Barriers and Breakthroughs in IMPlementing Split Regimen OVEr Single Dose

IMPlementing Split Regimen OVEr Single Dose

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03581175

Acronym

IMPROVES

Enrollment

8267

Registered

2018-07-10

Start date

2013-09-30

Completion date

2018-05-28

Last updated

2018-07-10

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

Conditions

Colonoscopy: Bowel Preparation

Brief summary

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.

Interventions

PROCEDUREColonoscopy

DRUGBowel cleansing regimen

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Subjects undergoing colonoscopy with full bowel cleansing

Exclusion criteria

* Incapacity to give informed consent * Partial colonoscopy

Design outcomes

Primary

Measure	Time frame
Number of participants adopting a split-dose regimen in Cycle1	6 months
Number of participants adopting a split-dose regimen in Cycle2	3 months
Change from Cycle1 in the proportion of patients adopting a split-dose regimen during Cycle2 after an improvement phase	9 months (Cycle1 = 6 months + Cycle2 = 3 months, separated by a 21-month improvement phase)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026