Factors Related to a Persistent Inadequate Bowel Preparation for Colonoscopy

NCT ID: NCT04693299

Last Updated: 2021-01-05

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

UNKNOWN

Total Enrollment

407 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-01

Study Completion Date

2021-06-01

Brief Summary

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Adequate bowel preparation for colonoscopy has an extremely relevant impact on diagnostic yield and procedural success. The guidelines recommend an adequate colon cleansing rate of at least 90% of procedures. It has been shown that patients with inadequate colon cleansing history have a high probability of not reaching an adequate bowel preparation again.

Surprisingly, no evidence-based recommendations are available regarding bowel preparation in the patient with inadequate colon cleansing history. Therefore, identifying the factors associated with repeated inadequacy of bowel cleansing is crucial in order to define the best preparation strategy in this subset of patients. The implications for patients and for healthcare system are many: improving the quality of bowel preparation would reduce the need to repeat colonoscopy and the risk of conducting unreliable examinations. Furthermore, it would reduce the costs for the healthcare system by avoiding to overload endoscopic units.

Inclusion criteria:

Outpatient and hospitalized patients, adults, candidates for colonoscopy for any pathology, as part of the normal care process, with the need to repeat bowel preparation due to inadequate cleansing.

Exclusion criteria:

* Emergency regime
* Inability to obtain consent
* Refusal of the patient

Primary end-point:

Identification of factors independently associated with repeated inadequate colon cleansing after inadequate bowel preparation at previous colonoscopy, and consequent development (and validation) of a predictive model.

The colon cleansing will be evaluated according to the Boston Bowel Preparation Scale (BBPS), which assigns a score from 0 (presence of solid stools) to 3 (excellent visualization of the colonic mucosa) for each of the three main segments of the colon, i.e. right colon, transverse colon and left-rectum colon. Colon cleansing will be judged inadequate in case of a total score \<6 or a score \<2 even in only one of the colic segments.

Secondary end-point:

• Assess the prevalence of repeated inadequate bowel cleansing in the patient with previous inadequate cleansing

Detailed Description

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Conditions

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Colonic Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Study cohort

Inclusion criteria:

Outpatient and hospitalized patients, adults, candidates for colonoscopy for any pathology, as part of the normal care process, with the need to repeat bowel preparation due to inadequate cleansing.

Exclusion criteria:

* Emergency regime
* Inability to obtain consent
* Refusal of the patient

colonoscopy

Intervention Type DIAGNOSTIC_TEST

A colonoscopy scheduled within the normal pathway of care will be performed. No interventions will be performed.

Interventions

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colonoscopy

A colonoscopy scheduled within the normal pathway of care will be performed. No interventions will be performed.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Outpatients or hospitalized patients
* adults
* candidates for colonoscopy for any pathology, in the normal pathway of care, with the need to repeat the bowel preparation due to inadequate colon cleansing.

Exclusion Criteria

* Emergency regimen
* Inability to obtain consent
* Patient refusal
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role lead

Responsible Party

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Lorenzo Fuccio

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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UOC Gastroenterologia ed Endoscopia Digestiva

Bologna, BO, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Lorenzo Fuccio, MD

Role: CONTACT

+39 3383079255

Facility Contacts

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Lorenzo Fuccio, MD

Role: primary

+39 3383079255

Other Identifiers

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REPREP

Identifier Type: -

Identifier Source: org_study_id

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