Barriers and Breakthroughs in IMPlementing Split Regimen OVEr Single Dose

NCT03581175 | Completed

• 1 other identifier: 112-2013
• Study Type: observational
• Target: 8,267
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (3)

• 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)

Study Arms (2)

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

Interventions

Colonoscopy PROCEDURE

Cycle1; Cycle2

Bowel cleansing regimen DRUG

Cycle1; Cycle2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Subjects undergoing colonoscopy with full bowel cleansing

You may not qualify if:

• Incapacity to give informed consent
• Partial colonoscopy

Sponsors & Collaborators

• S. Andrea Hospital: lead

Related Publications (2)

• 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.

  PMID: 23335011 BACKGROUND

• 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.

  PMID: 25595062 BACKGROUND

MeSH Terms

Interventions

Colonoscopy

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Endoscopy Unit

Study Record Dates

• First Submitted: June 14, 2018
• First Posted: July 10, 2018
• Study Start: September 1, 2013
• Primary Completion: February 1, 2016
• Study Completion: May 28, 2018
• Last Updated: July 10, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share