Barriers and Breakthroughs in IMPlementing Split Regimen OVEr Single Dose (IMPROVES)

S. Andrea Hospital

Status: Completed

Conditions: Colonoscopy: Bowel Preparation

Treatments: Procedure: Colonoscopy; Drug: Bowel cleansing regimen

Study type: Observational

Funder types: Other

Identifiers

NCT03581175

112-2013

Details and patient eligibility

About

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.

Enrollment: 8,267 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects undergoing colonoscopy with full bowel cleansing

Exclusion criteria

• Incapacity to give informed consent
• Partial colonoscopy

Trial design

8,267 participants in 2 patient groups

Cycle1

Description:

Patients undergoing colonoscopy with full bowel cleansing before the improvement phase

Treatment:

Procedure: Colonoscopy

Drug: Bowel cleansing regimen

Cycle2

Description:

Patients undergoing colonoscopy with full bowel cleansing after the improvement phase

Treatment:

Procedure: Colonoscopy

Drug: Bowel cleansing regimen