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

NCT05726344 | Completed

• 1 other identifier: 7477252
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lactulose; Polyethylene Glycol; Bowel Preparation; Colonoscopy; Bisacodyl

Outcome Measures

Primary Outcomes (2)

• Compare lactulose vs. Polyethylene Glycol as bowel cleansing preparation for colonoscopy

  Compare the level of bowel preparation (by Boston Bowel Preparation Scale) between two groups with lactulose and Polyethylene Glycol. The minimum and maximum value is 0 and 9, respectively. A proper preparation is consider a Boston Bowel Preparation Scale ≥ 2 scores in each colonic segment. Unsuitable preparation a Boston Bowel Preparation Scale \< 2 scores in any of the segments. Score 0: is considered a segment of unprepared colon with mucosa that cannot be observed given the presence of solid stool which does not disappear after cleansing. Score 1: part of the colonic mucosa is observed; other areas cannot be suitably assessed given the presence of staining, residual matter and/or opaque liquid. Score 2: little remaining residual matter and small matter fragments which do not prevent correct visualization of colonic mucosa in said segment. Score 3: colonic mucosa which can be entirely observed with no residual matter nor small fragments of matter and opaque liquid.

  6 months

• Establish Boston Bowel Preparation Scale inter and intra-observer variability

  Two researchers shall review the endoscopic study videos and they shall complete the Boston Bowel Preparation Scale inter-observer questionnaire. Results obtained by the endoscopist in charge of the study and the observers shall be compared so as to establish inter-observer variability. Researchers shall analyze one month later again all colonoscopies recorded thus establishing Boston Bowel Preparation Scale of each endoscopy. Then results previously established shall be compared so as to establish intra-observer variability. The minimum and maximum value is 0 and 9, respectively. A proper preparation is consider a Boston Bowel Preparation Scale ≥ 2 scores in each colonic segment. Unsuitable preparation a Boston Bowel Preparation Scale \< 2 scores in any of the segments.

  7 months

Secondary Outcomes (5)

• Assess tolerance between lactulose and Polyethylene Glycol.

  6 months

• Assess adherence between lactulose and Polyethylene Glycol.

  6 months

• Assess side effects between lactulose and Polyethylene Glycol.

  6 months

• Establish colonoscopy global adenoma detection rate with lactulose and Polyethylene Glycol.

  6 months

• Establish colonoscopy cecal intubation rate in with lactulose and Polyethylene Glycol.

  6 months

Study Arms (2)

Lactulose group

EXPERIMENTAL

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.

Drug: Lactulose

Polyethylene glycol group

EXPERIMENTAL

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.

Drug: Polyethylene Glycol 3350

Interventions

Lactulose DRUG

4 tablets of Bisacodyl (5 mg) + 250 mL (162.5g lactulose) of lactulose + 600 mL of water + 2 L of water

Also known as: Bisacodyl 20 mg, Water 600 mL

Lactulose group

Polyethylene Glycol 3350 DRUG

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

Also known as: Bisacodyl 20 mg, Water 3 L

Polyethylene glycol group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Patients over 18 years with no bowel surgical procedures

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital de Clínicas Dr. Manuel Quintela: lead

Study Sites (1)

Hospital de Clinicas

Montevideo, Uruguay

Location

MeSH Terms

Interventions

Lactulose; Bisacodyl; Water; polyethylene glycol 3350

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars; Cresols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• IGNACIO MORATORIO, MD

  HOSPITAL DE CLINICAS

  PRINCIPAL INVESTIGATOR

• MARIA B RUSSO, MD

  HOSPITAL DE CLINICAS

  PRINCIPAL INVESTIGATOR

• FLORENCIA RODRIGUEZ, MD

  HOSPITAL DE CLINICAS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Triple blind (endoscopist, researchers and statistician) randomized clinical assay.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: January 18, 2023
• First Posted: February 13, 2023
• Study Start: February 10, 2023
• Primary Completion: December 13, 2023
• Study Completion: December 13, 2023
• Last Updated: December 27, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: ENDED THE TRIAL

Locations

UR (1)