Bowel Prep Acceptance in Clinical Practice

NCT ID: NCT02287051

Last Updated: 2014-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-03-31

Study Completion Date

2014-10-31

Brief Summary

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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

Detailed Description

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Conditions

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Colonoscopy: Bowel Preparation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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colonoscopy population

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* adult patientes undergoing colonscopy

Exclusion Criteria

* afternoon colonoscopy
* partial colonoscopy
* ASA III-IV
* pregnancy
* incapacity to give informed consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Valduce Hospital

OTHER

Sponsor Role lead

Responsible Party

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Arnaldo Amato

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Radaelli F, Paggi S, Repici A, Gullotti G, Cesaro P, Rotondano G, Cugia L, Trovato C, Spada C, Fuccio L, Occhipinti P, Pace F, Fabbri C, Buda A, Manes G, Feliciangeli G, Manno M, Barresi L, Anderloni A, Dulbecco P, Rogai F, Amato A, Senore C, Hassan C. Barriers against split-dose bowel preparation for colonoscopy. Gut. 2017 Aug;66(8):1428-1433. doi: 10.1136/gutjnl-2015-311049. Epub 2016 Apr 19.

Reference Type DERIVED
PMID: 27196589 (View on PubMed)

Other Identifiers

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7/14

Identifier Type: -

Identifier Source: org_study_id