Bowel Preparation for Colonoscopy With Oral Lactulose

NCT ID: NCT06282367

Last Updated: 2024-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

222 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-01

Study Completion Date

2023-04-01

Brief Summary

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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.

Detailed Description

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Conditions

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Colonoscopy Colonoscopy Preparation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Bowel preparation for colonoscopy using Polyethylene glycol

No interventions assigned to this group

Bowel preparation for colonoscopy using oral Lactulose

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Josue Aliaga

OTHER_GOV

Sponsor Role lead

Responsible Party

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Josue Aliaga

Gastroenterologist

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Jose Agurto Tello Hospital

Lima, , Peru

Site Status

Countries

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Peru

Other Identifiers

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JOSE AGURTO TELLO HOSPITAL

Identifier Type: -

Identifier Source: org_study_id

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