Barriers and Breakthroughs in IMPlementing Split Regimen OVEr Single Dose

Colonoscopy: Bowel Preparation Clinical Trial

— IMPROVES  

Official title:

IMPlementing Split Regimen OVEr Single Dose

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03581175
• Other study ID #: 112-2013
• Status: Completed
• Start date: September 2013
• Est. completion date: May 28, 2018

Study information

• Verified date: July 2018
• Source: S. Andrea Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8267
• Est. completion date: May 28, 2018
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects undergoing colonoscopy with full bowel cleansing

Exclusion Criteria:

• Incapacity to give informed consent

• Partial colonoscopy

Related Conditions & MeSH terms

• Colonoscopy: Bowel Preparation

Intervention

Procedure:
• Colonoscopy

Drug:
• Bowel cleansing regimen

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
S. Andrea Hospital

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants adopting a split-dose regimen in Cycle1		6 months
Primary	Number of participants adopting a split-dose regimen in Cycle2		3 months
Primary	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)