Clinical trial NCT05726344: Lactulose vs. Polyethylene Glycol as Bowel Preparation for Colonoscopy in Adults
Official title: Lactulose vs. Polyethylene Glycol as Bowel Preparation for Colonoscopy in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lactulose
Polyethylene Glycol
Bowel Preparation
Colonoscopy
Bisacodyl
Lead sponsor: Hospital de Clínicas Dr. Manuel Quintela
Sponsor class: OTHER
First posted: 2023-02-13
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Compare lactulose vs. Polyethylene Glycol as bowel cleansing preparation for colonoscopy
timeFrame: 6 months
measure: Establish Boston Bowel Preparation Scale inter and intra-observer variability
timeFrame: 7 months
Secondary outcomes:
measure: Assess tolerance between lactulose and Polyethylene Glycol.
timeFrame: 6 months
measure: Assess adherence between lactulose and Polyethylene Glycol.
timeFrame: 6 months
measure: Assess side effects between lactulose and Polyethylene Glycol.
timeFrame: 6 months
measure: Establish colonoscopy global adenoma detection rate with lactulose and Polyethylene Glycol.
timeFrame: 6 months
measure: Establish colonoscopy cecal intubation rate in with lactulose and Polyethylene Glycol.
timeFrame: 6 months
Other outcomes:
Locations:
city: Montevideo
country: Uruguay
facility: Hospital de Clinicas
Study officials:
affiliation: HOSPITAL DE CLINICAS
name: IGNACIO MORATORIO, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: HOSPITAL DE CLINICAS
name: MARIA B RUSSO, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: HOSPITAL DE CLINICAS
name: FLORENCIA RODRIGUEZ, MD
role: PRINCIPAL_INVESTIGATOR
References: