Clinical trial NCT03581175: Barriers and Breakthroughs in IMPlementing Split Regimen OVEr Single Dose
Official title: IMPlementing Split Regimen OVEr Single Dose
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colonoscopy: Bowel Preparation
Lead sponsor: S. Andrea Hospital
Sponsor class: OTHER
First posted: 2018-07-10
Enrollment: 8267
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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

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.


Eligibility criteria: Inclusion Criteria:

* Subjects undergoing colonoscopy with full bowel cleansing

Exclusion Criteria:

* Incapacity to give informed consent
* Partial colonoscopy

Primary outcomes:
measure: Number of participants adopting a split-dose regimen in Cycle1
timeFrame: 6 months
measure: Number of participants adopting a split-dose regimen in Cycle2
timeFrame: 3 months
measure: Change from Cycle1 in the proportion of patients adopting a split-dose regimen during Cycle2 after an improvement phase
timeFrame: 9 months (Cycle1 = 6 months + Cycle2 = 3 months, separated by a 21-month improvement phase)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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.
citation: 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.