Factors Related to a Persistent Inadequate Bowel Preparation for Colonoscopy

Colonic Disease Clinical Trial

— REPREP  

Official title:

Factors Related to a Persistent Inadequate Bowel Preparation After a Colonoscopy With Inadequate Colon Cleansing. An Observational Prospective Multicenter Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04693299
• Other study ID #: REPREP
• Status: Recruiting
• Start date: November 1, 2020
• Est. completion date: June 1, 2021

Study information

• Verified date: December 2020
• Source: Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
• Contact: Lorenzo Fuccio, MD
• Phone: +39 3383079255
• Email: lorenzofuccio[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 407
• Est. completion date: June 1, 2021
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colonic Disease
• Colonic Diseases

Intervention

Diagnostic Test:
• colonoscopy
A colonoscopy scheduled within the normal pathway of care will be performed. No interventions will be performed.

Locations

Country	Name	City	State
Italy	UOC Gastroenterologia ed Endoscopia Digestiva	Bologna	BO

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of factors related to persistent inadequate colon cleansing at repeat colonoscopy due to inadequate colon cleansing.	A logistic regression analysis will be run to identify such factors.	Outcome will be assessed during colonoscopy.
Secondary	Prevalence of persistent inadequate colon cleansing at repeat colonoscopy due to inadequate colon cleansing.	The prevalence of inadequate colon cleansing at repeat colonoscopy will be assessed	Outcome will be assessed during colonoscopy.