Factors Related to a Persistent Inadequate Bowel Preparation for Colonoscopy

NCT04693299 | Unknown

• 1 other identifier: REPREP
• Study Type: observational
• Target: 407
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Colonic Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Prevalence of persistent inadequate colon cleansing at repeat colonoscopy due to inadequate colon cleansing.

  Outcome will be assessed during colonoscopy.

Study Arms (1)

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

Diagnostic Test: colonoscopy

Interventions

colonoscopy DIAGNOSTIC_TEST

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

Study cohort

Eligibility Criteria

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

Study Population

Outpatient and hospitalized adult patients, 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.

You may qualify if:

• 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.

You may not qualify if:

• Emergency regimen
• Inability to obtain consent
• Patient refusal

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

UOC Gastroenterologia ed Endoscopia Digestiva

Bologna, BO, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Colonic Diseases

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

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

Central Study Contacts

Lorenzo Fuccio, MD

CONTACT

+39 3383079255; lorenzofuccio@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 29, 2020
• First Posted: January 5, 2021
• Study Start: November 1, 2020
• Primary Completion: May 1, 2021
• Study Completion: June 1, 2021
• Last Updated: January 5, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)