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

Hospital de Clínicas Dr. Manuel Quintela

Status: Completed

Conditions: Lactulose; Colonoscopy; Bowel Preparation; Polyethylene Glycol; Bisacodyl

Treatments: Drug: Lactulose; Drug: Polyethylene Glycol 3350

Study type: Interventional

Funder types: Other

Identifiers

NCT05726344

7477252

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

150 participants in 2 patient groups

Lactulose group

Experimental group

Description:

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.

Treatment:

Drug: Lactulose

Polyethylene glycol group

Experimental group

Description:

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.

Treatment:

Drug: Polyethylene Glycol 3350