Lactulose vs. Polyethylene Glycol as Bowel Preparation for Colonoscopy in Adults
NCT ID: NCT05726344
Last Updated: 2023-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
150 participants
INTERVENTIONAL
2023-02-10
2023-12-13
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Lactulose group
Patients participating in the study shall go on with their usual diet prior to colonoscopy. Three days before avoid consuming fruits, vegetables, seeds and cereals. A low residue soft and liquid diet is allowed.
The day before the study, the group receiving lactulose shall take 4 tablets of Bisacodyl (5 mg) the day before the study at 6pm. Then, at 8pm a bottle of 250 mL (162.5g lactulose) of lactulose shall be dissolved in 600 mL of water and all contents (850 mL) shall be taken in 2 hours. At 10pm they have to drink 2 liters still water.
Lactulose
4 tablets of Bisacodyl (5 mg) + 250 mL (162.5g lactulose) of lactulose + 600 mL of water + 2 L of water
Polyethylene glycol group
Patients participating in the study shall go on with their usual diet prior to colonoscopy. Three days before avoid consuming fruits, vegetables, seeds and cereals. A low residue soft and liquid diet is allowed.
The day before the study, the group receiving polyethylene glycol (PEG) should take 4 tablets of Bisacodyl (5 mg) at 4pm. Then, at 6pm, 3 bottles of PEG (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) shall be dissolved in 3 liters of water (1 bottle per liter) and they shall take half the preparation, that is 1 liter and a half in 2 hours. At 10pm they shall take the remaining contents in 2 hours.
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
Interventions
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Lactulose
4 tablets of Bisacodyl (5 mg) + 250 mL (162.5g lactulose) of lactulose + 600 mL of water + 2 L of water
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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Hospital de Clínicas Dr. Manuel Quintela
OTHER
Responsible Party
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Ignacio Moratorio
Principal Investigator
Principal Investigators
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IGNACIO MORATORIO, MD
Role: PRINCIPAL_INVESTIGATOR
HOSPITAL DE CLINICAS
MARIA B RUSSO, MD
Role: PRINCIPAL_INVESTIGATOR
HOSPITAL DE CLINICAS
FLORENCIA RODRIGUEZ, MD
Role: PRINCIPAL_INVESTIGATOR
HOSPITAL DE CLINICAS
Locations
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Hospital de Clinicas
Montevideo, , Uruguay
Countries
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Other Identifiers
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7477252
Identifier Type: -
Identifier Source: org_study_id