafleet in a fractionated dose. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Patient Satisfaction Questionnaire prior to the test and if the preparation has been completed completely - Analytical with hydroelectrolytic parameters - Questionnaire per week of late complications. ;Timepoint(s) of evaluation of this end point: before the completion of the endoscopy and a week later | — |
Countries
Spain
Contacts
Public ContactElena
Hospital La Paz. UCICEC
Outcome results
None listed