Clinical trial

Lactulose vs. Polyethylene Glycol as Bowel Preparation for Colonoscopy in Adults

Name
7477252
Description
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.
Trial arms
Trial start
2023-02-10
Estimated PCD
2023-12-13
Trial end
2023-12-13
Status
Completed
Treatment
Lactulose
4 tablets of Bisacodyl (5 mg) + 250 mL (162.5g lactulose) of lactulose + 600 mL of water + 2 L of water
Arms:
Lactulose group
Other names:
Bisacodyl 20 mg, Water 600 mL
Polyethylene Glycol 3350
4 tablets of Bisacodyl (5 mg) + 3 bottles Polyethylene Glycol 3350 (Polyethylene glycol 3350 60 g; sodium chloride 1.46 g; potassium chloride 745 mg; Sodium bicarbonate 1.68 g; anhydrous sodium sulfate 5.68 g; pineapple flavoring 483 mg) + 3 L of water
Arms:
Polyethylene glycol group
Other names:
Bisacodyl 20 mg, Water 3 L
Size
150
Primary endpoint
Compare lactulose vs. Polyethylene Glycol as bowel cleansing preparation for colonoscopy
6 months
Establish Boston Bowel Preparation Scale inter and intra-observer variability
7 months
Eligibility criteria
Inclusion Criteria: - Patients over 18 years with no bowel surgical procedures Exclusion Criteria: * Patients willingly deciding not to enter into the study * Pregnant women * Patient with colonic resections and/or ileostomies * Inflammatory bowel disease * Colonic optimization by prior colonoscopy with poor preparation * Suspected intestinal occlusion or perforation, intussusception * Patient with melenas * Oral iron intake in the past 10 days * Emergency colonoscopy * Hypersensitivity to any of the components comprised in preparations. * Diabetics * Chronic kidney disease in dialysis * Uncorrected severe dystonias * Severe psychiatric illness (schizophrenia) * Low IQ to understand bowel preparation * Severe 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'An analytical, experimental, prospective study, specifically a triple blind randomized clinical assay (endoscopist, researchers and statistician) in which a bowel preparation is compared for colonoscopy with lactulose vs. Polyethylene Glycol.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'Triple blind (endoscopist, researchers and statistician) randomized clinical assay.', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 150, 'type': 'ACTUAL'}}
Updated at
2023-12-27

1 organization

2 products

5 indications

Product
Lactulose
Indication
Lactulose
Indication
PEG
Indication
Colonoscopy
Indication
Bisacodyl