Predictive Factors of Inadequate Bowel Preparation in Inpatients

Colonoscopy Clinical Trial

— QIPS  

Official title:

Identification of Predictive Factors of Inadequate Bowel Preparation in Inpatients. The Quality-In-Patients Study (QIPS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03925506
• Other study ID #: QIPS observational study
• Status: Completed
• Start date: February 1, 2019
• Est. completion date: August 31, 2019

Study information

• Verified date: September 2019
• Source: Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1658
• Est. completion date: August 31, 2019
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bowel Preparation Solutions
• Colonoscopy
• Inpatient

Locations

Country	Name	City	State
Italy	Policlinico Sant'Orsola-Malpighi	Bologna

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