Barriers and Breakthroughs in IMPlementing Split Regimen OVEr Single Dose

Completed

• Conditions: Colonoscopy: Bowel Preparation
• Interventions: Procedure: Colonoscopy; Drug: Bowel cleansing regimen

• Registration Number: NCT03581175
• Lead Sponsor: S. Andrea Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Primary Completion: 2016-02
• Study Completion: 2018-05-28
• Study First Submitted: 2018-06-14
• Status Verified: 2018-07
• Study First Submitted QC: 2018-07-07
• Last Update Submitted: 2018-07-07
• Study First Posted: 2018-07-10
• Last Update Posted: 2018-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8267

Inclusion Criteria

• Subjects undergoing colonoscopy with full bowel cleansing

Exclusion Criteria

• Incapacity to give informed consent
• Partial colonoscopy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cycle1	Colonoscopy	Patients undergoing colonoscopy with full bowel cleansing before the improvement phase
Cycle1	Bowel cleansing regimen	Patients undergoing colonoscopy with full bowel cleansing before the improvement phase
Cycle2	Colonoscopy	Patients undergoing colonoscopy with full bowel cleansing after the improvement phase
Cycle2	Bowel cleansing regimen	Patients undergoing colonoscopy with full bowel cleansing after the improvement phase

Primary Outcome Measures

Name	Time	Method
Number of participants adopting a split-dose regimen in Cycle2	3 months
Number of participants adopting a split-dose regimen in Cycle1	6 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)