Predictive Factors of Inadequate Bowel Preparation in Inpatients

Completed

• Conditions: Colonoscopy; Bowel Preparation Solutions; Inpatient

• Registration Number: NCT03925506
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-01
• Study First Submitted: 2019-04-16
• Study First Submitted QC: 2019-04-23
• Study First Posted: 2019-04-24
• Primary Completion: 2019-08-31
• Study Completion: 2019-08-31
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-02
• Last Update Posted: 2019-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1658

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Inadequate bowel cleansing rate	At the end of the study, 3 months after the beginning of the study.	The number of inpatients with inadequate bowel preparation over the total number of patients enrolled. Bowel prep will be assessed according to the Boston Bowel Preparation Scale (BBPS). A score less than 2 at one segment of the colon will be considered as inadequate bowel preparation.

Secondary Outcome Measures

Name	Time	Method
Rate of patients scheduled for colonoscopy repetition due to inadequate bowel preparation	At the end of the study, 3 months after the beginning of the study.	Total number of patients scheduled for repeating colonoscopy over the total number of patients enrolled scheduled for repeating colonoscopy due to poor bowel pre.

Trial Locations

Locations (1)

Policlinico Sant'Orsola-Malpighi; 🇮🇹 Bologna, Italy