Skip to main content
OpenTrials
Completed

NCT Number: NCT06282367

Bowel Preparation for Colonoscopy With Oral Lactulose

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Colonoscopy Colonoscopy Preparation

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Jose Agurto Tello Hospital

Lima, 05001, Peru

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Degree of bowel cleansing using the Boston score

    Time frame: 21 month

    minimum value: 0 (worse outcome: inadequate bowel preparation); maximum value: 9 (better outcome: adequate bowel preparation)

Secondary outcomes

  1. adenomas detection rate

    Time frame: 21 months

Sponsors and collaborators

Lead sponsor

Josue Aliaga

Other Gov

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 28, 2024
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.