Bowel Preparation for Colonoscopy With Oral Lactulose

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06282367

Enrollment

222

Registered

2024-02-28

Start date

2021-07-01

Completion date

2023-04-01

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colonoscopy, Colonoscopy Preparation

Keywords

bowel preparation, oral lactulose, colonoscopy

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Degree of bowel cleansing using the Boston score	21 month	minimum value: 0 (worse outcome: inadequate bowel preparation); maximum value: 9 (better outcome: adequate bowel preparation)

Secondary

Measure	Time frame
adenomas detection rate	21 months

Countries

Peru

Outcome results