Bowel Prep Acceptance in Clinical Practice

Colonoscopy: Bowel Preparation Clinical Trial

Official title:

Acceptance and Compliance of Split-dose Bowel Preparation for Colonoscopy in Clinical Practice

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02287051
• Other study ID #: 7/14
• Status: Completed
• Phase: N/A
• First received: October 12, 2014
• Last updated: November 5, 2014
• Start date: March 2014
• Est. completion date: October 2014

Study information

• Verified date: November 2014
• Source: Valduce Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial Summary

Bowel preparation for colonoscopy is crucial, since the diagnostic accuracy of the procedure depends on an adequate visualization of the mucosa of the colon.There is strong evidence that the quality of bowel preparation is inversely correlated with the interval between the end of the assumption of the purgative and the start of colonoscopy (shorter intervals are associated with higher levels of preparation).Recent studies have shown that split dose prep significantly improves the quality of bowel cleansing. In light of these data, both the American College of Gastroenterology (ACG) and the European Society of Gastrointestinal Endoscopy (ESGE) recommend now split dose prep in order to improve the quality of bowel cleansing. Despite these recommendations, the uptake of schemes in divided doses appears clearly underused in actual clinical practice. In particular, in Italy only a few centers routinely adopt the regime split as their first choice for the preparation for colonoscopy.The reasons why the "split dose" is under-utilized in clinical practice are not entirely clear, but probably in part reflecting gastroenterologists' concerns about potential elements that theoretically could make it less acceptable to the patient (get up early in the morning, potential problems during the journey from home to the hospital) The hypothesis of the study is that many patients would still be willing to accept these potential drawbacks if they were adequately informed about the positive impact of the scheme in divided doses on the effectiveness of bowel preparation, which results in higher reliability of the examination, shorter duration of the procedure, and less risk of rescheduling the exam in the near future

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1500
• Est. completion date: October 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• adult patientes undergoing colonscopy

Exclusion Criteria:

• afternoon colonoscopy

• partial colonoscopy

• ASA III-IV

• pregnancy

• incapacity to give informed consent

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colonoscopy: Bowel Preparation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Valduce Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	acceptance	structured questionnaire on acceptability and problems related to the modality of the preparation	3 month	No
Primary	compliance	structured questionnaire on completeness and difficulties related to the modality of the preparation	3 month	No