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NCT06282367 Clinical Trial

Bowel Preparation for Colonoscopy With Oral Lactulose

Colonoscopy Clinical Trial

Official title:
Novel Regimen for Colonoscopy Bowel Preparation With Oral Lactulose: A Prospective Comparative Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06282367
Other study ID # JOSE AGURTO TELLO HOSPITAL
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 1, 2021
Est. completion date April 1, 2023

Study information
Verified date February 2024
Source Hospital Jose Agurto Tello
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Background and Aims: The quality of colonoscopy is critically influenced by bowel preparation. Polyethylene glycol (PEG) is considered the gold standard regimen for bowel preparation, however due to the necessity of large volume of patient's tolerance is impaired, especially in the elderly population. Lactulose has been adopted in a few centers as a novel alternative for colonoscopy preparation. This study aimed to investigate the efficacy-safety profile of a lactulose-based bowel preparation in comparison to PEG for colonoscopy. Methods: Prospective non-blinded comparative study, developed in two tertiary centers from July 2021 to April 2023. Outpatients undergoing colonoscopy were randomly divided into 2 groups: Group 1 (111 patients): PEG and Group 2 (111 patients): Lactulose. The following clinical outcomes were assessed for each group: degree of bowel clearance using the Boston Score, colorectal polyp detection rate, adenoma detection rate, tolerability and side effects.

Recruitment information / eligibility
Status Completed
Enrollment 222
Est. completion date April 1, 2023
Est. primary completion date April 1, 2023
Accepts healthy volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Patients age = 18 years - Colorectal cancer screening - Lower gastrointestinal bleeding - Iron deficiency anemia - Chronic diarrhea Exclusion Criteria: - Patients with previous colorectal surgery - Pregnant - Emergency colonoscopies - Use of any other scheme or substance for bowel preparation different from those studied - Incomplete information - Clinical conditions considered unsuitable for sedation or colonoscopy

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Peru Jose Agurto Tello Hospital Lima

Sponsors (1)
Lead Sponsor Collaborator
Josue Aliaga

Country where clinical trial is conducted

Peru, 

Outcome
Type Measure Description Time frame Safety issue
Primary Degree of bowel cleansing using the Boston score minimum value: 0 (worse outcome: inadequate bowel preparation); maximum value: 9 (better outcome: adequate bowel preparation) 21 month
Secondary adenomas detection rate 21 months
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