Colorectal neoplasia
Conditions
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 u
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
Sponsors
Hospital Geral Roberto Santos
Hospital Geral Roberto Santos
Eligibility
Inclusion criteria
Inclusion criteria: Patients older than 18 years; signature of the TCLE; colonoscopy indication
Exclusion criteria
Exclusion criteria: Patients with a history of coronary syndrome; heart, kidney or liver failure; intestinal obstruction or semi-obstruction; previous colectomy; hydroelectrolytic disorders; INR> 2.5 and / or Platelets <40,000
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected that the lactitol oral solution will show better tolerance and less frequency of adverse events compared to patients submitted to preparation with 20% mannitol and PEG-macrogol. Questionnaire will be applied to assess tolerability and adverse events will be cataloged and analyzed according to intensity and causal association with colon preparation solutions.;It is expected that the group submitted to colonic cleaning with lactitol solution presents a lower frequency of serum changes in sodium and potassium. Serum level will be assessed before and immediately after patients' colon cleansing for this analysis | — |
Countries
Brazil
Contacts
Public ContactLourianne Cavalcante
Hospital Geral Roberto Santos
Outcome results
None listed