Predictive Factors of Inadequate Bowel Preparation in Inpatients

NCT ID: NCT03925506

Last Updated: 2019-09-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1658 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-02-01
• Study Completion Date: 2019-08-31

Brief Summary

About 50-70% only of inpatients who undergo colonoscopy have an adequate bowel cleansing, which is far below the recommended threshold of 90%. Variables associated to inadequate colon preparation have not been assessed yet. Identifying such variables would allow to augment the diagnostic yield of colonoscopy, and also to reduce costs related to the need to repeat colonoscopy. Aim of the present study is to find variables independently associated to an inadequate bowel cleansing and to subsequently build and validate a predictive model, which could prove useful in clinical practice to identify hard-to-prepare inpatients. Secondary endpoints are (i) to assess the proportion of patients with inadequate colon cleansing, (ii) to run a cost-effectiveness analysis between patients with adequate cleansing and patients who need to repeat colonoscopy. Patients undergoing urgent colonoscopy, and patients who take the preparation at home will be excluded.

Conditions

Bowel Preparation Solutions; Colonoscopy; Inpatient

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

Inclusion Criteria

• Inpatient ≥18 y.o. who are scheduled elective colonoscopy during hospitalization irrespective of the indication.

Exclusion Criteria

• Urgent colonoscopy
• Patients who are not hospitalized when taking bowel preparation or when undergoing colonoscopy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role: lead

Responsible Party

Lorenzo Fuccio

Professor of Gastroenterology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Policlinico Sant'Orsola-Malpighi

Bologna, , Italy

Countries

Italy

References

Fuccio L, Frazzoni L, Spada C, Mussetto A, Fabbri C, Manno M, Aragona G, Zagari RM, Rondonotti E, Manes G, Occhipinti P, Cadoni S, Bazzoli F, Hassan C, Radaelli F; QIPS study group. Factors That Affect Adequacy of Colon Cleansing for Colonoscopy in Hospitalized Patients. Clin Gastroenterol Hepatol. 2021 Feb;19(2):339-348.e7. doi: 10.1016/j.cgh.2020.02.055. Epub 2020 Mar 18.

Reference Type: DERIVED

PMID: 32200083 (View on PubMed)

Other Identifiers

QIPS observational study

Identifier Type: -

Identifier Source: org_study_id