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Clinical Trials/NCT03581175
NCT03581175CompletedNot Applicable

IMPlementing Split Regimen OVEr Single Dose

S. Andrea Hospital0 sites8,267 target enrollmentStarted: September 2013Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
8,267
Primary Endpoint
Number of participants adopting a split-dose regimen in Cycle1

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Subjects undergoing colonoscopy with full bowel cleansing

Exclusion Criteria

  • •Incapacity to give informed consent
  • •Partial colonoscopy

Arms & Interventions

Cycle1

Patients undergoing colonoscopy with full bowel cleansing before the improvement phase

Intervention: Colonoscopy (Procedure)

Cycle1

Patients undergoing colonoscopy with full bowel cleansing before the improvement phase

Intervention: Bowel cleansing regimen (Drug)

Cycle2

Patients undergoing colonoscopy with full bowel cleansing after the improvement phase

Intervention: Colonoscopy (Procedure)

Cycle2

Patients undergoing colonoscopy with full bowel cleansing after the improvement phase

Intervention: Bowel cleansing regimen (Drug)

Outcomes

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)

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
S. Andrea Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Emilio Di Giulio

Head of Endoscopy Unit

S. Andrea Hospital

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