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Recruiting
NCT05726344
Lactulose vs. Polyethylene Glycol as Bowel Preparation for Colonoscopy in Adults
Conditions: Lactulose, Polyethylene Glycol, Bowel Preparation, Colonoscopy, Bisacodyl
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: 1
Phase: NA
Enrollment: 150
Sponsor: Hospital de Clínicas Dr. Manuel Quintela
Location: Uruguay
Summary
Colonoscopy is the gold standard in bowel assessment when there is suspicion of colon and rectum pathology.
Bowel cleansing is necessary to ensure an optimal visualization of colonic mucosa, allowing this form of detection and removal of polyps.
Nowadays international recommendations have multiple bowel preparations.
There are differences among them regarding adherence, tolerance and adverse effects.
Lactulose (LAC) is widely used in treating constipation.
However, there are some randomized clinical assays using LAC as bowel preparation with excellent results according to bowel preparation and tolerance scales.
Adherence to bowel preparation significantly affects the result in the endoscopic study.Safety of polyethylene glycol (PEG) formulations has been validated in several studies, it presents little severe side effects and the advantage of its applicability to patients with several comorbidities (heart, liver and kidney without water deprivation).
However, its main disadvantage lies in the need to ingest large amounts of liquid (3-4L), generating intolerance thereto in 15%-45% of patients.Bowel cleansing preparation with PEG is widely used in clinical practice.
Considering that according to international studies reporting better tolerance and adherence with LAC; it is suggested to compare the level of bowel preparation, tolerance and adherence between two groups with LAC and PEG.
Eligibility Criteria
Inclusion Criteria:- Patients over 18 years with no bowel surgical proceduresExclusion Criteria:Patients willingly deciding not to enter into the studyPregnant womenPatient with colonic resections and/or ileostomiesInflammatory bowel diseaseColonic optimization by prior colonoscopy with poor preparationSuspected intestinal occlusion or perforation, intussusceptionPatient with melenasOral iron intake in the past 10 daysEmergency colonoscopyHypersensitivity to any of the components comprised in preparations.DiabeticsChronic kidney disease in dialysisUncorrected severe dystoniasSevere psychiatric illness (schizophrenia)Low IQ to understand bowel preparationSevere constipation (< 1 weekly stool)Chronic diarrhea with high rate (≥ 4 daily evenly loose consistency stools for more than 4 weeks)Unbalanced heart diseases (ischemic cardiopathology, congestive heart failure, unstable angina, arrhythmias and untreatable high blood pressure)Ascites
Source: ClinicalTrials.gov (NCT05726344). StuddyBuddy aggregates publicly available trial information.