ABSTRACT: Interventions: Clinical, single-blind, randomized, controlled trial. Based on an estimated 30% difference between groups, a sample was calculated in 276 patients, divided into 3 groups (1: 1: 1).
Boston scale was used to assess preparation adequacy, with a score> 2 in each colon follow-up, obtaining an overall maximum score of 9 points.
The intestinal preparation used were:
Bisacodil 10mg the day before the exam and SG5% 1000ml intravenous on the day of the exam was applied to all patients.
Patients were randomized in 3 groups with different preparation solutions, per oral intake:
Group 1: Lactitol 400ml + 300ml of citrus juice,
Group 2: Mannitol20% 500ml + 200ml of citrus juice
Group 3: PEG-macrogol 20 sachets (citrus flavor) + 750ml of water.
After using the solution, in a day hospital scheme, laboratory evaluations and tolerability research were carried out. Experienced endoscopists, blinded to the type of preparation, performed the exam, at least 4 hours after the last dose of the medication. They performed the Boston scale evaluation, as described in the literature, assigning scores to colonic segments. Patients are sedated by anesthesiologists, according to the local protocol of the service.
After anesthetic recovery, patients were discharged from the hospital.
Before and after ingesting the solutions, the serum level of electrolytes (sodium and potassium) was measured; in addition, a scale to assess palatability was applied after completion of preparation. Adverse events were cataloged and classified as mild, moderate or severe.;Drug;A03.556.124.526
Primary outcome(s): It is expected that the lactitol oral solution will be more effective than 20% mannitol and PEG-macrogol solutions for colon cleansing in patients who will undergo a colonoscopy exam.
The suitability will be assessed by the Boston scale score, considering the score greater than 2 points obtained in each intestinal segment to be adequate.
Study Design: Treatment trial, randomized-controlled, uni-blind, with three arms, parallel
