Bowel Preparation for Colonoscopy With Oral Lactulose

NCT06282367 | Completed

• 1 other identifier: JOSE AGURTO TELLO HOSPITAL
• Study Type: observational
• Target: 222
• Locations: 1 country
• Sites: 1

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.

Conditions

Colonoscopy; Colonoscopy Preparation

Keywords

bowel preparation; oral lactulose; colonoscopy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• adenomas detection rate

  21 months

Study Arms (2)

Bowel preparation for colonoscopy using Polyethylene glycol

Bowel preparation for colonoscopy using oral Lactulose

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Data were extracted from a prospectively generated database, including consecutive outpatients from July 2021 to April 2023 who underwent diagnostic colonoscopy

You may qualify if:

• Patients age ≥ 18 years
• Colorectal cancer screening
• Lower gastrointestinal bleeding
• Iron deficiency anemia
• Chronic diarrhea

You may not qualify if:

• 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

Sponsors & Collaborators

• Josue Aliaga: lead

Study Sites (1)

Jose Agurto Tello Hospital

Lima, 05001, Peru

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 21 Months
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Gastroenterologist

Study Record Dates

• First Submitted: February 20, 2024
• First Posted: February 28, 2024
• Study Start: July 1, 2021
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

PE (1)