Barriers and Breakthroughs in IMPlementing Split Regimen OVEr Single Dose

The split-dose regimen (SpD) has demonstrated its superiority over the day-before regimen (DB) in determining a better colon cleansing and is considered the standard bowel preparation for colonoscopies by the American Society for Gastrointestinal Endoscopy (ASGE) and the European Society of Gastrointestinal Endoscopy (ESGE) guidelines. However its application is still suboptimal due to concerns about patient acceptability, fluid aspiration due to residual gastric contents and challenging viability for early morning colonoscopies. Barriers precluding the prescription of SpD have been explored in few studies mainly in the setting of auditing of current practice, while corrective measure aiming at changing this practice have been prospectively tested in very few, small and selected, cohorts. The present study has the aim of surveying split-dose regimen adoption rate among several endoscopic centres before and after an improvement phase following a plan-do-study-act approach, in order to analyse and correct factors preventing its adoption. A multivariate analysis was planned in order to use collected data to infer factors favouring and limiting split-dose regimen adoption.

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Key information

Conditions

Colonoscopy: Bowel Preparation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Subjects undergoing colonoscopy with full bowel cleansing

Exclusion criteria

Incapacity to give informed consent
Partial colonoscopy

Treatment and study plan

colonoscopy

Procedure

Bowel cleansing regimen

Drug

Primary outcomes

Number of participants adopting a split-dose regimen in Cycle1

Time frame: 6 months
Number of participants adopting a split-dose regimen in Cycle2

Time frame: 3 months
Change from Cycle1 in the proportion of patients adopting a split-dose regimen during Cycle2 after an improvement phase

Time frame: 9 months (Cycle1 = 6 months + Cycle2 = 3 months, separated by a 21-month improvement phase)

Sponsors and collaborators

Lead sponsor

S. Andrea Hospital

Other

Registry information

Official study title

IMPlementing Split Regimen OVEr Single Dose

Acronym: IMPROVES

Important dates

Study start: 2013
Primary completion: 2016
Study completion: 2018
First posted: Jul 10, 2018
Registry last updated: Jul 10, 2018

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.

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

Completed