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

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.

Study Overview

• Status: Completed
• Conditions: Colonoscopy: Bowel Preparation
• Intervention / Treatment: Procedure: Colonoscopy; Drug: Bowel cleansing regimen

• Study Type: Observational
• Enrollment (Actual): 8267

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Every inpatient or outpatient undergoing a complete colonoscopy with full bowel cleansing for any indication in one of the participating centres in Central Italy

Description

Inclusion Criteria:

• Subjects undergoing colonoscopy with full bowel cleansing

Exclusion Criteria:

• Incapacity to give informed consent
• Partial colonoscopy

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cycle1; Patients undergoing colonoscopy with full bowel cleansing before the improvement phase	Procedure: Colonoscopy; Drug: Bowel cleansing regimen
Cycle2; Patients undergoing colonoscopy with full bowel cleansing after the improvement phase	Procedure: Colonoscopy; Drug: Bowel cleansing regimen

What is the study measuring?

Primary Outcome Measures

Outcome 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)

Collaborators and Investigators

• Sponsor: S. Andrea Hospital

Publications and helpful links

General Publications

• Hassan C, Bretthauer M, Kaminski MF, Polkowski M, Rembacken B, Saunders B, Benamouzig R, Holme O, Green S, Kuiper T, Marmo R, Omar M, Petruzziello L, Spada C, Zullo A, Dumonceau JM; European Society of Gastrointestinal Endoscopy. Bowel preparation for colonoscopy: European Society of Gastrointestinal Endoscopy (ESGE) guideline. Endoscopy. 2013;45(2):142-50. doi: 10.1055/s-0032-1326186. Epub 2013 Jan 18.
• ASGE Standards of Practice Committee; Saltzman JR, Cash BD, Pasha SF, Early DS, Muthusamy VR, Khashab MA, Chathadi KV, Fanelli RD, Chandrasekhara V, Lightdale JR, Fonkalsrud L, Shergill AK, Hwang JH, Decker GA, Jue TL, Sharaf R, Fisher DA, Evans JA, Foley K, Shaukat A, Eloubeidi MA, Faulx AL, Wang A, Acosta RD. Bowel preparation before colonoscopy. Gastrointest Endosc. 2015 Apr;81(4):781-94. doi: 10.1016/j.gie.2014.09.048. Epub 2015 Jan 14. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2013
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): May 28, 2018

Study Registration Dates

• First Submitted: June 14, 2018
• First Submitted That Met QC Criteria: July 7, 2018
• First Posted (Actual): July 10, 2018

Study Record Updates

• Last Update Posted (Actual): July 10, 2018
• Last Update Submitted That Met QC Criteria: July 7, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 112-2013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No