Barriers and Breakthroughs in IMPlementing Split Regimen OVEr Single Dose

NCT ID: NCT03581175

Last Updated: 2018-07-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 8267 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2018-05-28

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.

Conditions

Colonoscopy: Bowel Preparation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Cycle1

Patients undergoing colonoscopy with full bowel cleansing before the improvement phase

Colonoscopy

Intervention Type: PROCEDURE

Bowel cleansing regimen

Intervention Type: DRUG

Cycle2

Patients undergoing colonoscopy with full bowel cleansing after the improvement phase

Colonoscopy

Intervention Type: PROCEDURE

Bowel cleansing regimen

Intervention Type: DRUG

Interventions

Colonoscopy

Intervention Type: PROCEDURE

Bowel cleansing regimen

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Subjects undergoing colonoscopy with full bowel cleansing

Exclusion Criteria

• Incapacity to give informed consent
• Partial colonoscopy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

S. Andrea Hospital

OTHER

Sponsor Role: lead

Responsible Party

Emilio Di Giulio

Head of Endoscopy Unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: BACKGROUND

PMID: 23335011 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25595062 (View on PubMed)

Other Identifiers

112-2013

Identifier Type: -

Identifier Source: org_study_id