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

Colonoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05726344
• Other study ID #: 7477252
• Status: Completed
• Phase: N/A
• Start date: February 10, 2023
• Est. completion date: December 13, 2023

Study information

• Verified date: December 2023
• Source: Hospital de Clínicas Dr. Manuel Quintela
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 13, 2023
• Est. primary completion date: December 13, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bowel Preparation
• Colonoscopy
• Polyethylene Glycol

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Uruguay	Hospital de Clinicas	Montevideo

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clínicas Dr. Manuel Quintela

Country where clinical trial is conducted

Uruguay, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Assess tolerance between lactulose and Polyethylene Glycol.	To assess tolerance it will be considered: good tolerance those patients with 3 or less symptoms with no major criterion; regular tolerance those patients with 4-5 symptoms, without major criterion and bad tolerance those patients with 6 or more symptoms or 1 or more major criteria.	6 months
Secondary	Assess adherence between lactulose and Polyethylene Glycol.	To assess adherence it shall be assessed if the preparation was completed as well as the will to repeat the same preparation in the future.	6 months
Secondary	Assess side effects between lactulose and Polyethylene Glycol.	To assess side effects of both preparations that will be considered: nausea, vomiting, abdominal pain or bloating, sickness, lipothymia, palpitations, precordial pain, insomnia, anal pain or burning, dry mouth, tinnitus, unpleasant taste.	6 months
Secondary	Establish colonoscopy global adenoma detection rate with lactulose and Polyethylene Glycol.	It correspond to the number of adenomas/adenocarcinomas (histological diagnosis) divided by the total number of colonoscopies performed times 100.	6 months
Secondary	Establish colonoscopy cecal intubation rate in with lactulose and Polyethylene Glycol.	It correspond to the number colonoscopies visualizing ileocecal valve divided by the total number of colonoscopies performed times 100.	6 months